NCT05420961

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)

A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 717 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.

Detailed description

Participants will be randomized to 1 of 3 cohorts depending upon prior vaccinations. Prior vaccinations by cohort include: PPSV23 (pneumococcal vaccine, polyvalent \[23-valent\], PNEUMOVAX™23) for Cohort 1; PCV13 (pneumococcal 13-valent conjugate vaccine; PREVNAR 13™) for Cohort 2; PCV15 (pneumococcal 15-valent conjugate vaccine; VAXNEUVANCE™), PCV20 (pneumococcal 20-valent conjugate vaccine; PREVNAR 20™), PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 for Cohort 3.

Conditions

• Pneumonia, Pneumococcal

Interventions

Type	Name	Description
BIOLOGICAL	V116	Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
BIOLOGICAL	PCV15	Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension
BIOLOGICAL	PPSV23	Pneumococcal 23-valent vaccine with 25 μg of each of the 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 in each 0.5 mL sterile solution

Timeline

• Start date: 2022-07-12
• Primary completion: 2023-05-16
• Completion: 2023-05-16
• First posted: 2022-06-16
• Last updated: 2024-10-26
• Results posted: 2024-05-01

Locations

51 sites across 9 countries: United States, Canada, France, Israel, Italy, Japan, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study