Status:
COMPLETED
Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria
Eligibility:
All Genders
18-48 years
Phase:
PHASE2
Brief Summary
GSK Biologicals is developing a number of candidate malaria vaccines for the routine immunization of infants and children living in malaria-endemic areas. The candidate vaccines are designed to offer ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- A male or female child between 18 months and 4 years of age (up to but not including 5th birthday) 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 (e.g. return for follow-up visits)
- Exclusion criteria:
- 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 range.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid.
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of 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.
- Previous participation in any other malaria vaccine trial.
- Simultaneous participation in any other clinical trial.
- Same sex twin.
- 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.
Exclusion
Key Trial Info
Start Date :
April 7 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2007
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00307021
Start Date
April 7 2006
End Date
August 22 2007
Last Update
April 25 2017
Active Locations (1)
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1
GSK Investigational Site
Lambaréné, Gabon