NCT01502969

Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 799 (actual)
• Sponsor: National Institute of Hygiene and Epidemiology, Vietnam · Academic / Other
• Sex: All
• Age: 6 Weeks – 12 Weeks
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Diarrhea
• Fever
• Nausea
• Vomit
• Irritability

Interventions

Type	Name	Description
BIOLOGICAL	Rotavin-M1	liquid, 10e6ffu/dose, 2 doses, 2 month interval
BIOLOGICAL	cell culture medium in absence of virus	Placebo

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2012-01-02
• Last updated: 2012-01-02

Locations

2 sites across 1 country: Vietnam