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A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months (V419-007-03)

Trial Profile

A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months (V419-007-03)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 May 2022

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At a glance

  • Drugs Hib-DTaP-hepatitis B-poliovirus vaccine (Primary) ; Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa); MMR-varicella zoster virus vaccine; Pneumococcal 13-valent CRM197 vaccine conjugate; Rotavirus W179-9 vaccine
  • Indications Diphtheria; Haemophilus infections; Hepatitis B; Pertussis; Poliomyelitis; Tetanus
  • Focus Pharmacodynamics; Therapeutic Use
  • 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
    • 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
    • 27 Nov 2018 Result analysis from NCT00362427, NCT01337167, NCT01340937, NCT01341639, NCT01480258, NCT01553279, providing a comprehensive safety profile, published in the Pediatric Infectious Disease Journal.
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