Innate Immune Response Clinical Trial
Official title:
Predictors of Poor Immune Response to Rotavirus Vaccine in Infants
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
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