NCT01700127

Brief 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®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2012

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

June 26, 2013

Status Verified

June 1, 2013

Enrollment Period

7 months

First QC Date

September 28, 2012

Last Update Submit

June 25, 2013

Conditions

Innate Immune Response

Keywords

immune responseinfantsrotavirus vaccine

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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.

    14-18 weeks of age

Other Outcomes (1)

  • 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

    upto 14-18 weeks of age

Study Arms (2)

Breastfeeding

OTHER

Breastfeeding Encouraged

Other: Breastfeeding

Breastfeeding Withheld

ACTIVE COMPARATOR

Breastfeeding Withheld

Other: Breastfeeding

Interventions

BreastfeedingOTHER

breastfeeding encouraged versus withheld

BreastfeedingBreastfeeding Withheld

Eligibility Criteria

Age6 Weeks - 7 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • At least one parent(s) or legally acceptable representative's consent for participation and are able to understand study procedures
  • Subjects aged 6 to 7 weeks at recruitment
  • No plans to move in the next 4 months
  • Weight for age not ≤ -3 SD of WHO child growth standards

You may not qualify if:

  • Infant not breastfed
  • Administration of rotavirus vaccine in the past
  • Known immunodeficiency disease, including HIV infection in the subject or the mother
  • Known chronic enteric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Health Research and Development Society for Applied Studies

New Delhi, National Capital Territory of Delhi, 110016, India

Location

Related Publications (2)

  • Rongsen-Chandola T, Strand TA, Goyal N, Flem E, Rathore SS, Arya A, Winje BA, Lazarus R, Shanmugasundaram E, Babji S, Sommerfelt H, Vainio K, Kang G, Bhandari N. Effect of withholding breastfeeding on the immune response to a live oral rotavirus vaccine in North Indian infants. Vaccine. 2014 Aug 11;32 Suppl 1:A134-9. doi: 10.1016/j.vaccine.2014.04.078.

    PMID: 25091668DERIVED

  • Rongsen-Chandola T, Winje BA, Goyal N, Rathore SS, Mahesh M, Ranjan R, Arya A, Rafiqi FA, Bhandari N, Strand TA. Compliance of mothers following recommendations to breastfeed or withhold breast milk during rotavirus vaccination in North India: a randomized clinical trial. Trials. 2014 Jun 28;15:256. doi: 10.1186/1745-6215-15-256.

    PMID: 24976452DERIVED

MeSH Terms

Interventions

Lactation

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Officials

  • Temsunaro R Chandola, MBBS MSc Epi

    Research Scientist, SAS

    PRINCIPAL INVESTIGATOR

  • Nita Bhandari, MBBS, PhD

    Joint Director, SAS

    PRINCIPAL INVESTIGATOR

  • Sunita Taneja, MBBS, PhD

    Research Coordinator, SAS

    PRINCIPAL INVESTIGATOR

  • Gagandeep Kang, MD PhD FRCPath

    Professor and Head,The Wellcome Trust Research Laboratory,Christian Medical College

    PRINCIPAL INVESTIGATOR

  • Tor A Strand, MD, PhD

    Adjunct Professor, CIH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2012

First Posted

October 4, 2012

Study Start

October 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 26, 2013

Record last verified: 2013-06

Locations

IN(1)