Status:
COMPLETED
A Study of Safety, Reactogenicity and Immunogenicity of HRV Vaccine in HIV Infected Infants in South Africa
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Rotavirus
Eligibility:
All Genders
6-10 years
Phase:
PHASE2
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 posi...
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 ...
Eligibility Criteria
Inclusion
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including 6 and 10 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parents or guardians of the subject
- Documented HIV status of the subject as confirmed by PCR.
- HIV asymptomatic and HIV mildly symptomatic; Stages I and II disease according to WHO's most recent classification for HIV stages in infants and children.
- Born after a gestation period of 36 to 42 weeks.
Exclusion
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Previous routine vaccination except OPV, BCG and HBV vaccination at birth
- Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract or other serious medical condition as determined by the investigator.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine.
- Acute disease at time of enrolment.
- Gastroenteritis within 7 days preceding the study vaccine administration.
- Previous confirmed occurrence of RV gastroenteritis.
- Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
- HIV moderately and severely symptomatic: stages III and IV according to WHO's recent classification.
- Administration of immunoglobulins and/or blood products since birth or planned administration during the study period.
Key Trial Info
Start Date :
March 16 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 13 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00263666
Start Date
March 16 2005
End Date
February 13 2008
Last Update
November 23 2020
Active Locations (6)
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1
GSK Investigational Site
Attridgerville, Gauteng, South Africa, 0008
2
GSK Investigational Site
Coronationville, Gauteng, South Africa, 2112
3
GSK Investigational Site
Garankuwa, North West, South Africa, 0204
4
GSK Investigational Site
Brits, South Africa, 0250