NCT01375907 is a Phase 1 clinical trial of Rotavin in Diarrhea, sponsored by National Institute of Hygiene and Epidemiology, Vietnam.

Who is sponsoring NCT01375907?

NCT01375907 is sponsored by National Institute of Hygiene and Epidemiology, Vietnam.

What drugs are being tested in NCT01375907?

Interventions in NCT01375907: Rotavin.

What condition does NCT01375907 study?

NCT01375907 studies Diarrhea, Vomit, Fever, Nausea, Irritability.

Is NCT01375907 still recruiting?

NCT01375907 is currently completed. Last updated 1 July 2016.

Last reviewed 2016-07-01 · How we verify

NCT01375907

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

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

Completed Phase 1 Last updated 1 July 2016

What this trial tests

Phase 1 trial testing Rotavin in Diarrhea in 29 participants. Completed in 1 October 2009.

Timeline

1 August 2009

Primary endpoint
1 October 2009

1 October 2009

Quick facts

Lead sponsor	National Institute of Hygiene and Epidemiology, Vietnam
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Enrollment	29
Start date	1 August 2009
Primary completion	1 October 2009
Estimated completion	1 October 2009
Sites	1 location across Vietnam

Drugs / interventions tested

Rotavin — full drug profile →

Conditions studied

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

Sponsor

National Institute of Hygiene and Epidemiology, Vietnam

Who can join

Adults 18 to 40, any sex, with Diarrhea or Vomit. Healthy volunteers can join.

What's being measured

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

Safety of Rotavin-M1 vaccine in healthy adult volunteers
Time frame: 3 months
To evaluate the safety of 2 doses Rotavin-M1 vaccine (10e6.3FFU/dose, 1-month interval between doses) in healthy adult volunteers.

Sponsor's own description

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.

Publications & conference data

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

A dose-escalation safety and immunogenicity study of a new live attenuated human rotavirus vaccine (Rotavin-M1) in Vietnamese children.
Dang DA, Nguyen VT, Vu DT, Vu DT, et al · · 2012 · cited 53× · PMID 22520120 · DOI 10.1016/j.vaccine.2011.07.118
Vaccines for preventing rotavirus diarrhoea: vaccines in use.
Soares-Weiser K, Bergman H, Henschke N, Pitan F, et al · · 2019 · cited 40× · PMID 31684685 · DOI 10.1002/14651858.cd008521.pub5
Vaccines for preventing rotavirus diarrhoea: vaccines in use.
Soares-Weiser K, Bergman H, Henschke N, Pitan F, et al · · 2019 · cited 40× · PMID 30912133 · DOI 10.1002/14651858.cd008521.pub4
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.

NCT07285785 — Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea · Phase 4 · recruiting
NCT07385196 — Defining Ileorectal Syndrome: a Prospective Observational Study · recruiting
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 NCT01375907 (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: 1 July 2016

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/NCT01375907.

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