drugset / Trial / NCT06817421
Opportunistic Pneumococcal Immunisation Trial in MALnutrition
Phase 4
Not yet recruiting
214 enrolled
Nick Fancourt
Murdoch Childrens Research Institute · collabThe University of Western Australia · collabTimor-Leste Ministry of Health · collabUniversity of Edinburgh · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The goal of the OPTIMAL clinical trial is to learn if a dose of a pneumococcal conjugate vaccine (PCV) generates a good immune response in young children who are in hospital with severe acute malnutrition. Researchers will compare an intervention group who get a dose of a PCV (Pneumosil) to a control group who get a dose of a Typhoid conjugate vaccine (Typbar TCV). To ensure all participants receive timely potential benefits, at 3 months participants in the intervention group with receive a dose of Typbar TCV, and those in the conrol group will receive a dose of Pneumosil. Participants will be visited 4 times at their homes over six months after vaccination, with a phone review at 12 months after vaccination.
Timeline
- Start
- 2026-01
- Primary completion
- 2028-03
- Completion
- 2029-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pneumosil | Vaccine | 0.5 ml | Intramuscular |
| Subject | Typbar-TCV | Vaccine | 0.5 ml | Intramuscular |