<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/NCT01692886</url>
  </required_header>
  <id_info>
    <org_study_id>B1851015</org_study_id>
    <secondary_id>6096A1-3019</secondary_id>
    <nct_id>NCT01692886</nct_id>
  </id_info>
  <brief_title>A Study Evaluating 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) In Healthy Infants In China</brief_title>
  <official_title>A Phase 3, Randomized, Active-controlled Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13vPnC Vaccine Compared With a 7vPnC in Healthy Infants in China</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal&#xD;
      serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured&#xD;
      1 month after the infant series, and to evaluate the acceptability of the safety profile of&#xD;
      13vPnC as measured by the incidence rates of local reactions, systemic events and adverse&#xD;
      events.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2.</measure>
    <time_frame>1 month after the infant series (6 Months of age)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3.</measure>
    <time_frame>1 month after the infant series (7 Months of age)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2.</measure>
    <time_frame>1 month after the infant series (6 Months of age)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3.</measure>
    <time_frame>1 month after the infant series (7 Months of age)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Reporting Adverse Events in Group 1 and Group 2.</measure>
    <time_frame>Approximately 16 months from the participation into the study to the end of study</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Reporting Adverse Events in Group 3 and Group 4.</measure>
    <time_frame>Approximately 16 months from the participation into study to the end of study</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.</measure>
    <time_frame>Seven days after each pneumococcal vaccination dose within the period up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.</measure>
    <time_frame>Seven days after each pneumococcal vaccination dose within the period up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.</measure>
    <time_frame>Seven days after each pneumococcal vaccination dose within the period up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.</measure>
    <time_frame>Seven days after each pneumococcal vaccination dose within the period up to 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2.</measure>
    <time_frame>1 month after the infant series (6 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3.</measure>
    <time_frame>1 month after the infant series (7 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2.</measure>
    <time_frame>1 month after the infant series (6 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3.</measure>
    <time_frame>1 month after the infant series (7 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3.</measure>
    <time_frame>1 month after the toddler dose (13 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 2 and Group 3.</measure>
    <time_frame>1 month after the toddler dose (13 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3.</measure>
    <time_frame>1 month after the toddler dose (13 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 4.</measure>
    <time_frame>1 month after the infant series (6 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4.</measure>
    <time_frame>1 month after the infant series (6 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4.</measure>
    <time_frame>1 month after the toddler dose (13 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 4.</measure>
    <time_frame>1 month after the infant series (6 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 4.</measure>
    <time_frame>1 month after the toddler dose (13 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4.</measure>
    <time_frame>1 month after the infant series (6 Months of age)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4.</measure>
    <time_frame>1 month after the toddler dose (13 Months of age)</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1674</enrollment>
  <condition>Pneumococcal Infection</condition>
  <arm_group>
    <arm_group_label>7vPnC (3-, 4-, 5-, 12-Month)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>13vPnC (3-, 4-, 5-, 12-Month)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>13vPnC (2-, 4-, 6-, 12-Month)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>13vPnC (3-, 5-, 12-Month)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>7-valent Pneumococcal Conjugate Vaccine</intervention_name>
    <description>suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively</description>
    <arm_group_label>7vPnC (3-, 4-, 5-, 12-Month)</arm_group_label>
    <other_name>7vPnC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>13-valent Pnumococcal Conjugate vaccine</intervention_name>
    <description>suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively</description>
    <arm_group_label>13vPnC (3-, 4-, 5-, 12-Month)</arm_group_label>
    <other_name>13vPnC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>13-valent Pnumococcal Conjugate vaccine</intervention_name>
    <description>suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 2-Month Visit, 4-Month Visit, 6-Month Visit, and 12-Month Visit, respectively</description>
    <arm_group_label>13vPnC (2-, 4-, 6-, 12-Month)</arm_group_label>
    <other_name>13vPnC</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>13-valent Pnumococcal Conjugate vaccine</intervention_name>
    <description>suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively</description>
    <arm_group_label>13vPnC (3-, 5-, 12-Month)</arm_group_label>
    <other_name>13vPnC</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 42 to 77 days (approximately 2 months) at the time of enrollment.&#xD;
&#xD;
          2. Healthy infant as determined by medical history, physical examination, and judgment of&#xD;
             the investigator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous vaccination with licensed or investigational pneumococcal vaccine.&#xD;
&#xD;
          2. A previous anaphylactic reaction to any vaccine or vaccine-related component.&#xD;
&#xD;
          3. Contraindication to vaccination with pneumococcal vaccines.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>42 Days</minimum_age>
    <maximum_age>77 Days</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>Jiangsu Province Guanyun County Center for Disease prevention and Control</name>
      <address>
        <city>Guanyun County,</city>
        <state>Jiangsu</state>
        <zip>222200</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hongze County Center for Disease prevention and Control</name>
      <address>
        <city>Huaian City</city>
        <state>Jiangsu</state>
        <zip>223100</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Huaiyin District Center for Disease prevention and Control</name>
      <address>
        <city>Huaian City</city>
        <state>Jiangsu</state>
        <zip>223300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Lianshui County Center for Disease prevention and Control</name>
      <address>
        <city>Lianshui County</city>
        <state>Jiangsu</state>
        <zip>223400</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1851015&amp;StudyName=A%20Study%20Evaluating%2013-Valent%20Pneumococcal%20Conjugate%20Vaccine%20%2813vPnC%29%20In%20Healthy%20Infants%20In%20China</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>13vPnC</keyword>
  <keyword>7vPnC</keyword>
  <keyword>Healthy subjects</keyword>
  <keyword>China</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumococcal Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
    <mesh_term>Heptavalent Pneumococcal Conjugate Vaccine</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>October 29, 2015</submitted>
    <returned>December 1, 2015</returned>
  </pending_results>
  <!-- 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/NCT01692886
org study id: B1851015
secondary id: 6096A1-3019
nct id: NCT01692886
lead sponsor: 
has dmc: Yes
This study is primarily designed to evaluate the IgG immune responses to the 13 pneumococcal
      serotypes induced by 13vPnC compared with the immune responses induced by 7vPnC when measured
      1 month after the infant series, and to evaluate the acceptability of the safety profile of
      13vPnC as measured by the incidence rates of local reactions, systemic events and adverse
      events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 1 And Group 2.
time frame: 1 month after the infant series (6 Months of age)
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 3.
time frame: 1 month after the infant series (7 Months of age)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 1 and Group 2.
time frame: 1 month after the infant series (6 Months of age)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 3.
time frame: 1 month after the infant series (7 Months of age)
measure: Percentage of Participants Reporting Adverse Events in Group 1 and Group 2.
time frame: Approximately 16 months from the participation into the study to the end of study
measure: Percentage of Participants Reporting Adverse Events in Group 3 and Group 4.
time frame: Approximately 16 months from the participation into study to the end of study
measure: Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
time frame: Seven days after each pneumococcal vaccination dose within the period up to 12 months
measure: Percentage of Participants Reporting Pre-Specified Local Reactions In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
time frame: Seven days after each pneumococcal vaccination dose within the period up to 12 months
measure: Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 1 and Group 2.
time frame: Seven days after each pneumococcal vaccination dose within the period up to 12 months
measure: Percentage of Participants Reporting Pre-Specified Systemic Events (Including The Use Of Antipyretic Medication) In the 7 Days After Each Pneumococcal Vaccination in Group 3 and Group 4.
time frame: Seven days after each pneumococcal vaccination dose within the period up to 12 months
measure: Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 1 And Group 2.
time frame: 1 month after the infant series (6 Months of age)
measure: Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 3.
time frame: 1 month after the infant series (7 Months of age)
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 1 and Group 2.
time frame: 1 month after the infant series (6 Months of age)
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 3.
time frame: 1 month after the infant series (7 Months of age)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 2 and Group 3.
time frame: 1 month after the toddler dose (13 Months of age)
measure: Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 2 and Group 3.
time frame: 1 month after the toddler dose (13 Months of age)
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 2 and Group 3.
time frame: 1 month after the toddler dose (13 Months of age)
measure: Percentage of Participants Achieving Serotype-specific Pneumococcal IgG Antibody Level ≥0.35 mcg/mL 1 Month After the Infant Series in Group 4.
time frame: 1 month after the infant series (6 Months of age)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series in Group 4.
time frame: 1 month after the infant series (6 Months of age)
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose in Group 4.
time frame: 1 month after the toddler dose (13 Months of age)
measure: Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Infant Series in Group 4.
time frame: 1 month after the infant series (6 Months of age)
measure: Percentage of Participants In A Subset Achieving Serotype-specific Opsonophagocytic Activity (OPA) Titer ≥ Lower Limit Of Quantitation (LLOQ) 1 Month After the Toddler Dose in Group 4.
time frame: 1 month after the toddler dose (13 Months of age)
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Infant Series in Group 4.
time frame: 1 month after the infant series (6 Months of age)
measure: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titer (GMT) 1 Month After the Toddler Dose in Group 4.
time frame: 1 month after the toddler dose (13 Months of age)
arm group label: 7vPnC (3-, 4-, 5-, 12-Month)
arm group type: Active Comparator
arm group label: 13vPnC (3-, 4-, 5-, 12-Month)
arm group type: Experimental
arm group label: 13vPnC (2-, 4-, 6-, 12-Month)
arm group type: Experimental
arm group label: 13vPnC (3-, 5-, 12-Month)
arm group type: Experimental
intervention type: Biological
intervention name: 7-valent Pneumococcal Conjugate Vaccine
description: suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
arm group label: 7vPnC (3-, 4-, 5-, 12-Month)
other name: 7vPnC
intervention type: Biological
intervention name: 13-valent Pnumococcal Conjugate vaccine
description: suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
arm group label: 13vPnC (3-, 4-, 5-, 12-Month)
other name: 13vPnC
intervention type: Biological
intervention name: 13-valent Pnumococcal Conjugate vaccine
description: suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 2-Month Visit, 4-Month Visit, 6-Month Visit, and 12-Month Visit, respectively
arm group label: 13vPnC (2-, 4-, 6-, 12-Month)
other name: 13vPnC
intervention type: Biological
intervention name: 13-valent Pnumococcal Conjugate vaccine
description: suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
arm group label: 13vPnC (3-, 5-, 12-Month)
other name: 13vPnC
criteria: 
gender: All
minimum age: 42 Days
maximum age: 77 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
facility: 
country: China
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1851015&StudyName=A%20Study%20Evaluating%2013-Valent%20Pneumococcal%20Conjugate%20Vaccine%20%2813vPnC%29%20In%20Healthy%20Infants%20In%20China
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Pneumococcal Infections
mesh term: Vaccines
mesh term: Heptavalent Pneumococcal Conjugate Vaccine
submitted: October 29, 2015
returned: December 1, 2015