WHO ICTRP trial
A study on the safety and immune responses to the GVGH altSonflex1-2-3 vaccine…
EUCTR2021-000891-12-BE · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2021-000891-12-BE |
|---|---|
| Public title | A study on the safety and immune responses to the GVGH altSonflex1-2-3 vaccine against shigellosis in adults, children, and infants |
| Scientific title | A staged Phase I/II observer-blind, randomised, controlled, multi-country study to evaluate the safety, reactogenicity, and immune responses to the GVGH altSonflex1-2-3 vaccine against S. sonnei and S. flexneri, serotypes 1b, 2a, and 3a, in adults in Europe (Stage 1) followed by age de-escalation… |
| Primary sponsor | GlaxoSmithKline Biologicals |
| Registry | EU Clinical Trials Register |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | Kenya;Belgium |
| Conditions | Prophylaxis for Shigellosis induced by Shigella sonnei, Shigella flexneri 1b, Shigella flexneri 2a and Shigella flexneri 3a. MedDRA version: 20.0 Level: HLT Classification code 10040550 Term: Shigella infections System Organ Class: 10021881… |
| Interventions | Product Name: Shigella sonnei, Shigella flexneri 1b, 2a, 3a GMMA vaccine Product Code: altSonflex1-2-3 (GSK4001785A) Pharmaceutical Form: Suspension for injection INN or Proposed INN: Not applicable Current Sponsor code: Shigella sonnei… |
| Registration date | Aug 26, 2021 |
| Target size | 550 |
| Secondary IDs | 212149 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: