NCT02561871View on ClinicalTrials.gov

A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

September 30, 2015

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2016

Conditions
Respiratory Syncytial VirusesRespiratory Tract Infections
Interventions
BIOLOGICAL

Ad26.RSV.FA2

Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on day 1 and 85 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10\^10 virus particles \[vp\]) on day 1 in Group 2.

BIOLOGICAL

Ad35.RSV.FA2

Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10\^11 virus particles \[vp\]) on day 169 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10\^11 virus particles \[vp\]) on day 85 in Group 2.

DRUG

Placebo

Participants will receive Intramuscular injection of Placebo control on day 169 in Group 2. Intramuscular injection of Placebo control on day 1, 85 and 169 in Group 3.

Trial Locations (1)

Unknown

Miami

All Listed Sponsors
lead

Crucell Holland BV

INDUSTRY

NCT02561871 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of Ad26.RSV.FA2 Followed by Ad35.RSV.FA2 in Healthy Adult Volunteers | Biotech Hunter | Biotech Hunter