NCT03303625View on ClinicalTrials.gov

A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

November 29, 2017

Primary Completion Date

April 21, 2020

Study Completion Date

April 21, 2020

Conditions
Respiratory Syncytial VirusesRespiratory Tract Infections
Interventions
BIOLOGICAL

Ad26.RSV.preF (1*10^11 vp)

Participants will receive two doses of 0.5 milliliter (mL) (1\*10\^11 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.

BIOLOGICAL

Ad26.RSV.preF (5*10^10 vp)

RSV seropositive participants will receive two doses of 0.25 mL (5\*10\^10 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.

DRUG

Placebo

Participants will receive either 0.5 mL (cohort 0) or 0.25 mL (cohort 1) of placebo via IM route on Day 1 and 29.

Trial Locations (7)

20520

University of Tampere/Vaccine Research Center, Turku

33100

University of Tampere/Vaccine Research Center, Tampere

67114

Heartland Research Associates, LLC, Newton

04400

Järvenpään rokotetutkimusklinikka, Järvenpää

M13 9WL

Royal Manchester Children's Hospital, Manchester

OX3 7LE

Oxford Vaccine Group, Oxford

SO166YD

University Hospital Southampton NHS Foundation Trust, Southampton

All Listed Sponsors
lead

Janssen Vaccines & Prevention B.V.

INDUSTRY

NCT03303625 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age | Biotech Hunter | Biotech Hunter