The Study
V116-010
A Phase 3, Randomised, Double-Blind, Active Comparator-Controlled Clinical Study to Evaluate the Safety, Tolerability and Immunogenicity of V116 in Pneumococcal Vaccine- Naïve Adults 50 Years of Age or Older
Study Vaccine
V116, an investigational 21-valent pneumococcal conjugate vaccine, is designed to target serotypes that account for the majority of invasive pneumococcal disease (IPD) in adults, including
8 serotypes not in currently licensed vaccines.
Study Procedures
Participants will be randomised in a blinded way to 1 of 2 groups (1:1 ratio):
• Group 1 – receives V116
• Group 2 – receives Pneumovax23®
Other study procedures include body temperature, blood tests, physical examinations, and maintaining a symptom diary.
Study Population
Approximately 1,400 participants
• ≥50 years of age
• No history of IPD or other pneumococcal infection confirmed by a positive culture within the last 3 years
• No prior administration of any pneumococcal vaccine
• Female participants of childbearing potential must not be pregnant or breastfeeding and must adhere to contraception requirements for the duration of the study and for at least 6 weeks after receiving the assigned study vaccination
Study Duration
Main study
• 2 study clinic visits
• 3 visits that will occur at the study clinic or over the phone with the study doctor or a member of the study staff
PBMC (peripheral blood mononuclear cells) sub-study at selected sites:
• Additional visit at 12 months
Immunogenicity sub-study (first 50% of participants randomised):
• Additional visits at 12 months, 18 months, 24 months
For more information or to refer a patient, please contact:
Armida Balawon: a.balawon@qmul.ac.uk | 02078825669
Francis Galera: f.galera@qmul.ac.uk | 02078825705
