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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

NCT03303625 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-05-25

Study results available
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Summary

The purpose of this study is to assess the safety and tolerability of an intramuscular regimen of two doses (1\*10\^11 viral particles \[vp\]) of an investigational respiratory syncytial virus (RSV) vaccine candidate (adenovirus serotype 26 respiratory syncytial virus pre-fusion conformation stabilized F protein \[pre-F\] \[Ad26.RSV.preF\]) in adults aged 18 to 50 years and RSV-seropositive toddlers aged 12 to 24 months.

Conditions

  • Respiratory Syncytial Viruses
  • Respiratory 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.

Sponsors & Collaborators

  • Janssen Vaccines & Prevention B.V.

    lead INDUSTRY

Principal Investigators

  • Janssen Vaccines & Prevention B.V. Clinical Trial · Janssen Vaccines & Prevention B.V.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-29
Primary Completion
2020-04-21
Completion
2020-04-21
FDA Drug
Yes

Countries

  • United States
  • Finland
  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03303625 on ClinicalTrials.gov