An Ancillary Study Protocol to GSK's Phase IIb Malaria Vaccine Trial Entitled "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"

• Register: ClinicalTrials.gov
• Last refreshed on: 4 March 2024
• Main ID: NCT03281291
• Date of registration: 11/09/2017
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: An Ancillary Study Protocol to GSK's Phase IIb Malaria Vaccine Trial Entitled "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"
• Scientific title: An Ancillary Study Protocol to GlaxoSmithKline Phase IIb RTS,S/AS01E Malaria Vaccine Trial (Study Number 204889 [MALARIA-094]) Entitled, "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"
• Date of first enrolment: November 19, 2018
• Target sample size: 1500
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03281291
• Study type: Observational

Countries of recruitment

Ghana, Kenya

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects' 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 subject 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 subjects 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 subjects) 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 subject 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 subjects with an
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.

- Subjects 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.



Age minimum: 5 Months
Age maximum: 17 Months
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Primary Outcome(s)

Time to the first new malaria infection. [Time Frame: Up to 20 months post Dose 1]

Number of new malaria infections during a specified follow-up period. [Time Frame: Up to 20 months post Dose 1]

Secondary ID(s)

206213

Source(s) of Monetary Support

Please refer to primary and secondary sponsors