Does the Fecal Microbiome Influence Rotarix Immunogenicity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2013-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Rotavirus Infections Reaction - Vaccine Nos Intestinal Bacteria Flora Disturbance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Case: non-rotavirus seroconverters

Infants not demonstrating seroconversion to rotavirus vaccination, as measured anti-RV Immunoglobulin A \< 20 U/ml

No interventions assigned to this group

Control: rotavirus seroconverters

Infants demonstrating seroconversion to rotavirus vaccination, as measured by anti-rotavirus Immunoglobulin A \> 20 U/ml

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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.
* Positive serum anti-rotavirus Immunoglobulin A (\> 20 U/ml) at 6 weeks of age, indicative of prior rotavirus infection

Minimum Eligible Age

4 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No