Predictors of Poor Immune Response to Rotavirus Vaccine in Infants

Summary

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®.

Conditions

• Innate Immune Response

Interventions

OTHER

Breastfeeding

breastfeeding encouraged versus withheld

Sponsors & Collaborators

• Christian Medical College, Vellore, India

  collaborator OTHER

• Norwegian Institute of Public Health

  collaborator OTHER_GOV

• Society for Applied Studies

  lead OTHER

Principal Investigators

• Temsunaro R Chandola, MBBS MSc Epi · Research Scientist, SAS

• Nita Bhandari, MBBS, PhD · Joint Director, SAS

• Sunita Taneja, MBBS, PhD · Research Coordinator, SAS

• Gagandeep Kang, MD PhD FRCPath · Professor and Head,The Wellcome Trust Research Laboratory,Christian Medical College

• Tor A Strand, MD, PhD · Adjunct Professor, CIH

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Weeks

Max Age

7 Weeks

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-10-31

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

• India

Study Locations