NCT02440035View on ClinicalTrials.gov

A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad35.RSV.FA2 Regimens Boosted With Ad26.RSV.FA2 in Healthy Adult Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

April 21, 2015

Primary Completion Date

June 9, 2016

Study Completion Date

June 9, 2016

Conditions
Healthy Participants
Interventions
BIOLOGICAL

Ad35.RSV.FA2

Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10\^11) virus particles on Day 1 and 85 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10\^11) virus particles on Day 1 and 169 in Group 2. Intramuscular injection of Ad35.RSV.FA2 (1x10\^11) virus particles on Day 1 in Group 3.

BIOLOGICAL

Ad26.RSV.FA2

Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on Day 169 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10\^10) virus particles on Day 169 in Group 3. Intramuscular injection of Ad26.RSV.FA2 (5x10\^10) virus particles on Day 169 in Group 4.

DRUG

Placebo

Participants will receive intramuscular injection of placebo (sterile formulation buffer) on Day 85 in Group 2. One intramuscular injections of placebo on Day 85 in Group 3. Two intramuscular injections of placebo on Day 1, and Day 85 in Group 4.

Trial Locations (1)

Unknown

Miami

All Listed Sponsors
lead

Crucell Holland BV

INDUSTRY

NCT02440035 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad35.RSV.FA2 Regimens Boosted With Ad26.RSV.FA2 in Healthy Adult Participants | Biotech Hunter | Biotech Hunter