Ignite Creation Date:
2024-05-05 @ 12:11 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00263666
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2005-12-08
Brief Title:
A Study of Safety Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase II Double-blind Randomized Placebo-controlled Study to Assess the Safety Reactogenicity and Immunogenicity of Three Doses of GlaxoSmithKline GSK Biologicals Oral Live Attenuated Human Rotavirus HRV Vaccine
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this study is to evaluate the reactogenicity safety and immunogenicity of GSK Biologicals human rotavirus HRV vaccine given concomitantly with routine vaccines including OPV in HIV positive infants The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
HIV infected infants as determined prior to study entry screening and asymptomatic or mildly symptomatic WHO stages I and II of disease will be enrolled The study will have two groups Group HRV and Group Placebo Three-dose immunisation will be administered at approximately 6 10 and 14 weeks of age Routine EPI Expanded Program on Immunisation vaccinations will be administered concomitantly with the study vaccines At the time of first dose subjects will be aged 6 to 10 weeks This study will evaluate safety reactogenicity and immunogenicity of the HRV vaccine relative to the placebo
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-001484-39 | EUDRACT_NUMBER | None | None |