Predictors of Poor Immune Response to Rotavirus Vaccine in Infants (PPIR)

NCT01700127 NA COMPLETED

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®.

Details

Lead sponsor	Society for Applied Studies
Phase	NA
Status	COMPLETED
Enrolment	400
Start date	2012-10
Completion	2013-05

Conditions

• Innate Immune Response

Interventions

• Breastfeeding

Primary outcomes

• 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®. — 14-18 weeks of age

Countries

India