Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Malaria

Treatments: Biological: GSK malaria vaccine 257049 Vaccine; Biological: Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380393

106464

Details and patient eligibility

About

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 in order to comply with the FDA Amendment Act, Sep 2007.

Enrollment: 894 patients

Sex: All

Ages: 5 to 17 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 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 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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894 participants in 2 patient groups

GSK257049 Group

Experimental group

Description:

Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of GSK257049 vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.

Treatment:

Biological: GSK malaria vaccine 257049 Vaccine

Rabipur Group

Active Comparator group

Description:

Male or female subjects between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine administered intramuscularly in the left deltoid muscle at Days 0, 30 and 60.

Treatment:

Biological: Sanofi-Pasteur's Human Diploid Cell Rabies Vaccine