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Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children — Rotavin-M1  

Diarrhea Clinical Trial

Official title:
A Phase 2b Study of Rotavin-M1 Vaccine in Vietnamese Children

Clinical Trial Summary

This is a multiple-site phase 2b, randomized, placebo control study to evaluate the safety and immunogenicity of Rotavin-M1, produced by the Center for Research and Production of Vaccines and Biologicals, Vietnam.

Clinical Trial Description

The investigators evaluate the vaccine schedule consisting of 2 doses of Rotavin-M1, 10e6.3ffu/dose at 2 month interval in children in two study sites, Thanh Son- Phu Tho and Thai Binh city-Thai Binh provinces.

This vaccine dose and schedule was chosen based on results from the previous dose-escalating study (NCT01377571). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01502969
Study type Interventional
Source National Institute of Hygiene and Epidemiology, Vietnam
Contact
Status Completed
Phase Phase 2/Phase 3
Start date May 2010
Completion date October 2011
View Details
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