NCT02573181

Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007)

A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Adults 65 Years of Age or Older Previously Vaccinated With 23-Valent Pneumococcal Polysaccharide Vaccine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 253 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

This study is designed to assess the safety, tolerability, and immunogenicity of V114 compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated with 23-valent pneumococcal polysaccharide vaccine.

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	V114	V114 contains 2 µg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4 μg of serotype 6B; and 30 µg of CRM₁₉₇ and 125 µg of Aluminum Phosphate Adjuvant (APA) per 0.5 mL dose.
BIOLOGICAL	Prevnar 13™	Prevnar 13™ contains 2.2 μg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and 4.4 μg of serotype 6B; and 34 μg of CRM₁₉₇ and 125 μg of aluminum per 0.5mL dose.

Timeline

• Start date: 2015-10-30
• Primary completion: 2016-01-28
• Completion: 2016-01-28
• First posted: 2015-10-09
• Last updated: 2019-08-14
• Results posted: 2019-08-14