Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

341

Participants

Timeline

Start Date

January 28, 2014

Primary Completion Date

July 1, 2016

Study Completion Date

July 1, 2016

Conditions
Streptococcus Pneumoniae InfectionPneumococcal Infections
Interventions
BIOLOGICAL

Prevnar 13®

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

BIOLOGICAL

V114 1x:1x:1x

V114 1x:1x:1x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant (APA).

BIOLOGICAL

V114 2x:2x:2x

V114 2x:2x:2x contains 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.

BIOLOGICAL

V114 2x:1x:2x

V114 2x:1x:2x contains 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.

BIOLOGICAL

V114 1x:1x:2x

V114 1x:1x:2x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA.

BIOLOGICAL

V114 0.5x:0.5x:2x

V114 0.5x:0.5x:2x contains 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT02037984 - Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004) | Biotech Hunter | Biotech Hunter