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A Phase 3, Multicenter, Randomized, Double-blind, Active-comparato-rcontrolled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (PNEU-PED-EU-1)

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Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind, Active-comparato-rcontrolled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (PNEU-PED-EU-1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Sep 2023

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At a glance

  • Drugs V 114 (Primary) ; Hib DTaP hepatitis B poliovirus vaccine (Infanrix hexa); Pneumococcal 7-valent CRM197 vaccine conjugate; RIX 4414
  • Indications Pneumococcal infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms PNEU-PED-EU-1
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 25 Apr 2023 Results assessing the safety and immunogenicity of V114 compared with PCV13 in healthy infants, and concomitant administration with DTPa-HBV-IPV/Hib and rotavirus RV1 vaccines, published in the Vaccine.
  • 24 Oct 2022 According to a Merck & Co media release, This approval facilitates availability of VAXNEUVANCE for this population in all 27 European Union (EU) Member States plus Iceland, Norway and Lichtenstein.
  • 24 Oct 2022 According to a Merck & Co media release, based on the data from eight studies, including this study, European Commission (EC) has approved an expanded indication for VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) to include active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae (S. pneumoniae) in infants, children and adolescents from 6 weeks to less than 18 years of age.

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