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.
1 other identifier
interventional
699
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2017
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2016
CompletedFirst Posted
Study publicly available on registry
March 4, 2016
CompletedStudy Start
First participant enrolled
May 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2018
CompletedResults Posted
Study results publicly available
August 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2020
CompletedSeptember 29, 2021
September 1, 2021
10 months
February 23, 2016
March 13, 2019
September 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Anti-Circumsporozoite (Anti-CS) Antibody Concentrations, One Month Post Dose 3 of SB257049 (Primary Analysis)
Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The 95% confidence intervals were calculated using the Analysis of Variance (ANOVA) model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group.
At one month post Dose 3 of SB257049 (Month 4)
Anti-CS Antibody Concentrations, One Month Post Dose 3 of SB257049 (Study End Analysis)
Concentrations were expressed as GMCs with the following unit of measure: EU/mL. The 95% confidence intervals were calculated using the ANOVA model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group. The analysis was re-evaluated and performed on the Per-Protocol set for immunogenicity defined at study end.
At one month post Dose 3 of SB257049 (Month 4)
Secondary Outcomes (37)
Anti-CS Antibody Concentrations, Pre-vaccination and One Month Post Dose 3 of SB257049
At Day 0 and one month post Dose 3 of SB257049 (Month 4)
Number of Seropositive Subjects for Anti-CS Antibodies, Pre-vaccination and One Month Post Dose 3 of SB257049
At Day 0 and one month post Dose 3 of SB257049 (Month 4)
Anti-hepatitis B (Anti-HBs) Antibody Concentrations, Pre-vaccination and One Month Post-Dose 3 of SB257049
At Day 0 and one month post Dose 3 of SB257049 (Month 4)
Number of Seroprotected Subjects for Anti-HB Antibodies, Pre-vaccination and One Month Post-Dose 3 of SB257049
At Day 0 and one month post-Dose 3 of SB257049 (Month 4)
Number of Seroconverted Subjects for Anti-Measles (Anti-Me) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella (MeRu) Vaccine
At one month post-vaccination with the combined measles and rubella (MeRu) vaccine (Month 4)
- +32 more secondary outcomes
Study Arms (3)
Coad group
EXPERIMENTALChildren 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).
RTS,S group
EXPERIMENTALChildren 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).
Control group
EXPERIMENTALChildren 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).
Interventions
Oral administration of Vitamin A (1 dose)
Intramuscular administration of SB257049 vaccine (4 doses)
Subcutaneous injection of a combined measles and rubella vaccine (1 dose)
Intramuscular injection of a yellow fever (YF) vaccine (1 dose)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (2)
GSK Investigational Site
Kintampo, Ghana
GSK Investigational Site
Kumasi, Ghana
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2016
First Posted
March 4, 2016
Study Start
May 10, 2017
Primary Completion
March 14, 2018
Study Completion
October 7, 2020
Last Updated
September 29, 2021
Results First Posted
August 29, 2019
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.