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A Dose-escalating Study to Evaluate the Immunogenicity and Safety of Rotavin-M1 Vaccine in Healthy Infants

NCT01377571 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-07-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immunogenicity of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in infants in Vietnam. In addition, we evaluate different dosages and schedules to determine the best regimen to test in a clinical trial.

Conditions

Interventions

BIOLOGICAL

Rotarix

2 doses of Rotarix vaccine, 106.5CID/dose, 1-month interval between doses

Sponsors & Collaborators

  • Center for Research and Production of Vaccines and Biologicals, Vietnam

    collaborator OTHER_GOV

  • National Institute of Hygiene and Epidemiology, Vietnam

    lead OTHER

Principal Investigators

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

  • Thiem D Vu, MD., PhD. · The National Institute of Hygiene and Epidemiology

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-03-31
Completion
2010-04-30

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 NCT01377571 on ClinicalTrials.gov