Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006)

PHASE2CompletedINTERVENTIONAL
Enrollment

690

Participants

Timeline

Start Date

October 8, 2015

Primary Completion Date

January 20, 2016

Study Completion Date

January 20, 2016

Conditions
Pneumococcal Infections
Interventions
BIOLOGICAL

V114-A

Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).

BIOLOGICAL

V114-B

Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).

BIOLOGICAL

Prevnar 13®

Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), and 6B (4.4 mcg) in each 0.5 mL dose.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02547649 - Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006) | Biotech Hunter | Biotech Hunter