The Safety, Tolerability, and Immunogenicity Profiles of a Single Dose of V114, PNEUMOVAX® 23, or PREVNAR 13® in Adults 50 Years of Age or Older (V114-002)

NCT01513551 PHASE2 COMPLETED Results posted

The purpose of the study is to see if an investigational vaccine for Streptococcus pneumonia disease (V114) has comparable safety, tolerability, and antibody response to Pneumococcal Polysaccharide Vaccine (PNEUMOVAX® 23) and 13-valent Pneumococcal Conjugate Vaccine (PREVNAR 13®) when administered to healthy adults 50 years of age or older. The primary hypothesis is the serotype-specific immunoglobulin G (IgG) geometric mean concentrations (GMCs) as measured by the pneumococcal electrochemiluminescence (Pn ECL) assay at one month postvaccination in subjects who receive V114 will be noninferior to those measured in subjects who receive PNEUMOVAX® 23.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	PHASE2
Status	COMPLETED
Enrolment	692
Start date	Tue Mar 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Feb 15 2013 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Pneumococcal Infections

Interventions

• Pneumococcal Conjugate Vaccine (V114)
• PNEUMOVAX® 23
• PREVNAR 13®