NCT01162590 is a Phase 1 clinical trial of Rotarix ™ in Infections, Rotavirus, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01162590?

NCT01162590 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01162590?

Interventions in NCT01162590: Rotarix ™, Placebo.

What condition does NCT01162590 study?

NCT01162590 studies Infections, Rotavirus.

Is NCT01162590 still recruiting?

NCT01162590 is currently completed. Last updated 19 May 2017.

Last reviewed 2017-05-19 · How we verify

NCT01162590

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

Study to Evaluate the Reactogenicity and Safety of Rotarix™ in Chinese Adults

Completed Phase 1 Last updated 19 May 2017

What this trial tests

Phase 1 trial testing Rotarix ™ in Infections, Rotavirus in 52 participants. Completed in 31 March 2010.

Timeline

1 March 2010

Primary endpoint
31 March 2010

31 March 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	52
Start date	1 March 2010
Primary completion	31 March 2010
Estimated completion	31 March 2010
Sites	1 location across China

Drugs / interventions tested

Rotarix ™
Placebo

Conditions studied

Infections, Rotavirus — all drugs for Infections, Rotavirus →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 45, any sex, with Infections, Rotavirus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the safety of Rotarix ™ when administered in healthy adults aged 18 to 45 years in China.

Publications & conference data

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

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
Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China: randomized, double-blind, placebo-controlled Phase I studies.
Li RC, Li YP, Mo ZJ, Luo D, et al · · 2013 · cited 8× · PMID 23807360 · DOI 10.4161/hv.25076

Verify or expand the search:

Other trials of Rotarix ™

Trials testing the same drug.

NCT01086436 — Study to Evaluate the Safety of Rotarix™ in Chinese Children · Phase 1 · completed
NCT00969228 — Study to Evaluate Immunogenicity, Reactogenicity and Safety of Rotarix™ Vaccine in Korean Infants · Phase 4 · completed

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

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 NCT01162590 (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 GlaxoSmithKline
Last refreshed: 19 May 2017

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/NCT01162590.

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