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A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Active-Comparator-controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of a 4-dose Regimen of V114 in Healthy Infants (PNEU-PED)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2023

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At a glance

  • Drugs V 114 (Primary) ; Hepatitis A vaccine inactivated; Hepatitis B vaccine recombinant; Hib vaccine conjugate; Hib-DTaP-poliovirus vaccine; Measles mumps and rubella virus vaccine; Pneumococcal 13-valent CRM197 vaccine conjugate; Rotavirus W179-9 vaccine; Varicella zoster virus vaccine live
  • Indications Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms PNEU-PED
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 06 Jan 2023 Results assessing safety and immunogenicity of V114 and PCV13 in healthy infants published in the Vaccine
  • 22 Jun 2022 According to a Merck & Co media release, the U.S. Food and Drug Administration (FDA) has approved an expanded indication for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) to include children 6 weeks through 17 years of age. The approval follows the FDA's Priority Review of Merck's supplemental application. This approval based on data from seven trials including NCT03893448, NCT03620162, NCT03885934.
  • 22 Jun 2022 According to a Merck & Co media release, Dr. Steven Shapiro is an investigator for this trial.

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