The Influence of the Microbiome on Rotavirus Vaccine Immunogenic Response in Infants in Karachi, Pakistan

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

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-07-31

Brief Summary

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This is a nested case-control study within an ongoing rotavirus vaccine immunogenicity trial in 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

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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rotavirus (Rotarix TM) vaccination

Infants who received rotavirus vaccination (Rotarix TM) at 6 and 10 weeks, 10 and 14 weeks or 6,10, and 14 weeks. This is a nested study and infants received the vaccination in the overarching study: The Immunogenicity of ROtavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding around the Time of Vaccination on the Immunogenicity of Rotarix Vaccine (clinicaltrials.gov: NCT01199874)

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Infants already consented and enrolled in the overarching study: Immunogenicity of Rotavirus Vaccine Under Different Age Schedules and the Impact of Withholding Breast Feeding around the Time of Vaccination on the Immunogenicity or Rotarix Vaccine trial (NCT01199874)

* 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
* written informed consent obtained from parents or legal guardians for this nested study
* availability of a baseline, pre-vaccination fecal sample

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 trials
* birth weight less than 1500 grams; or if birthweight is unknown, weight less than 2000 grams on or before 28 days
* positive serum anti-rotavirus IgA (\> or= 20U/mL) at 6 weeks of age, indicative of rotavirus infection prior to vaccination

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes