Completed PHASE1 INTERVENTIONAL 1-arm NCT01375907

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

A Phase 1 Study to Evaluate Safety and Reactogenicity of a Vietnamese Rotavirus Vaccine (Rotavin-M1 at 10e6.3FFU/Dose) Among Healthy Adults in Vietnam

Sponsor: Center for Research and Production of Vaccines and Biologicals

Conditions Diarrhea Fever Irritability Nausea Vomit

Interventions Rotavin

Updated 6 times since 2017 Last updated: Jul 1, 2016 Started: Aug 31, 2009 Primary completion: Oct 31, 2009 Completion: Oct 31, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01375907, this PHASE1 trial focuses on Diarrhea and Fever and remains completed. Sponsored by Center for Research and Production of Vaccines and Biologicals, it has been updated 6 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE1
Sep 2024 — Sep 2025 [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Jun 2018 — Jan 2021 [monthly]

Completed PHASE1

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE1

First recorded

Aug 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Center for Research and Production of Vaccines and Biologicals
National Institute of Hygiene and Epidemiology, Vietnam

Data source: National Institute of Hygiene and Epidemiology, Vietnam

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Thanh Sơn, Vietnam