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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02220439
Other study ID # AIGHD-CSP2013-001a
Secondary ID
Status Completed
Phase N/A
First received June 10, 2014
Last updated August 19, 2014
Start date September 2013
Est. completion date November 2013

Study information

Verified date August 2014
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact n/a
Is FDA regulated No
Health authority Pakistan: Research Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date November 2013
Est. primary completion date November 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

- 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Aga Khan University, Centers for Disease Control and Prevention, University of Padua, Wageningen University and Research Centre

Outcome

Type Measure Description Time frame Safety issue
Primary microbiome diversity (Shannon's index) and composition (relative abundance) Microbiota composition will be measured by calculating and comparing a % of the phylogenetic groups present in both groups
Diversity will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups
The relative abundance of microbial groups will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups
at 6 weeks of age, pre-rotavirus vaccination No
Secondary microbiome diversity (Shannon's index) and composition (relative abundance) Microbiota composition post vaccination will be measured by calculating and comparing a % of the phylogenetic groups present in both groups
Diversity post vaccination will be measured by calculating a comparing a Shannon's reciprocal index of diversity, 1/D in both groups
The relative abundance of microbial groups post vaccination will be measured by calculating and comparing the ribosomal ribonucleic acid gene copy per gram of feces over time in both groups
at 1 to 3 years of age post-rotavirus vaccination No
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