Status:
COMPLETED
Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Malaria
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
Brief Summary
This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety. The Protocol Posting has been updated ...
Eligibility Criteria
Inclusion
- A male or female child of 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.
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 foreseen by the study within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled diphtheria, pertussis or measles vaccine.
- 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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 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.
Key Trial Info
Start Date :
January 3 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2008
Estimated Enrollment :
894 Patients enrolled
Trial Details
Trial ID
NCT00380393
Start Date
January 3 2007
End Date
November 11 2008
Last Update
July 3 2018
Active Locations (2)
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1
GSK Investigational Site
Kilifi, Kenya, 80108
2
GSK Investigational Site
Amani, Tanga, Tanzania