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Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children

NCT01502969 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 799

Last updated 2012-01-02

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Rotavin-M1

liquid, 10e6ffu/dose, 2 doses, 2 month interval

BIOLOGICAL

cell culture medium in absence of virus

Placebo

Sponsors & Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam

    lead OTHER

Principal Investigators

  • Dang D Anh, PhD · The National Institute of Hygiene and Epidemiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Weeks
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-09-30
Completion
2011-10-31

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01502969 on ClinicalTrials.gov