<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/NCT01700127</url>
  </required_header>
  <id_info>
    <org_study_id>SAS/RCN/201208</org_study_id>
    <nct_id>NCT01700127</nct_id>
  </id_info>
  <brief_title>Predictors of Poor Immune Response to Rotavirus Vaccine in Infants</brief_title>
  <acronym>PPIR</acronym>
  <official_title>Predictors of Poor Immune Response to Rotavirus Vaccine in Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Society for Applied Studies</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Christian Medical College, Vellore, India</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Norwegian Institute of Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Society for Applied Studies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This will be a randomized study with the primary objective of assessing the impact of&#xD;
      withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.&#xD;
&#xD;
      Enrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14&#xD;
      weeks. The subjects will be randomized into one of the two study arms. In one of the group&#xD;
      caregivers will be advised to breastfeed immediately prior to and after each dose of the&#xD;
      vaccine while in the other group caregivers will be advised to withhold breastfeeding for 30&#xD;
      minutes before and after each dose of the vaccine. The other childhood vaccines i.e. OPV and&#xD;
      Pentavalent will be administered at least 30 minutes after administration of Rotarix®, The&#xD;
      enrolled subjects will be followed up for 4 weeks after the 2nd dose of Rotarix®.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infants ≤7 weeks and pregnant women will be identified through a household survey.Families of&#xD;
      infants aged 6-7 weeks will be called to the study clinic for consenting, screening and&#xD;
      enrollment.All enrolled subjects will be administered 2 doses of Rotarix® at 6 to 7 weeks and&#xD;
      at 10-14 weeks of age. Other childhood vaccines will also be offered.&#xD;
&#xD;
      At enrollment, a blood specimen and breast milk specimen will be obtained from the mother and&#xD;
      a blood, salivary and stool specimens will be obtained from the subject before administering&#xD;
      the Rotarix® vaccine.&#xD;
&#xD;
      At the time of the 2nd administration, a breast milk specimen will be obtained from the&#xD;
      mother and a salivary specimen will be obtained from the subject before administering the&#xD;
      Rotarix® vaccine. At 28 days (±) 5 after the 2nd dose of Rotarix® vaccine, a blood, salivary&#xD;
      and stool specimen will be obtained from the subject.&#xD;
&#xD;
      Whenever the family comes to the study clinic at 6-7 weeks, consent will be administered and&#xD;
      a clinical examination conducted.If the family is willing for the mother and the child to be&#xD;
      part of the study and the child meets the eligibility criteria, the child will be enrolled.&#xD;
&#xD;
      Depending on the group allocation the mothers will be advised to withhold or encourage&#xD;
      breastfeeding for 30 minutes before and after receipt of Rotarix®.&#xD;
&#xD;
      subjects will be observed for 30 minutes after receipt of the vaccines to assess for&#xD;
      immediate adverse events.&#xD;
&#xD;
      All minor illnesses that do not require hospital referral will be managed by the study&#xD;
      physician using current practices.&#xD;
&#xD;
      All hospitalizations and deaths will be reported and reviewed by an Independent Safety&#xD;
      Monitor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</primary_completion_date>
  <phase>N/A</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®.</measure>
    <time_frame>14-18 weeks of age</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Concentration of anti-VP6 antibodies in saliva of subjects before the first and second dose of Rotarix®. Proportion of subjects with enteric pathogens detected in stools. Vitamin D status of subjects enrolled in the study.</measure>
    <time_frame>14-18 weeks of age</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Concentration of anti-VP6 antibodies in subjects and maternal serum at baseline and in subjects 4 weeks after the second dose of Rotarix®. Geometric mean titers of anti-VP6 IgG antibodies in maternal serum at baseline</measure>
    <time_frame>upto 14-18 weeks of age</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">400</enrollment>
  <condition>Innate Immune Response</condition>
  <arm_group>
    <arm_group_label>Breastfeeding</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Breastfeeding Encouraged</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breastfeeding Withheld</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Breastfeeding Withheld</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Breastfeeding</intervention_name>
    <description>breastfeeding encouraged versus withheld</description>
    <arm_group_label>Breastfeeding</arm_group_label>
    <arm_group_label>Breastfeeding Withheld</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. At least one parent(s) or legally acceptable representative's consent for&#xD;
             participation and are able to understand study procedures&#xD;
&#xD;
          2. Subjects aged 6 to 7 weeks at recruitment&#xD;
&#xD;
          3. No plans to move in the next 4 months&#xD;
&#xD;
          4. Weight for age not ≤ -3 SD of WHO child growth standards&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Infant not breastfed&#xD;
&#xD;
          2. Administration of rotavirus vaccine in the past&#xD;
&#xD;
          3. Known immunodeficiency disease, including HIV infection in the subject or the mother&#xD;
&#xD;
          4. Known chronic enteric disease&#xD;
&#xD;
          5. Diarrhea on the day of enrollment (temporary exclusion)&#xD;
&#xD;
          6. Any illness requiring hospitalization (temporary exclusion)&#xD;
&#xD;
          7. Any other conditions which in the judgment of the investigator warrant exclusion (e.g.&#xD;
             no exclusion criteria but seems 'ill', investigators suspects neglect)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Weeks</minimum_age>
    <maximum_age>7 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Temsunaro R Chandola, MBBS MSc Epi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Scientist, SAS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nita Bhandari, MBBS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Joint Director, SAS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sunita Taneja, MBBS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Research Coordinator, SAS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gagandeep Kang, MD PhD FRCPath</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor and Head,The Wellcome Trust Research Laboratory,Christian Medical College</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tor A Strand, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Adjunct Professor, CIH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre for Health Research and Development Society for Applied Studies</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110016</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>June 2013</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>June 25, 2013</last_update_submitted>
  <last_update_submitted_qc>June 25, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 26, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>immune response</keyword>
  <keyword>infants</keyword>
  <keyword>rotavirus vaccine</keyword>
  <!-- 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/NCT01700127
org study id: SAS/RCN/201208
nct id: NCT01700127
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This will be a randomized study with the primary objective of assessing the impact of
      withholding versus encouraging breastfeeding on the immunogenicity of Rotarix® in infants.

      Enrolled subjects will all be administered Rotarix®, at ages 6 to 7 weeks, and at10 -14
      weeks. The subjects will be randomized into one of the two study arms. In one of the group
      caregivers will be advised to breastfeed immediately prior to and after each dose of the
      vaccine while in the other group caregivers will be advised to withhold breastfeeding for 30
      minutes before and after each dose of the vaccine. The other childhood vaccines i.e. OPV and
      Pentavalent will be administered at least 30 minutes after administration of Rotarix®, The
      enrolled subjects will be followed up for 4 weeks after the 2nd dose of Rotarix®.
Infants ≤7 weeks and pregnant women will be identified through a household survey.Families of
      infants aged 6-7 weeks will be called to the study clinic for consenting, screening and
      enrollment.All enrolled subjects will be administered 2 doses of Rotarix® at 6 to 7 weeks and
      at 10-14 weeks of age. Other childhood vaccines will also be offered.

      At enrollment, a blood specimen and breast milk specimen will be obtained from the mother and
      a blood, salivary and stool specimens will be obtained from the subject before administering
      the Rotarix® vaccine.

      At the time of the 2nd administration, a breast milk specimen will be obtained from the
      mother and a salivary specimen will be obtained from the subject before administering the
      Rotarix® vaccine. At 28 days (±) 5 after the 2nd dose of Rotarix® vaccine, a blood, salivary
      and stool specimen will be obtained from the subject.

      Whenever the family comes to the study clinic at 6-7 weeks, consent will be administered and
      a clinical examination conducted.If the family is willing for the mother and the child to be
      part of the study and the child meets the eligibility criteria, the child will be enrolled.

      Depending on the group allocation the mothers will be advised to withhold or encourage
      breastfeeding for 30 minutes before and after receipt of Rotarix®.

      subjects will be observed for 30 minutes after receipt of the vaccines to assess for
      immediate adverse events.

      All minor illnesses that do not require hospital referral will be managed by the study
      physician using current practices.

      All hospitalizations and deaths will be reported and reviewed by an Independent Safety
      Monitor.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Proportion of subjects who seroconvert as measured by a 4-fold rise in serum anti-VP6 IgA antibodies between baseline and 4 weeks after the second dose of Rotarix®.
time frame: 14-18 weeks of age
measure: Concentration of anti-VP6 antibodies in saliva of subjects before the first and second dose of Rotarix®. Proportion of subjects with enteric pathogens detected in stools. Vitamin D status of subjects enrolled in the study.
time frame: 14-18 weeks of age
measure: Concentration of anti-VP6 antibodies in subjects and maternal serum at baseline and in subjects 4 weeks after the second dose of Rotarix®. Geometric mean titers of anti-VP6 IgG antibodies in maternal serum at baseline
time frame: upto 14-18 weeks of age
arm group label: Breastfeeding
arm group type: Other
description: Breastfeeding Encouraged
arm group label: Breastfeeding Withheld
arm group type: Active Comparator
description: Breastfeeding Withheld
intervention type: Other
intervention name: Breastfeeding
description: breastfeeding encouraged versus withheld
arm group label: Breastfeeding
arm group label: Breastfeeding Withheld
criteria: 
gender: All
minimum age: 6 Weeks
maximum age: 7 Weeks
healthy volunteers: Accepts Healthy Volunteers
last name: Temsunaro R Chandola, MBBS MSc Epi
role: Principal Investigator
affiliation: Research Scientist, SAS
last name: Nita Bhandari, MBBS, PhD
role: Principal Investigator
affiliation: Joint Director, SAS
last name: Sunita Taneja, MBBS, PhD
role: Principal Investigator
affiliation: Research Coordinator, SAS
last name: Gagandeep Kang, MD PhD FRCPath
role: Principal Investigator
affiliation: Professor and Head,The Wellcome Trust Research Laboratory,Christian Medical College
last name: Tor A Strand, MD, PhD
role: Principal Investigator
affiliation: Adjunct Professor, CIH
facility: 
country: India
responsible party type: Sponsor