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A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age

NCT03606512 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-02-04

Study results available
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Summary

The purpose of this study is to assess the safety and reactogenicity of an intramuscular regimen of 3 doses of 2.5\*10\^10 viral particles (vp) of adenovirus serotype 26 based respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative toddlers aged 12 to 24 months.

Conditions

Interventions

BIOLOGICAL

Ad26.RSV.preF

Ad26.RSV.preF will be administered as IM injection at a dose of 2.5\*10\^10 vp.

BIOLOGICAL

Placebo

Placebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection.

BIOLOGICAL

Nimenrix

Nimenrix will be administered as 0.5 milliliter (mL) solution for IM injection.

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
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-21
Primary Completion
2021-11-02
Completion
2021-11-02
FDA Drug
Yes

Countries

  • Australia
  • Brazil
  • Canada
  • Finland
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

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 NCT03606512 on ClinicalTrials.gov