Trials / Completed
CompletedNCT02699099
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.
Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine (SB257049) Given at 6, 7.5 and 9 Months of Age in Co-administration With Measles, Rubella and Yellow Fever Vaccines Followed by a Booster of the Malaria Vaccine.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 699 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Months – 6 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Vitamin A | Oral administration of Vitamin A (1 dose) |
| BIOLOGICAL | Candidate Plasmodium falciparum malaria vaccine | Intramuscular administration of SB257049 vaccine (4 doses) |
| BIOLOGICAL | MR-Vac | Subcutaneous injection of a combined measles and rubella vaccine (1 dose) |
| BIOLOGICAL | Stamaril | Intramuscular injection of a yellow fever (YF) vaccine (1 dose) |
Timeline
- Start date
- 2017-05-10
- Primary completion
- 2018-03-14
- Completion
- 2020-10-07
- First posted
- 2016-03-04
- Last updated
- 2021-09-29
- Results posted
- 2019-08-29
Locations
2 sites across 1 country: Ghana
Source: ClinicalTrials.gov record NCT02699099. Inclusion in this directory is not an endorsement.