Status:
COMPLETED
Safety and Immunogenicity of GSK Biologicals' Investigational Malaria Vaccine in HIV Infected Infants and Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the safety and immunogenicity of the candidate malaria vaccine in HIV-infected infants and children
Detailed Description
This protocol posting has been updated due to protocol Amendment 2.
Eligibility Criteria
Inclusion
- All subjects must satisfy ALL the following criteria at study entry:
- A male or female infant or child between and including 6 weeks to 17 months of age, at the time of first vaccination.
- Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the infant or child. Where parents/LARs are illiterate, the consent form will be countersigned by a witness.
- Subjects who the investigator believes that their parents/LARs can and will comply with the requirements of the protocol should be enrolled in the study.
- Subjects who are known to be HIV-infected (documented positive DNA PCR), whether taking HIV antiretroviral treatment (ART) or not.
- Subjects who are born following a normal gestation period.
Exclusion
- The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:
- Acute disease at the time of enrolment. However, the presence of an illness listed as Grade I or Grade II (WHO pediatric AIDS clinical staging) will not of itself constitute an exclusion criterion. Enrolment should be deferred if axillary temperature is \>=37.5°C.
- Grade III or Grade IV abnormality on screening laboratory blood sample.
- Grade III or IV AIDS at the time of enrolment (WHO pediatric AIDS clinical staging).
- Major congenital defects.
- Planned administration/administration of a vaccine not foreseen by the study protocol prior to or within 7 days of study vaccine.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine 30 days preceding Dose°1 of study vaccine, or planned use during the study period.
- Previous participation in any other malaria vaccine trial.
- Simultaneous participation in another clinical trial including administration of experimental treatment.
- Same sex twins.
- History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine.
- Child in care.
Key Trial Info
Start Date :
July 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 24 2013
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01148459
Start Date
July 30 2010
End Date
May 24 2013
Last Update
January 16 2019
Active Locations (2)
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1
GSK Investigational Site
Kisian, Kenya
2
GSK Investigational Site
Kisumu, Kenya