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Proposal 1090

Title of the Proposed Research

Validating the test-negative case-control design for estimating rotavirus vaccine effectiveness using gold-standard randomized controlled trial data from South Africa and Malawi (Rota-037)

Lead Researcher

M. Elizabeth Halloran

Affiliation

Fred Hutchinson Cancer Research Center
University of Washington
Seattle, WA
USA

Funding Source

Gates Foundation to PATH with subcontract to Fred Hutchinson Cancer Research Center and additional NIH/NIAID Grant Funding

Potential Conflicts of Interest

Lead Researcher:
Merck (HPV Vaccine Scientific Advistory Committee) - no conflict
Sanofi Pasteur (Dengue Vaccine) - no conflict

Data Sharing Agreement Date

15 Apr 2015

Lay Summary

Rotavirus is the leading cause of severe diarrhea in children worldwide. Annually there are about 453,000 deaths caused by rotavirus diarrhea in children. Most of these deaths occur in sub-Saharan Africa and south Asia. Recently low-income countries have introduced rotavirus vaccine into national immunization schedules. Researchers have begun to conduct test-negative case-control studies for rotavirus vaccine. This is a study design that may minimize bias and can be conducted easily. The test-negative case-control design has been validated for influenza vaccines by analyzing randomized clinical trial data as if it were collected through an observational case-control study. A similar validation method could be used for rotavirus vaccine. This can be accomplished by analyzing the dataset from the Rotarix-037 vaccine clinical trial. We will compare original estimates of efficacy of Rotarix from the 037 trial to those generated using a test-negative case-control design.

Findings: We will publish the results in a peer-reviewed scientific journal. Results will inform future studies on the effectiveness of rotavirus vaccine.

Study Data Provided

Study 102248: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants
Study 111274: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants

Statistical Analysis Plan

Publication Citation

http://dx.doi.org/10.1016/j.vaccine.2016.10.077