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Safety Study of a Rotavirus Vaccine (Rotavin-M1) Among Healthy Adults

NCT01375907 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2016-07-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety of Rotavin-M1 produced by the Center for Research and Production of Vaccines and Biologicals (POLYVAC) in adult volunteers in Vietnam.

Conditions

Interventions

DRUG

Rotavin

Rotavin-M1, 10e6.3FFU/dose, 2 doses, 1-month between doses

Sponsors & Collaborators

  • Center for Research and Production of Vaccines and Biologicals

    collaborator UNKNOWN

  • National Institute of Hygiene and Epidemiology, Vietnam

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-10-31
Completion
2009-10-31

Countries

  • Vietnam

Study Locations

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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 NCT01375907 on ClinicalTrials.gov