To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV

Reactogenicity & Immunogenicity Study of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Co-administered With Either OPV or IPV in Healthy Infants (Approximately 5-10 Weeks Old) in South Africa

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00346892

Enrollment

450

Registered

2006-06-30

Start date

2001-11-30

Completion date

Unknown

Last updated

2016-09-09

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

Conditions

Rotavirus Infections

Keywords

Prophylaxis rotavirus

Brief summary

The primary objective of this study was to demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of combined vaccines. The primary objective was reached if one month after the third dose of polio vaccine, upper limit of the 95% CI for the difference in Seroprotection rate between the group B and C pooled and (minus) the group A was below 10% for each polio serotype.

Detailed description

The study had three groups: Group A: HRV + OPV + DTPa/Hib; Group B: HRV + placebo OPV + DTPa-IPV/Hib; Group C: HRV Placebo + OPV + DTPa/Hib. Two cohorts: Subjects enrolled before the 2002 RV season were to receive two doses of HRV or placebo at approximately 6 and 10 weeks of age (first cohort) and subjects enrolled after the 2002 RV season received vaccinations at approximately 10 and 14 weeks of age (second cohort). Routine EPI vaccinations were to be administered concomitantly with the study vaccines.

Interventions

BIOLOGICALRotavirus (vaccine)

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 between 5 and 10 weeks of age at first study vaccination with (after the 2002 RV season) confirmed negative HIV status of the subject's mother during pregnancy or thereafter.

Exclusion criteria

History of allergic disease, any confirmed or suspected immunosuppressive or immunodeficient condition, clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator or had not received treatment prohibited by the protocol.

Design outcomes

Primary

Measure	Time frame
Seroprotection for each polio serotype 1 month after the 3rd dose.	—

Secondary

Measure	Time frame
Proportion of subjects with vaccine take 1 month after each dose of study vaccine, viral shedding in a subset of subjects, presence of RV in diarrheal stools, anti-rota IgA antibody seroconversion rate and serum anti-rota IgA antibody concent	—

Countries

South Africa

Outcome results

None listed

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