Safety and Immunogenicity of V116 in Adults 50 Years of Age or Older
Research type
Research Study
Full title
A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naive Adults 50 Years of Age or Older
IRAS ID
1006383
Contact name
- -
Contact email
N/A
Sponsor organisation
Merck Sharp & Dohme LLC
Eudract number
2022-001785-35
Clinicaltrials.gov Identifier
Research summary
Streptococcus pneumoniae is a major cause of vaccine-preventable disease worldwide. Despite the public health impact of currently available pneumococcal vaccines, pneumococcal disease in adults remains a significant unmet medical need.
This trial is testing an experimental injectable vaccine, V116, compared to the injectable vaccine PNEUMOVAX™ 23 in adults who have not previously received any pneumococcal vaccine (vaccine-naïve). PNEUMOVAX™ 23, also called PPSV23, is approved for preventing pneumococcal disease. V116 is designed to provide significantly broader pneumococcal disease coverage in adults, as compared with currently licensed pneumococcal vaccines.
Approximately 1400 male and female participants aged 50 years or older will take part in this trial.
Participants will be screened at their first clinical visit to see if they can join the trial.
Eligible participants will be randomly put into two different groups (randomised) to receive a single dose of either V116 or PNEUMOVAX™ 23.
Once the participant receives the vaccination at the trial site, they will move into follow-up.Depending on when the participant joins the trial, they be in the trial for 6 months, visiting the trial site a total of about 2 to 4 times, or 24 months (about 2 years), visiting the trial site a total of about 5 to 7 times.
The trial is sponsored by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (MSD).
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
22/EM/0219
Date of REC Opinion
21 Nov 2022
REC opinion
Further Information Favourable Opinion