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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Brief Summary

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"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."

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Detailed Description

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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.

Conditions

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Rotavirus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Rotavirus (vaccine)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

5 Weeks

Maximum Eligible Age

10 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Pretoria, , South Africa

Site Status

Countries

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South Africa

Study Documents

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