Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever (YF) Vaccines Followed by a Booster of the Malaria Vaccine.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Malaria; Malaria Vaccines

Treatments: Biological: Stamaril; Biological: Candidate Plasmodium falciparum malaria vaccine; Dietary Supplement: Vitamin A; Biological: MR-Vac

Study type: Interventional

Funder types: Industry

Identifiers

NCT02699099

200596

Details and patient eligibility

About

The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and yellow fever vaccines to children aged 6 months at the first vaccination.

Enrollment: 699 patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects' parent(s)/Legally Acceptable Representative(s) (LAR[s]) who, in the opinion of the investigator, could and complied with the requirements of the protocol.
• A male or female 6 months of age (from the day the child becomes 6 months of age until the day before the child achieved 7 months of age) at the time of the first vaccination.
• Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) were illiterate, the consent form was countersigned by an independent witness.
• Healthy subjects as established by medical history and clinical examination before entering into the study.
• Previously received three documented doses of diphtheria, tetanus, and whole-cell pertussis, hepatitis B vaccine (DTPwHepB), and a 3-dose course of oral polio vaccine and, if locally recommended, pneumococcal and rotavirus vaccines.

Exclusion criteria

• Child in care
• Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this meant prednisone≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids were allowed.
• Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before the first dose of SB257049 measles, rubella and YF vaccines and ending 42 days after the last dose of vaccines given at 9 months of age (Visit 4), with the exception of oral polio vaccine which could be given for unforeseen public health threat.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
• Previous vaccination against measles, YF or rubella.
• Previous administration of Vitamin A.
• Moderate or severe malnutrition at screening defined as weight for age Z-score < -2.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Family history of congenital or hereditary immunodeficiency.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). See also Section 1.3.
• Major congenital defects or serious chronic illness.
• History of any neurological disorders or seizures.
• Acute disease and/or fever at the time of enrolment. Fever was defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording temperature in this study was axillary.

Subjects with a minor illness without fever might have been enrolled at the discretion of the investigator.

• Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Same sex twin.
• Maternal death.
• Previous participation in any other malaria study.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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699 participants in 3 patient groups

Coad group

Experimental group

Description:

Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).

Treatment:

Biological: MR-Vac

Biological: Candidate Plasmodium falciparum malaria vaccine

Dietary Supplement: Vitamin A

Biological: Stamaril

RTS,S group

Experimental group

Description:

Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age).

Treatment:

Biological: MR-Vac

Biological: Candidate Plasmodium falciparum malaria vaccine

Dietary Supplement: Vitamin A

Biological: Stamaril

Control group

Experimental group

Description:

Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age).

Treatment:

Biological: MR-Vac

Biological: Candidate Plasmodium falciparum malaria vaccine

Dietary Supplement: Vitamin A

Biological: Stamaril