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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 26 Feb 2024

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At a glance

  • Drugs GSK 4001785A (Primary) ; DTaP vaccine; Meningococcal vaccine groups A C Y W-135 conjugate; Typhoid vaccine Vi-polysaccharide
  • Indications Bacillary dysentery; Shigella infections
  • Focus Adverse reactions; First in man; Pharmacodynamics
  • Acronyms SHIGELLA 4 GMMA GVGH-001 (H06_01TP)
  • Sponsors GlaxoSmithKline Biologicals; GSK

    • Most Recent Events

    • 21 Feb 2024 Planned End Date changed from 8 May 2025 to 4 Jun 2025.
    • 21 Feb 2024 Planned primary completion date changed from 8 May 2025 to 4 Jun 2025.
    • 17 Jan 2024 Planned End Date changed from 17 Apr 2025 to 8 May 2025.
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