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Clinical trial

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 From Adults to Children and Infants, and Dose-finding in Infants in Africa (Stage 2)

NCT05073003 is registered in ClinicalTrials.gov with GlaxoSmithKline as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

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 From Adults to Children and Infants, and Dose-finding in Infants in Africa (Stage 2)
Lead sponsor
GlaxoSmithKline
Phase
Phase 1/2
Overall status
Completed
Start date
October 6, 2021
Completion date
June 24, 2025
Enrollment
551 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

diarrhoea