NCT01377571 is a Phase 2 clinical trial of Rotarix in Diarrhea, sponsored by National Institute of Hygiene and Epidemiology, Vietnam.

Who is sponsoring NCT01377571?

NCT01377571 is sponsored by National Institute of Hygiene and Epidemiology, Vietnam.

What drugs are being tested in NCT01377571?

Interventions in NCT01377571: Rotarix.

What condition does NCT01377571 study?

NCT01377571 studies Diarrhea, Fever, Nausea, Vomit, Irritability.

Is NCT01377571 still recruiting?

NCT01377571 is currently completed. Last updated 30 June 2016.

Last reviewed 2016-06-30 · How we verify

NCT01377571

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

A Phase II, Randomized, Double-blind, Vaccine-controlled Dose-escalating Study to Evaluate the Immunogenicity, Reactogenicity and Safety of Oral Live Attenuated Human Rotavirus (HRV) Vaccine (Rotavin-M1) in Healthy Infants in Vietnam

Completed Phase 2 Last updated 30 June 2016

What this trial tests

Phase 2 trial testing Rotarix in Diarrhea in 200 participants. Completed in 1 April 2010.

Timeline

1 October 2009

Primary endpoint
1 March 2010

1 April 2010

Quick facts

Lead sponsor	National Institute of Hygiene and Epidemiology, Vietnam
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Enrollment	200
Start date	1 October 2009
Primary completion	1 March 2010
Estimated completion	1 April 2010
Sites	1 location across Vietnam

Drugs / interventions tested

Rotarix — 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.

To assess immunogenicity of a new rotavirus vaccine Rotavin-M1 in terms of anti-rotavirus IgA antibody seroconversion 1 month after complete the vaccination schedule
Time frame: up to 7 months
To assess immunogenicity of Rotavin-M1 of 2 titers (10e6.0 and 10e6.3FFU/dose) and 2 schedules (3 doses and 1-month interval between vs 2 doses and 2-month interval between doses), compared with 2 doses GSK's lyophilized Rotarix (10e6.5 CID50/dose).

Sponsor's own description

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.

Publications & conference data

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

Vaccines for preventing rotavirus diarrhoea: vaccines in use.
Bergman H, Henschke N, Hungerford D, Pitan F, et al · · 2021 · cited 57× · PMID 34788488 · DOI 10.1002/14651858.cd008521.pub6
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
Noninvasive vaccination against infectious diseases.
Zheng Z, Diaz-Arévalo D, Guan H, Zeng M. · · 2018 · cited 46× · PMID 29624470 · DOI 10.1080/21645515.2018.1461296
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 trials of Rotarix

Trials testing the same drug.

NCT06824181 — Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjug · Phase 3 · active not recruiting
NCT06824194 — Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age · Phase 3 · active not recruiting
NCT04658914 — Human Challenge With Live-attenuated Rotavirus to Assess Next-generation Rotavirus Vaccines in Africa · Phase 2 · completed
NCT04344054 — Mixed Schedule Study of Live Oral Rotavirus Vaccines and Trivalent P2-VP8 Subunit Rotavirus Vaccine · Phase 2 · completed
NCT04010448 — A Trial to Assess the Safety, Immunogenicity and Efficacy of a Trivalent Rotavirus P2-VP8 Subunit Vaccine in Prevention · Phase 3 · unknown

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 NCT01377571 (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 June 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/NCT01377571.

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