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Does the Fecal Microbiome Influence Rotarix Immunogenicity

NCT02220439 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 76

Last updated 2014-08-20

No results posted yet for this study

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

  • Rotavirus Infections
  • Reaction - Vaccine Nos
  • Intestinal Bacteria Flora Disturbance

Sponsors & Collaborators

  • Aga Khan University

    collaborator OTHER

  • Centers for Disease Control and Prevention

    collaborator FED

  • University of Padova

    collaborator OTHER

  • Wageningen University and Research

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Vanessa C Harris, MD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility

Min Age
4 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02220439 on ClinicalTrials.gov