Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children

Study Overview
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Brief Summary
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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 protection against malaria disease due to the parasite Plasmodium falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection against infection with hepatitis B virus (HBV). This study will evaluate two candidate vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Official Title
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Bridging Safety & Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine RTS,S/AS01E (0.5 mL Dose) to RTS,S/AS02D (0.5 mL Dose) Administered IM According to a 0, 1, 2-Month Schedule in Gabonese Children Aged 18 Months to 4 Years

Conditions
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Malaria

Intervention / Treatment
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* Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br> | Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049<br>* 3-dose intramuscular injection, 2 different formulations<br>|
| Experimental: Group B<br> | Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049<br>* 3-dose intramuscular injection, 2 different formulations<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of SAEs. |  | From the time of first vaccination until one month post Dose 3 | 
| Antibody titers to the P. falciparum circumsporozoite repeat domain (anti-CS). |  | One month post Dose 3. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of solicited general and local reactions. |  | Over a 7-day follow-up period after each vaccination. | 
| Occurrence of unsolicited symptoms. |  | After each vaccination over a 30-day follow-up | 
| Anti-CS antibody titers. |  | Prior to vaccination, one month post Dose 2 | 
| Anti-Hepatitis B surface agent (anti-HBs) antibody titers. |  | Prior to vaccination, one month post Dose 2 and one month post Dose 3. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Malaria, Parasitic Diseases, Malaria, Falciparum, Coccidiosis