Trials / Completed
CompletedNCT02220439
Does the Fecal Microbiome Influence Rotarix Immunogenicity
Nested Case-control Analysis of the Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 76 (actual)
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
- Sex
- All
- Age
- 4 Weeks
- Healthy volunteers
- Not accepted
Summary
This is a proposal for a nested case-control study within an ongoing rotavirus vaccine immunogenicity clinical trial Karachi, Pakistan. The primary study aim is to compare the fecal microbiota composition and diversity of infants who do (control) and do not (case) demonstrate immune seroconversion to rotavirus vaccination. The infants will be matched for vaccination dose, age and breast-feeding practices.
Conditions
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2013-11-01
- Completion
- 2013-11-01
- First posted
- 2014-08-20
- Last updated
- 2014-08-20
Source: ClinicalTrials.gov record NCT02220439. Inclusion in this directory is not an endorsement.