Lot-to-lot consistency of V114 in healthy adults
Research type
Research Study
Full title
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator-controlled, Lot-to-Lot Consistency Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults 50 Years of Age or Older (PNEU-TRUE)
IRAS ID
263336
Contact name
David Lewis
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eudract number
2018-004266-33
Duration of Study in the UK
0 years, 10 months, 0 days
Research summary
Merck Sharp & Dohme is developing an investigational pneumococcal conjugate vaccine (PCV), referred to as V114, for the prevention of pneumococcal infections caused by the bacterium Streptococcus pneumoniae.
Streptococcus pneumoniae is a significant cause of disease worldwide, with clinical manifestations including pneumonia, meningitis, otitis media, sinusitis and sepsis. Adults with comorbid (other existing) conditions, particularly those immunocompromised, have a higher chance of complications and death from invasive pneumococcal disease compared to adults without the comorbid conditions.
Prevnar 13™ is a PCV approved in adults for preventing pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains/serotypes. The additional serotypes included in V114 will provide broader coverage (2 additional serotypes) against the leading serotypes associated with pneumococcal disease worldwide. V114 is designed to meet continuing needs for PCVs globally, as well as address the emergence of pneumococcal disease caused by serotypes not contained in currently licensed PCVs.
This study is conducted in healthy adults aged 50 years and above, who have not received a pneumococcal vaccine, to demonstrate the consistency of V114 with respect to the safety, tolerability and immunogenicity. This study will contribute to the overall safety database and immunogenicity profile of V114 to support initial licensure in adults. Prevnar 13™ was included as the active comparator in this study to better characterise the safety profile of
V114.Approximately 2220 participants will be randomised in a 3:3:3:1 ratio to 1 of 4 vaccination groups (approximately 667 participants per V114 arm and 220 participants in the Prevnar 13™ arm). Randomisation will be stratified by participant age at enrolment (50 to 64 years, 65 to 74 years, and ≥75 years). Approximately 50% of the participants will be ≥65 years of age.
The study is funded by Merck Sharp and Dohme Limited and will take place at 5 study centres in UK.
REC name
North West - Haydock Research Ethics Committee
REC reference
19/NW/0286
Date of REC Opinion
28 Jun 2019
REC opinion
Further Information Favourable Opinion