NCT01215175

Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001)

A Multicenter, Double-Blind Study of the Safety, Tolerability, and Immunogenicity of Pneumococcal Conjugate Vaccine (V114) Compared to Prevnar™ in Healthy Adults and Toddlers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 12 Months – 45 Years
• Healthy volunteers: Accepted

Summary

This study is being conducted to evaluate the safety, tolerability, and immunogenicity of 15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and toddlers.

Detailed description

The study was extended to obtain additional sera from adult participants to support further development, validation, and performance of anti-pneumococcal antibody assays.

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Prevnar™	13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
BIOLOGICAL	V114, Aluminum Adjuvanted	15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
BIOLOGICAL	V114, Aluminum Nonadjuvanted	15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) in each 0.5 mL dose.

Timeline

• Start date: 2009-09-25
• Primary completion: 2010-04-16
• Completion: 2011-01-05
• First posted: 2010-10-06
• Last updated: 2019-03-18
• Results posted: 2019-03-18