Efficacy, Safety and Immunogenicity Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Evaluating Schedules With or Without Fractional Doses, Early Dose 4 and Yearly Doses, in Children 5-17 Months of Age

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-28

Study Completion Date

2022-11-14

Brief Summary

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The study intends to establish proof of concept for a fractional dose schedule under conditions of natural exposure in children 5-17 months old at first vaccination. The study also aims to establish the role of third dose spacing in a fractional dose schedule, describe the effect of an earlier full fourth dose at Month 14 and describe the effect of multiple fractional or full yearly doses.

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Detailed Description

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The current study intends to establish proof of concept (POC) for a fractional dose schedule under conditions of natural exposure. The study will be conducted in children 5-17 months old at first vaccination living in areas of mid to high malaria transmission, in line with the age group recommended by the World Health Organization (WHO) for the implementation of the RTS,S/AS01E vaccine. Results from this study will be critical in informing future possibilities for the development of vaccine-based strategies which, in combination with other interventions, may contribute to the malaria elimination agenda.

Conditions

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Malaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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R012-20 Group

Participants will receive a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and at Month 20.

Group Type EXPERIMENTAL

RTS,S/AS01E (Full dose)

Intervention Type BIOLOGICAL

Participants will receive intramuscular injection of RTS,S/AS01E (full dose: 0.5 ml).

R012-14-mD Group

Participants will receive a full dose of RTS,S/AS01E at Month 0, Month 1, Month 2 and yearly full doses at Month 14, Month 26 and Month 38.

Group Type EXPERIMENTAL

RTS,S/AS01E (Full dose)

Intervention Type BIOLOGICAL

Participants will receive intramuscular injection of RTS,S/AS01E (full dose: 0.5 ml).

Fx012-14-mFxD Group

Participants will receive a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 2 and yearly fractional doses at Month 14, Month 26 and Month 38.

Group Type EXPERIMENTAL

RTS,S/AS01E (Full dose)

Intervention Type BIOLOGICAL

Participants will receive intramuscular injection of RTS,S/AS01E (full dose: 0.5 ml).

RTS,S/AS01E (1/5th dose)

Intervention Type BIOLOGICAL

Participants will receive intramuscular injection of RTS,S/AS01E (1/5th dose: 0.1 ml).

Fx017-mFxD Group

Participants will receive a full dose of RTS,S/AS01E at Month 0 and Month 1, and RTS,S/AS01E 1/5th dose at Month 7 and yearly fractional doses at Month 20 and Month 32.

Group Type EXPERIMENTAL

RTS,S/AS01E (Full dose)

Intervention Type BIOLOGICAL

Participants will receive intramuscular injection of RTS,S/AS01E (full dose: 0.5 ml).

RTS,S/AS01E (1/5th dose)

Intervention Type BIOLOGICAL

Participants will receive intramuscular injection of RTS,S/AS01E (1/5th dose: 0.1 ml).

Control Group

Participants will receive rabies vaccine at Month 0, Month 1 and Month 2.

Group Type EXPERIMENTAL

Rabies vaccine

Intervention Type BIOLOGICAL

Participants will receive intramuscular injection of rabies vaccine (0.1 ml).

Interventions

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RTS,S/AS01E (Full dose)

Participants will receive intramuscular injection of RTS,S/AS01E (full dose: 0.5 ml).

Intervention Type BIOLOGICAL

RTS,S/AS01E (1/5th dose)

Participants will receive intramuscular injection of RTS,S/AS01E (1/5th dose: 0.1 ml).

Intervention Type BIOLOGICAL

Rabies vaccine

Participants will receive intramuscular injection of rabies vaccine (0.1 ml).

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Participants' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits).
* Signed or thumb-printed and witnessed informed consent obtained from the parent(s)/LAR(s) of the participant prior to performance of any study specific procedure. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by an independent witness.
* A male or female between, and including, five and 17 months of age at the time of the first vaccination.
* Healthy participants as established by medical history and clinical examination before entering into the study.
* Previously received three documented doses of diphtheria, tetanus, pertussis, hepatitis B vaccine (DTPHepB), and at least three doses of oral polio vaccine.

Exclusion Criteria

* Child in care.
* Use of a drug or vaccine that is not approved for that indication (by one of the following regulatory authorities: Food and Drug Administration \[FDA; USA\] or European Union member state or WHO \[with respect to prequalification\]) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 0), or planned use during the study period.
* Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (0.5 mg/kg/day (for pediatric participants) or equivalent. Inhaled and topical steroids are allowed.
* Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before each dose and ending seven days after each dose of vaccine administration.
* Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
* Family history of congenital or hereditary immunodeficiency.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
* History of anaphylaxis post-vaccination.
* History of any, or documented, serious adverse reaction to rabies vaccination.
* Contraindication to rabies vaccination (Rabipur is contraindicated in participants with history of a severe hypersensitivity to any of the ingredients in the vaccine. Note that the vaccine contains polygeline and residues of chicken proteins, and may contain traces of neomycin, chlortetracycline and amphotericin B).
* Major congenital defects.
* Serious chronic illness.
* Children with a past history of a neurological disorder or atypical febrile seizure (a febrile seizure is atypical if it meets one of the following criteria: not associated with fever; lasts \> 5 minutes; focal (not generalized); followed by transient or persistent neurological abnormality; occurs in a child \< 6 months of age).
* Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 37.5°C/99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C/100.4°F for rectal route.

Participants with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.

* Administration of immunoglobulins and/or any blood products during the period starting three months before the first dose of study vaccine or planned administration during the study period.
* Moderate or severe malnutrition at screening defined as weight for age or weight for height Z-score \< -2.
* Hemoglobin concentration \< 8 g/dl at screening.
* Same sex twins (to avoid misidentification).
* Maternal death.
* Prior receipt of an investigational malaria vaccine.

Minimum Eligible Age

5 Months

Maximum Eligible Age

17 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes