A Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860

PHASE2CompletedINTERVENTIONAL
Enrollment

848

Participants

Timeline

Start Date

November 12, 2015

Primary Completion Date

September 12, 2016

Study Completion Date

June 21, 2019

Conditions
Healthy
Interventions
BIOLOGICAL

ExPEC4V (4 : 4 : 4 : 4)

Participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 4) as an intramuscular (i.m) injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in microgram \[mcg\]) from the ExPEC serotypes O1A, O2, O6A, and O25B.

BIOLOGICAL

ExPEC4V (4 : 4 : 4 : 8)

Participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 8) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.

BIOLOGICAL

ExPEC4V (8 : 8 : 8 : 8)

Participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 8) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.

BIOLOGICAL

ExPEC4V (8 : 8 : 8 : 16)

Participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 16) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.

BIOLOGICAL

ExPEC4V (16 : 16 : 16 : 16)

Participants will receive single vaccination of ExPEC4V dose (16 : 16 : 16 : 16) as an i.m injection into deltoid muscle in part 1 (age groups \>=18 to \<50 years and \>=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.

DRUG

Placebo

Participants will receive matching placebo (Tris-buffered saline) to ExPEC4V.

Trial Locations (17)

Unknown

Mesa

Hollywood

Leesburg

Miami

Boise

Wichita

Bardstown

Baltimore

Saint Paul

Kansas City

Las Vegas

Cary

Raleigh

Cincinnati

Knoxville

Austin

Houston

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT02546960 - A Study in Healthy Adults to Evaluate the Safety and Immunogenicity of Different Doses of JNJ-63871860 | Biotech Hunter | Biotech Hunter