Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001)

PHASE1CompletedINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

November 25, 2013

Primary Completion Date

April 19, 2016

Study Completion Date

March 14, 2017

Conditions
Cytomegalovirus Infections
Interventions
BIOLOGICAL

V160 Low Dose IM

V160 administered as a 0.75 mL intramuscular injection

BIOLOGICAL

V160 Medium Dose IM

V160 administered as a 0.75 mL intramuscular injection

BIOLOGICAL

V160 High Dose IM

V160 administered as a 0.75 mL intramuscular injection

BIOLOGICAL

V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM

V160 plus MAPA administered as a 0.75 mL intramuscular injection

BIOLOGICAL

V160 High Dose plus MAPA 225 µg /dose IM

V160 plus MAPA administered as a 0.75 mL intramuscular injection

BIOLOGICAL

V160 Maximum Dose IM

V160 administered as a 0.75 mL intramuscular injection

OTHER

Placebo IM

Placebo administered as a 0.75 mL intramuscular injection

BIOLOGICAL

V160 Medium Dose ID

V160 administered as a 0.1 mL intradermal injection

OTHER

Placebo ID

Placebo administered as a 0.1 mL intradermal injection

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT01986010 - Safety, Tolerability, and Immunogenicity of the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001) | Biotech Hunter | Biotech Hunter