Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Malaria

Treatments: Biological: Rabipur; Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Study type: Interventional

Funder types: Industry

Identifiers

NCT00360230

106367

Details and patient eligibility

About

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 Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Full 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-schedule will receive a Rabies vaccine as a control. One group on the same schedule will receive the RTS,S/AS02D experimental vaccine as an active comparator.

Enrollment: 540 patients

Sex: All

Ages: 5 to 17 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 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 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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540 participants in 7 patient groups

SB257049 F2 0-1 M Group

Experimental group

Description:

Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Treatment:

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

SB257049 F1 0-1 M Group

Experimental group

Description:

Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Treatment:

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

SB257049 F2 0-1-2 M Group

Experimental group

Description:

Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Treatment:

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

SB257049 F1 0-1-2 M Group

Experimental group

Description:

Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Treatment:

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

SB257049 F2 0-1-7 M Group

Experimental group

Description:

Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Treatment:

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

SB257049 F1 0-1-7 M Group

Active Comparator group

Description:

Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Treatment:

Biological: GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049

Rabipur 0-1-2 M Group

Active Comparator group

Description:

Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.

Treatment:

Biological: Rabipur