To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV
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|ClinicalTrials.gov Identifier: NCT00346892|
Recruitment Status : Completed
First Posted : June 30, 2006
Last Update Posted : September 9, 2016
"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."
|Condition or disease||Intervention/treatment||Phase|
|Rotavirus Infections||Biological: Rotavirus (vaccine)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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|
|Study Start Date :||November 2001|
|Actual Primary Completion Date :||March 2003|
- Seroprotection for each polio serotype 1 month after the 3rd dose.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00346892
|Pretoria, South Africa|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|