The Study


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: | 02078825669

Francis Galera: | 02078825705

STRIDE-10 Study Prescreener

The following questions apply to the person interested in participating in the trial.