<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03765073</url>
  </required_header>
  <id_info>
    <org_study_id>C1091002</org_study_id>
    <secondary_id>2020-005074-96</secondary_id>
    <nct_id>NCT03765073</nct_id>
  </id_info>
  <brief_title>Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Nonpregnant Women And Pregnant Women And Their Infants</brief_title>
  <official_title>A PHASE 1/2, RANDOMIZED, PLACEBO-CONTROLLED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE IN HEALTHY NONPREGNANT WOMEN AND PREGNANT WOMEN 18 TO 40 YEARS OF AGE AND THEIR INFANTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety,&#xD;
      tolerability and immunogenicity of the investigational multivalent group B streptococcus&#xD;
      vaccine administered at one dose level (various formulations) in healthy nonpregnant women&#xD;
      (various formulations at one dose level), and then in healthy pregnant women (various&#xD;
      formulations at three dose levels), and finally in healthy pregnant women at a selected dose&#xD;
      level/formulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Anticipated">March 10, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 10, 2024</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the participant, will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentages of nonpregnant women reporting prompted local reactions within 7 days following primary and booster doses of investigational product (pain at the injection site, redness, and swelling).</measure>
    <time_frame>Day 7</time_frame>
    <description>Describe prompted local reactions for nonpregnant women following investigational product administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of nonpregnant women reporting prompted systemic events within 7 days following primary and booster doses of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).</measure>
    <time_frame>Day 7</time_frame>
    <description>Describe prompted systemic events for nonpregnant women following investigational product administration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of nonpregnant women reporting adverse events (AEs) through 1 month following administration of the primary and booster doses of investigational product.</measure>
    <time_frame>1 month following administration of investigational product</time_frame>
    <description>Describe AEs for nonpregnant women occurring through 1 month following administration of investigational product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of nonpregnant women reporting SAEs through 6 months following administration of the primary dose of investigational product.</measure>
    <time_frame>6 months following administration of investigational product</time_frame>
    <description>Describe SAEs for nonpregnant women through 6 months following administration of investigational product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of sentinel-cohort maternal participants (Stage 2 only) with clinical laboratory abnormalities following administration of investigational product at the 2-week follow-up visit.</measure>
    <time_frame>2 weeks following administration of investigational product</time_frame>
    <description>Describe clinical laboratory abnormalities for maternal participants (Stage 2 only) following administration of investigational product at 2-week follow-up visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of maternal participants reporting prompted local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).</measure>
    <time_frame>Day 7</time_frame>
    <description>Describe prompted local reactions for maternal participants within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of maternal participants reporting prompted systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).</measure>
    <time_frame>Day 7</time_frame>
    <description>Describe prompted systemic events for maternal participants within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of maternal participants reporting AEs through 1 month after administration of investigational product.</measure>
    <time_frame>1 month after administration of investigational product</time_frame>
    <description>Describe AEs through 1 month after administration of investigational product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of maternal participants with SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) throughout the study (Visit 1 through the 12-month postdelivery study visit).</measure>
    <time_frame>12 months after delivery</time_frame>
    <description>Describe SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) for maternal participants throughout the study (Visit 1 through the 12-month postdelivery study visit).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of maternal participants with each delivery outcome (live birth, delivery mode).</measure>
    <time_frame>Delivery</time_frame>
    <description>Describe delivery outcomes (live birth, delivery mode) for maternal participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of infant participants with specific birth outcomes.</measure>
    <time_frame>Birth</time_frame>
    <description>Describe specific birth outcomes for infant participants.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of infant participants with AEs from birth to 6 weeks of age.</measure>
    <time_frame>6 weeks of age</time_frame>
    <description>Describe AEs for infant participants from birth to 6 weeks of age.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of infant participants with SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs through 12 months of age.</measure>
    <time_frame>12 months of age</time_frame>
    <description>Describe SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs for infant participants through 12 months of age.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of nonpregnant women reporting SAEs approximately 7 to 12 months following the booster doses of investigational product.</measure>
    <time_frame>7 to 12 months following administration of investigational product</time_frame>
    <description>Describe SAEs for nonpregnant women 7 to 12 months following administration of investigational product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of nonpregnant women reporting medically attended adverse events (MAEs) through 6 months following administration of the primary dose of investigational product.</measure>
    <time_frame>6 months following administration of investigational product</time_frame>
    <description>Describe MAEs for nonpregnant women through 6 months following administration of investigational product.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of nonpregnant women reporting medically attended adverse events (MAEs) approximately 7 to 12 months following the booster doses of investigational product.</measure>
    <time_frame>7 to 12 months following administration of investigational product</time_frame>
    <description>Describe MAEs for nonpregnant women 7 to 12 months following administration of investigational product.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Group B streptococcus (GBS) serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.</measure>
    <time_frame>1 month after vaccination</time_frame>
    <description>Describe GBS serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal participants.</measure>
    <time_frame>2 weeks after vaccination</time_frame>
    <description>Describe GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GBS serotype-specific IgG GMCs in infant participants measured at birth.</measure>
    <time_frame>Birth</time_frame>
    <description>Describe GBS serotype-specific IgG GMCs in infant participants measured at birth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GBS serotype-specific OPA GMTs in infant participants measured at birth.</measure>
    <time_frame>Birth</time_frame>
    <description>Describe GBS serotype-specific OPA GMTs in infant participants measured at birth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal participants.</measure>
    <time_frame>1 month after vaccination</time_frame>
    <description>Describe GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GBS serotype-specific IgG GMCs measured at delivery in maternal participants.</measure>
    <time_frame>Delivery</time_frame>
    <description>Describe GBS serotype-specific IgG GMCs measured at delivery in maternal participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal participants.</measure>
    <time_frame>1 month after vaccination</time_frame>
    <description>Describe GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GBS serotype-specific OPA GMTs measured at delivery in maternal participants.</measure>
    <time_frame>Delivery</time_frame>
    <description>Describe GBS serotype-specific OPA GMTs measured at delivery in maternal participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GBS serotype-specific IgG geometric mean concentrations (GMCs) measured before a booster vaccination in nonpregnant women</measure>
    <time_frame>Before booster vaccination</time_frame>
    <description>Describe GBS serotype-specific IgG GMCs measured before a booster vaccination in nonpregnant women</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 1 month after a booster vaccination in nonpregnant women</measure>
    <time_frame>1 month after booster vaccination</time_frame>
    <description>Describe GBS serotype-specific IgG GMCs measured 1 month after a booster vaccination in nonpregnant women</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 3 months after a booster vaccination in nonpregnant women</measure>
    <time_frame>3 months after booster vaccination</time_frame>
    <description>Describe GBS serotype-specific IgG GMCs measured 3 months after a booster vaccination in nonpregnant women</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 6 months after a booster vaccination in nonpregnant women</measure>
    <time_frame>6 months after booster vaccination</time_frame>
    <description>Describe GBS serotype-specific IgG GMCs measured 6 months after a booster vaccination in nonpregnant women</description>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">1207</enrollment>
  <condition>Group B Streptococcus Infections</condition>
  <arm_group>
    <arm_group_label>Stage 1 - Highest dose formulation a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 1 - Highest dose formulation b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 - Lowest dose formulation a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multivalent group B streptococcus vaccine - Stage 2 Pregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 - Lowest dose formulation b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multivalent group B streptococcus vaccine - Stage 2 Pregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 - Middle dose formulation a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multivalent group B streptococcus vaccine - Stage 2 Pregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 - Middle dose formulation b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multivalent group B streptococcus vaccine - Stage 2 Pregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 - Highest dose formulation a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multivalent group B streptococcus vaccine - Stage 2 Pregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 - Highest dose formulation b</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multivalent group B streptococcus vaccine - Stage 2 Pregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 3 - Selected dose and formulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Multivalent group B streptococcus vaccine - Stage 3 Pregnant women</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 1 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline control</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 3 Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline control</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Multivalent Group B streptococcus vaccine</intervention_name>
    <description>Various formulations at three dose levels</description>
    <arm_group_label>Stage 1 - Highest dose formulation a</arm_group_label>
    <arm_group_label>Stage 1 - Highest dose formulation b</arm_group_label>
    <arm_group_label>Stage 2 - Highest dose formulation a</arm_group_label>
    <arm_group_label>Stage 2 - Highest dose formulation b</arm_group_label>
    <arm_group_label>Stage 2 - Lowest dose formulation a</arm_group_label>
    <arm_group_label>Stage 2 - Lowest dose formulation b</arm_group_label>
    <arm_group_label>Stage 2 - Middle dose formulation a</arm_group_label>
    <arm_group_label>Stage 2 - Middle dose formulation b</arm_group_label>
    <arm_group_label>Stage 3 - Selected dose and formulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Saline control</description>
    <arm_group_label>Stage 1 Placebo</arm_group_label>
    <arm_group_label>Stage 2 Placebo</arm_group_label>
    <arm_group_label>Stage 3 Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria Stage 1 Nonpregnant Women:&#xD;
&#xD;
          -  Healthy nonpregnant females 18 to 40 years of age at enrollment who are determined by&#xD;
             medical history, physical examination, and clinical judgment of the investigator to be&#xD;
             eligible for inclusion in the study.&#xD;
&#xD;
          -  Negative urine pregnancy test at Visit 1 (prior to vaccination).&#xD;
&#xD;
          -  Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B&#xD;
             virus (HBV) infection at screening.&#xD;
&#xD;
        Inclusion Criteria Stage 1 Booster Vaccination:&#xD;
&#xD;
          -  Participant must have received investigational product at Visit 1.&#xD;
&#xD;
          -  Healthy nonpregnant female determined by medical history, physical examination, and&#xD;
             clinical judgment of the investigator to be eligible for booster vaccination and&#xD;
             received investigational product at Visit 1.&#xD;
&#xD;
          -  Negative urine pregnancy test at Visit 6 (prior to vaccination).&#xD;
&#xD;
          -  Documented negative HIV, hepatitis C virus (HCV), and acute or chronic hepatitis B&#xD;
             virus (HBV) infection at screening.&#xD;
&#xD;
        Inclusion Criteria Stage 2 and 3 Maternal Participants:&#xD;
&#xD;
          -  Healthy females &gt;=18 and &lt;=40 years of age who are &gt;=27 0/7 (Stage 2) or &gt;=24 0/7&#xD;
             (Stage 3) to &lt;=35 6/7 weeks' gestation on the day of planned vaccination, with an&#xD;
             uncomplicated, singleton pregnancy, and at no increased risk for complications and no&#xD;
             significant fetal abnormalities observed on ultrasound performed at any time prior to&#xD;
             study entry and/or at the screening visit.&#xD;
&#xD;
          -  Documented negative HIV antibody, HBV surface antigen, HCV antibody, and syphilis&#xD;
             tests at screening.&#xD;
&#xD;
        Inclusion Criteria Stage 2 and 3 Infant Participants:&#xD;
&#xD;
        Evidence of a signed and dated ICD signed by the parent(s). Parent(s) willing and able to&#xD;
        comply with scheduled visits, investigational plan, laboratory tests, and other study&#xD;
        procedures.&#xD;
&#xD;
        Exclusion Criteria Stage 1 Nonpregnant Women:&#xD;
&#xD;
          -  Other medical or psychiatric condition including recent (within the past year) or&#xD;
             active suicidal ideation or behavior or laboratory abnormality that may increase the&#xD;
             risk associated with study participation or investigational product administration or&#xD;
             may interfere with the interpretation of study results and, in the judgment of the&#xD;
             investigator, would make the participant inappropriate for entry into this study.&#xD;
&#xD;
          -  History of severe adverse reaction associated with a vaccine and/or severe allergic&#xD;
             reaction (eg, anaphylaxis) to any component of the investigational product or any&#xD;
             diphtheria toxoid-containing or CRM197 containing vaccine.&#xD;
&#xD;
          -  History of microbiologically proven invasive disease caused by GBS (S agalactiae).&#xD;
&#xD;
          -  Previous vaccination with any licensed or investigational GBS vaccine (other than GBS6&#xD;
             received as a primary vaccination at Visit 1), or planned receipt during the&#xD;
             participant's participation in the study (through the last blood draw).&#xD;
&#xD;
        Exclusion criteria Stage 2 and 3 Maternal Participants:&#xD;
&#xD;
          -  Other medical or psychiatric condition including recent (within the past year) or&#xD;
             active suicidal ideation or behavior or laboratory abnormality that may increase the&#xD;
             risk associated with study participation or investigational product administration or&#xD;
             may interfere with the interpretation of study results and, in the judgment of the&#xD;
             investigator, would make the participant inappropriate for entry into this study.&#xD;
&#xD;
          -  History of severe adverse reaction associated with a vaccine and/or severe allergic&#xD;
             reaction (eg, anaphylaxis) to any component of the investigational product or any&#xD;
             diphtheria toxoid-containing or CRM197 containing vaccine.&#xD;
&#xD;
          -  History of microbiologically proven invasive disease caused by GBS (S agalactiae).&#xD;
&#xD;
          -  Previous vaccination with any licensed or investigational group B streptococcus&#xD;
             vaccine, or planned receipt during the participant's participation in the study&#xD;
             (through the last blood draw).&#xD;
&#xD;
          -  Prepregnancy body mass index (BMI) of ≥40 kg/m2. If prepregnancy BMI is not available,&#xD;
             the BMI at the time of the first obstetric visit during the current pregnancy may be&#xD;
             used.&#xD;
&#xD;
          -  A prior history of or current pregnancy complications or abnormalities that will&#xD;
             increase the risk associated with the participant's participation.&#xD;
&#xD;
          -  Major illness of the mother or conditions of the fetus that, in the investigator's&#xD;
             judgment, will substantially increase the risk associated with the participant's&#xD;
             participation in, and completion of, the study or could preclude the evaluation of the&#xD;
             participant's response.&#xD;
&#xD;
        Exclusion criteria Stage 2 and 3 Infant Participants:&#xD;
&#xD;
        Infant who is a direct descendant (eg, child or grandchild) of the study personnel.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MedPharmics, LLC</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedPharmics, LLC</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chemidox Clinical Trials Inc.</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chemidox Clinical Trials Inc</name>
      <address>
        <city>Lancaster</city>
        <state>California</state>
        <zip>93534</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emerson Clinical Research Institute</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Prime</name>
      <address>
        <city>Idaho Falls</city>
        <state>Idaho</state>
        <zip>83404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Prime Rexburg</name>
      <address>
        <city>Rexburg</city>
        <state>Idaho</state>
        <zip>83440</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lakeview Regional Medical Center</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedPharmics</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Tammany Parish Hospital</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velocity Clinical Research, Covington</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Oaks Medical Center</name>
      <address>
        <city>Hammond</city>
        <state>Louisiana</state>
        <zip>70403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Oaks Obstetrics &amp; Gynecology</name>
      <address>
        <city>Hammond</city>
        <state>Louisiana</state>
        <zip>70403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedPharmics, LLC (Recruitment Call Center)</name>
      <address>
        <city>Lafayette</city>
        <state>Louisiana</state>
        <zip>70508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedPharmics, LLC</name>
      <address>
        <city>Lafayette</city>
        <state>Louisiana</state>
        <zip>70508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedPharmics, LLC</name>
      <address>
        <city>Slidell</city>
        <state>Louisiana</state>
        <zip>70458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velocity Clinical Research, Slidell</name>
      <address>
        <city>Slidell</city>
        <state>Louisiana</state>
        <zip>70458</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boeson Research</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Hospital</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Birth Center</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Hastings</city>
        <state>Nebraska</state>
        <zip>68901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frontier Pediatric Care (Follow-Up Visits for Infant Participants)</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68506</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bryan Women's Care Physicians (Maternal Visits &amp; Obstetric Exams)</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Be Well Clinical Studies</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research, LLC</name>
      <address>
        <city>Norfolk</city>
        <state>Nebraska</state>
        <zip>68701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedPharmics, LLC</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Velocity Clinical Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lowcountry Women's Specialists</name>
      <address>
        <city>Summerville</city>
        <state>South Carolina</state>
        <zip>29485</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Summerville Medical Center</name>
      <address>
        <city>Summerville</city>
        <state>South Carolina</state>
        <zip>29485</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Coastal Pediatric Research</name>
      <address>
        <city>Summerville</city>
        <state>South Carolina</state>
        <zip>29486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Davids Medical Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekton Research, Inc</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sentara Leigh Hospital</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Group for Women</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tidewater Physicians for Women</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wits Reproductive Health and HIV Institute</name>
      <address>
        <city>Johannesburg</city>
        <state>Gauteng</state>
        <zip>2001</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Respiratory and Meningeal Pathogens Research Unit (RMPRU)</name>
      <address>
        <city>Soweto</city>
        <state>Gauteng</state>
        <zip>1862</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Empilweni Services and Research Unit (ESRU)</name>
      <address>
        <city>Coronationville</city>
        <state>Johannesburg</state>
        <zip>2093</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlotte Maxeke Johannesburg Academic Hospital</name>
      <address>
        <city>Parktown</city>
        <state>Johannesburg</state>
        <zip>2196</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khayelitsha Hospital</name>
      <address>
        <city>Khayelitsha</city>
        <state>Western CAPE</state>
        <zip>7784</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Michael Mapongwana Community Health Centre</name>
      <address>
        <city>Khayelitsha</city>
        <state>Western CAPE</state>
        <zip>7784</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FAMCRU</name>
      <address>
        <city>Parow Valley</city>
        <state>Western CAPE</state>
        <zip>7505</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St George's University Hospitals NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <state>Tooting</state>
        <zip>SW17 0QT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>South Africa</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=C1091002</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>July 25, 2023</last_update_submitted>
  <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Streptococcal Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03765073
org study id: C1091002
secondary id: 2020-005074-96
nct id: NCT03765073
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
Phase 1/2, randomized, placebo-controlled, observer-blinded study will evaluate the safety,
      tolerability and immunogenicity of the investigational multivalent group B streptococcus
      vaccine administered at one dose level (various formulations) in healthy nonpregnant women
      (various formulations at one dose level), and then in healthy pregnant women (various
      formulations at three dose levels), and finally in healthy pregnant women at a selected dose
      level/formulation.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the participant, will be blinded.
measure: Percentages of nonpregnant women reporting prompted local reactions within 7 days following primary and booster doses of investigational product (pain at the injection site, redness, and swelling).
time frame: Day 7
description: Describe prompted local reactions for nonpregnant women following investigational product administration.
measure: Percentages of nonpregnant women reporting prompted systemic events within 7 days following primary and booster doses of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).
time frame: Day 7
description: Describe prompted systemic events for nonpregnant women following investigational product administration.
measure: Percentages of nonpregnant women reporting adverse events (AEs) through 1 month following administration of the primary and booster doses of investigational product.
time frame: 1 month following administration of investigational product
description: Describe AEs for nonpregnant women occurring through 1 month following administration of investigational product.
measure: Percentages of nonpregnant women reporting SAEs through 6 months following administration of the primary dose of investigational product.
time frame: 6 months following administration of investigational product
description: Describe SAEs for nonpregnant women through 6 months following administration of investigational product.
measure: Percentages of sentinel-cohort maternal participants (Stage 2 only) with clinical laboratory abnormalities following administration of investigational product at the 2-week follow-up visit.
time frame: 2 weeks following administration of investigational product
description: Describe clinical laboratory abnormalities for maternal participants (Stage 2 only) following administration of investigational product at 2-week follow-up visit.
measure: Percentages of maternal participants reporting prompted local reactions within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).
time frame: Day 7
description: Describe prompted local reactions for maternal participants within 7 days following administration of investigational product (pain at the injection site, redness, and swelling).
measure: Percentages of maternal participants reporting prompted systemic events within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).
time frame: Day 7
description: Describe prompted systemic events for maternal participants within 7 days following administration of investigational product (fever, nausea/vomiting, diarrhea, headache, fatigue/tiredness, muscle pain, and joint pain).
measure: Percentages of maternal participants reporting AEs through 1 month after administration of investigational product.
time frame: 1 month after administration of investigational product
description: Describe AEs through 1 month after administration of investigational product.
measure: Percentages of maternal participants with SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) throughout the study (Visit 1 through the 12-month postdelivery study visit).
time frame: 12 months after delivery
description: Describe SAEs, MAEs, and obstetric complications (prepartum, intrapartum, and postpartum) for maternal participants throughout the study (Visit 1 through the 12-month postdelivery study visit).
measure: Percentages of maternal participants with each delivery outcome (live birth, delivery mode).
time frame: Delivery
description: Describe delivery outcomes (live birth, delivery mode) for maternal participants.
measure: Percentages of infant participants with specific birth outcomes.
time frame: Birth
description: Describe specific birth outcomes for infant participants.
measure: Percentages of infant participants with AEs from birth to 6 weeks of age.
time frame: 6 weeks of age
description: Describe AEs for infant participants from birth to 6 weeks of age.
measure: Percentages of infant participants with SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs through 12 months of age.
time frame: 12 months of age
description: Describe SAEs, AEs of special interest (major congenital anomalies, developmental delay, and suspected or confirmed GBS infection), and MAEs for infant participants through 12 months of age.
measure: Percentages of nonpregnant women reporting SAEs approximately 7 to 12 months following the booster doses of investigational product.
time frame: 7 to 12 months following administration of investigational product
description: Describe SAEs for nonpregnant women 7 to 12 months following administration of investigational product.
measure: Percentages of nonpregnant women reporting medically attended adverse events (MAEs) through 6 months following administration of the primary dose of investigational product.
time frame: 6 months following administration of investigational product
description: Describe MAEs for nonpregnant women through 6 months following administration of investigational product.
measure: Percentages of nonpregnant women reporting medically attended adverse events (MAEs) approximately 7 to 12 months following the booster doses of investigational product.
time frame: 7 to 12 months following administration of investigational product
description: Describe MAEs for nonpregnant women 7 to 12 months following administration of investigational product.
measure: Group B streptococcus (GBS) serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.
time frame: 1 month after vaccination
description: Describe GBS serotype-specific IgG geometric mean concentrations (GMCs) 1 month after vaccination in nonpregnant women.
measure: GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal participants.
time frame: 2 weeks after vaccination
description: Describe GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal participants.
measure: GBS serotype-specific IgG GMCs in infant participants measured at birth.
time frame: Birth
description: Describe GBS serotype-specific IgG GMCs in infant participants measured at birth.
measure: GBS serotype-specific OPA GMTs in infant participants measured at birth.
time frame: Birth
description: Describe GBS serotype-specific OPA GMTs in infant participants measured at birth.
measure: GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal participants.
time frame: 1 month after vaccination
description: Describe GBS serotype-specific IgG GMCs measured at 1 month after vaccination in maternal participants.
measure: GBS serotype-specific IgG GMCs measured at delivery in maternal participants.
time frame: Delivery
description: Describe GBS serotype-specific IgG GMCs measured at delivery in maternal participants.
measure: GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal participants.
time frame: 1 month after vaccination
description: Describe GBS serotype-specific OPA GMTs measured at 1 month after vaccination in maternal participants.
measure: GBS serotype-specific OPA GMTs measured at delivery in maternal participants.
time frame: Delivery
description: Describe GBS serotype-specific OPA GMTs measured at delivery in maternal participants.
measure: GBS serotype-specific IgG geometric mean concentrations (GMCs) measured before a booster vaccination in nonpregnant women
time frame: Before booster vaccination
description: Describe GBS serotype-specific IgG GMCs measured before a booster vaccination in nonpregnant women
measure: GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 1 month after a booster vaccination in nonpregnant women
time frame: 1 month after booster vaccination
description: Describe GBS serotype-specific IgG GMCs measured 1 month after a booster vaccination in nonpregnant women
measure: GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 3 months after a booster vaccination in nonpregnant women
time frame: 3 months after booster vaccination
description: Describe GBS serotype-specific IgG GMCs measured 3 months after a booster vaccination in nonpregnant women
measure: GBS serotype-specific IgG geometric mean concentrations (GMCs) measured 6 months after a booster vaccination in nonpregnant women
time frame: 6 months after booster vaccination
description: Describe GBS serotype-specific IgG GMCs measured 6 months after a booster vaccination in nonpregnant women
arm group label: Stage 1 - Highest dose formulation a
arm group type: Experimental
description: Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
arm group label: Stage 1 - Highest dose formulation b
arm group type: Experimental
description: Multivalent group B streptococcus vaccine - Stage 1 Nonpregnant women
arm group label: Stage 2 - Lowest dose formulation a
arm group type: Experimental
description: Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
arm group label: Stage 2 - Lowest dose formulation b
arm group type: Experimental
description: Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
arm group label: Stage 2 - Middle dose formulation a
arm group type: Experimental
description: Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
arm group label: Stage 2 - Middle dose formulation b
arm group type: Experimental
description: Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
arm group label: Stage 2 - Highest dose formulation a
arm group type: Experimental
description: Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
arm group label: Stage 2 - Highest dose formulation b
arm group type: Experimental
description: Multivalent group B streptococcus vaccine - Stage 2 Pregnant women
arm group label: Stage 3 - Selected dose and formulation
arm group type: Experimental
description: Multivalent group B streptococcus vaccine - Stage 3 Pregnant women
arm group label: Stage 1 Placebo
arm group type: Placebo Comparator
description: Saline control
arm group label: Stage 2 Placebo
arm group type: Placebo Comparator
description: Saline control
arm group label: Stage 3 Placebo
arm group type: Placebo Comparator
description: Saline control
intervention type: Biological
intervention name: Multivalent Group B streptococcus vaccine
description: Various formulations at three dose levels
arm group label: Stage 1 - Highest dose formulation a
arm group label: Stage 1 - Highest dose formulation b
arm group label: Stage 2 - Highest dose formulation a
arm group label: Stage 2 - Highest dose formulation b
arm group label: Stage 2 - Lowest dose formulation a
arm group label: Stage 2 - Lowest dose formulation b
arm group label: Stage 2 - Middle dose formulation a
arm group label: Stage 2 - Middle dose formulation b
arm group label: Stage 3 - Selected dose and formulation
intervention type: Biological
intervention name: Placebo
description: Saline control
arm group label: Stage 1 Placebo
arm group label: Stage 2 Placebo
arm group label: Stage 3 Placebo
criteria: 
gender: All
minimum age: 0 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: South Africa
country: United Kingdom
country: United States
url: https://pmiform.com/clinical-trial-info-request?StudyID=C1091002
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Streptococcal Infections
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests