drugset / Trial / NCT07320716
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
RandomizedParallel-groupOpen-labelPrevention
Summary
The current study is a follow-up to 2 previous parent studies, a dose-selection study with 3 different dose-levels of the altSonflex1-2-3 vaccine in a schedule of 3 vaccinations (H06\_01TP study \[NCT05073003, 212149\]) and a study with an alternate 2 vaccination schedule H06\_02TP study \[NCT06663436, 219449\]). The current study aims to assess the longevity of the immune response to the selected dose of the altSonflex1-2-3 vaccine 1, 2, and 3 years after the last vaccination in African children. The study involves no new vaccinations but will collect immunogenicity blood samples from participants.
Timeline
- Start
- 2026-01-02
- Primary completion
- 2028-10-31
- Completion
- 2028-10-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AltSonflex1-2-3 | Vaccine | — | Intramuscular |
| Comparator | Infanrix hexa | Vaccine | — | Intramuscular |
| Comparator | Menveo | Vaccine | — | Intramuscular |
| Comparator | TYPHIBEV | Vaccine | — | Intramuscular |