NCT01502969 (Rotavin-M1) is a Phase 2/Phase 3 clinical trial of Rotavin-M1 in Diarrhea, sponsored by National Institute of Hygiene and Epidemiology, Vietnam.

Who is sponsoring NCT01502969?

NCT01502969 is sponsored by National Institute of Hygiene and Epidemiology, Vietnam.

What drugs are being tested in NCT01502969?

Interventions in NCT01502969: Rotavin-M1, cell culture medium in absence of virus.

What condition does NCT01502969 study?

NCT01502969 studies Diarrhea, Fever, Nausea, Vomit, Irritability.

Is NCT01502969 still recruiting?

NCT01502969 is currently completed. Last updated 30 December 2011.

Last reviewed 2011-12-30 · How we verify

NCT01502969: Rotavin-M1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2/Phase 3 Last updated 30 December 2011

What this trial tests

Phase 2/Phase 3 trial testing Rotavin-M1 in Diarrhea in 799 participants. Completed in 1 October 2011.

Timeline

1 May 2010

Primary endpoint
1 September 2011

1 October 2011

Quick facts

Lead sponsor	National Institute of Hygiene and Epidemiology, Vietnam
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	799
Start date	1 May 2010
Primary completion	1 September 2011
Estimated completion	1 October 2011
Sites	2 locations across Vietnam

Drugs / interventions tested

Rotavin-M1 — full drug profile →
cell culture medium in absence of virus — full drug profile →

Conditions studied

Diarrhea — all drugs for Diarrhea →
Fever — all drugs for Fever →
Nausea — all drugs for Nausea →
Vomit — all drugs for Vomit →

Sponsor

National Institute of Hygiene and Epidemiology, Vietnam

Who can join

Adults 6 Weeks to 12 Weeks, any sex, with Diarrhea or Fever. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Anti-rotavirus IgA antibody responses 1 month after vaccination
Time frame: 12 months
To assess IgA antibody responses 1 month after completing 2 doses of Rotavin-M1, 10e6.3ffu/dose

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The rotavirus vaccine development pipeline.
Kirkwood CD, Ma LF, Carey ME, Steele AD. · · 2019 · cited 90× · PMID 28396207 · DOI 10.1016/j.vaccine.2017.03.076
Product review of the rotavirus vaccines ROTASIIL, ROTAVAC, and Rotavin-M1.
Skansberg A, Sauer M, Tan M, Santosham M, et al · · 2021 · cited 30× · PMID 33121329 · DOI 10.1080/21645515.2020.1804245

Verify or expand the search:

Other recruiting trials for Diarrhea

Currently open trials in the same condition.

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NCT07205926 — First in Human Dose Escalation Study Evaluating the Safety and Immunogenicity of IVT's Shigella-04 Vaccine in Healthy Yo · Phase 1 · recruiting
NCT07484412 — Efficacy and Safety of Encapsulated Bifidobacterium Longum BBH016 in Subjects With Lower Gastrointestinal Symptoms · NA · active not recruiting
NCT06801067 — A Study of SER-155 to Treat Diarrhea in People on Immunotherapy · Phase 1 · recruiting

Other National Institute of Hygiene and Epidemiology, Vietnam trials

Trials by the same sponsor.

NCT06681636 — Effector and Memory Immune Responses to HPV Vaccination in Vietnamese Women Post Virus Exposure · Phase 2 · not yet recruiting
NCT03282370 — Evaluate Safety and Immunogenicity of a Vero Cell-Derived JE Vaccine in 9-24 Months of Age Children in Vietnam · Phase 3 · completed
NCT03204227 — Safety of Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) in Children From 9-24 Months of Age · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01502969 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Hygiene and Epidemiology, Vietnam
Last refreshed: 30 December 2011

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01502969.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing