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A Phase III Open-label Randomised Study, to Evaluate the Immunogenicity and Safety of the Concomitant Administration of V419 (PR5I) Given at 2, 3 and 4 Months of Age With Two Types of Meningococcal Serogroup C Conjugate (MCC) Vaccines Given at 3 and 4 Months of Age, and Followed by the Administration at 12 Months of Age of a Combined Haemophilus Influenzae Type b-MCC Vaccine

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Trial Profile

A Phase III Open-label Randomised Study, to Evaluate the Immunogenicity and Safety of the Concomitant Administration of V419 (PR5I) Given at 2, 3 and 4 Months of Age With Two Types of Meningococcal Serogroup C Conjugate (MCC) Vaccines Given at 3 and 4 Months of Age, and Followed by the Administration at 12 Months of Age of a Combined Haemophilus Influenzae Type b-MCC Vaccine

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 May 2022

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At a glance

  • Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Hib-meningococcal vaccine group C conjugate; Measles mumps and rubella virus vaccine; Meningococcal vaccine group C conjugate; Pneumococcal 13-valent CRM197 vaccine conjugate
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Measles; Meningococcal meningitis; Mumps; Pertussis; Pneumococcal infections; Poliomyelitis; Rubella; Tetanus
  • Focus Pharmacodynamics; Registrational
  • Sponsors MCM Vaccine; sanofi pasteur MSD

    • Most Recent Events

    • 01 Feb 2021 Results from protocol 005,006,007,008 and 011 assessing protective immune responses of DTaP-IPV-Hib-HepB vaccine against Haemophilus influenza type B, published in the Vaccine
    • 09 Jul 2020 Results published in the Vaccine
    • 21 Mar 2019 Data from 6 studies (Protocols 004, 005, 006, 007, 008, and PRI01C) were integrated and analyzed to provide a comprehensive safety profile, results published in the Pediatric Infectious Disease Journal

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