NCT05633992View on ClinicalTrials.gov

Safety and Immunogenicity of V116 in Vaccine-naïve Japanese Older Adults (V116-009, STRIDE-9)

PHASE3CompletedINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

January 10, 2023

Primary Completion Date

May 24, 2023

Study Completion Date

May 24, 2023

Conditions
Pneumococcal Disease
Interventions
BIOLOGICAL

V116

Sterile 0.5 mL solution in prefilled syringe containing 4 μg of each pneumococcal polysaccharide (PnPs) antigen 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B.

BIOLOGICAL

PPSV23

Sterile 0.5 mL solution in prefilled syringe containing 25 μg of each PnPs antigen 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F.

Trial Locations (8)

532-0003

Medical Corporation Heishinkai OPHAC Hospital ( Site 1008), Osaka

565-0853

Medical Corporation Heishinkai OCROM Clinic ( Site 1003), Suita-shi

192-0071

P-One Clinic ( Site 1001), Hachiōji

160-0008

Heishinkai Medical Group ToCROM Clinic ( Site 1004), Shinjuku-ku

160-0017

Medical Corporation Shinanokai Shinanozaka Clinic ( Site 1006), Shinjuku-ku

171-0014

Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic ( Site 1005), Toshima City

812-0025

PS Clinic ( Site 1002), Fukuoka

861-4157

Nishikumamoto Hospital ( Site 1007), Kumamoto

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY