Status:
COMPLETED
Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
Brief Summary
This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Proto...
Detailed Description
This study will be conducted in a partially blind fashion: it will be observer-blind as to which vaccine was administered, and open as to the vaccination schedule. One group of children on the 0, 1, 2...
Eligibility Criteria
Inclusion
- A male or female child between 5 months and 17 months of age at the time of first vaccination.
- Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in infancy.
Exclusion
- Acute disease at the time of enrolment.
- Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
- Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
- Planned administration/administration of a vaccine (not in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled Yellow fever or Measles vaccine.
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine, or planned use during the study period.
- Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Simultaneous participation in any other clinical trial;
- Previous participation in any other malaria vaccine trial;
- Any 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 vaccine.
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Key Trial Info
Start Date :
August 30 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2008
Estimated Enrollment :
540 Patients enrolled
Trial Details
Trial ID
NCT00360230
Start Date
August 30 2006
End Date
May 30 2008
Last Update
February 19 2018
Active Locations (2)
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1
GSK Investigational Site
Kintampo, Ghana
2
GSK Investigational Site
Kumasi, Ghana