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A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

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A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2-arm Study to Investigate the Safety and Immunogenicity of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2025

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At a glance

  • Drugs SP-0202 (Primary) ; Hib-DTaP-hepatitis B-poliovirus vaccine; Measles mumps and rubella virus vaccine; Measles mumps and rubella virus vaccine; Pneumococcal 20-valent conjugate vaccine; Rotavirus W179-9 vaccine; Varicella zoster virus vaccine live; Varicella zoster virus vaccine live
  • Indications Pneumococcal infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors Sanofi Pasteur

Most Recent Events

  • 20 Mar 2025 Planned primary completion date changed to 1 Dec 2026.
  • 22 Dec 2024 Status changed from not yet recruiting to recruiting.
  • 16 Dec 2024 Status changed from planning to not yet recruiting.

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