Evaluate Safety & Immunogenicity of 2 or 3 Doses of GSK HRV Vaccine in Healthy Infants in South Africa

A Phase II, Randomized, Double-blind, Placebo-controlled Study of Safety, Reactogenicity and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus Vaccine at 10E6.5 CCID50 Viral Concentration in Healthy Infants (Approximately 5-10 Weeks Old) in the Republic of South Africa

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00383903

Enrollment

472

Registered

2006-10-04

Start date

2003-09-30

Completion date

2004-09-30

Last updated

2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Rotavirus

Brief summary

The purpose of this study is to determine the appropriate regimen of GSK HRV vaccine for concomitant administration with EPI vaccines to infants in South Africa.

Interventions

BIOLOGICALHRV vaccine

Two or three oral doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

5 Weeks to 10 Weeks

Healthy volunteers

Yes

Inclusion criteria

* Healthy infants born after a normal gestation period (\>=36 weeks), between 5 and 10 weeks of age at Dose 1 with confirmed negative HIV status of the subject's mother. * Written informed consent was obtained from the parent/guardian of the subject before study entry.

Exclusion criteria

* History of allergic disease/polio disease, * Confirmed or suspected immunosuppressive or immunodeficient condition, * Clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator, * Received treatment prohibited by the protocol. * Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

Design outcomes

Primary

Measure	Time frame
Seroconversion after HRV vaccination	—

Secondary

Measure	Time frame
shedding, serum anti-rota IgA antibody concentrations, anti-polio 1, 2 and 3 seroprotection rates, reactogenicity, safety	—

Countries

South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026