Status:
COMPLETED
Does the Fecal Microbiome Influence Rotarix Immunogenicity
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Aga Khan University
Centers for Disease Control and Prevention
Conditions:
Rotavirus Infections
Reaction - Vaccine Nos
Eligibility:
All Genders
4+ years
Brief 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 composi...
Eligibility Criteria
Inclusion
- 6 weeks 0 days to 7 weeks 6 days age at the time of enrollment.
- Healthy infant free of chronic or serious medical condition as determined by history and physical exam at time of enrollment into in the study.
- Written informed consent obtained from the parents or guardians.
- Availability of baseline fecal sample collected before Rotarix vaccination
- Written informed consent obtained from the parents or guardians for nested study
Exclusion
- Hypersensitivity to any of the vaccine components
- Use of any investigational drug or vaccine other than the study vaccine within 30 days of first dose of study vaccine or during the study.
- Use of any immunosuppressive drugs.
- Previous intussusceptions or abdominal surgery.
- Enrollment in any other trial (besides NCT01199874).
- Birth weight less than 1500 grams; or if birth weight is unknown, weight less than 2000 grams on or before 28 days.
- Immunoglobulin and/or blood products use since birth or during the study period. Nested study additional exclusion criteria:
- Positive serum anti-rotavirus Immunoglobulin A (\> 20 U/ml) at 6 weeks of age, indicative of prior rotavirus infection
Key Trial Info
Start Date :
September 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT02220439
Start Date
September 1 2013
End Date
November 1 2013
Last Update
August 20 2014
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