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A Study to Evaluate the Single Vaccination of an Adenovirus Serotype 26 Pre-Fusion F (Ad26.preF) Based Respiratory Syncytial Virus (RSV) Vaccine in Japanese Adults Aged 60 Years and Older

NCT04354480 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-02-03

No results posted yet for this study

Summary

The main purpose of this study is to assess the safety and reactogenicity of the Ad26.preF based RSV vaccine administered intramuscularly as a single injection versus placebo in Japanese adults aged greater than equal to 60 years.

Conditions

  • Healthy

Interventions

BIOLOGICAL

RSV Vaccine

Participants will receive single IM injection of Ad26.preF RSV based vaccine on Day 1.

OTHER

Placebo

Participants will receive a single IM injection of matching placebo on Day 1.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-15
Primary Completion
2021-01-20
Completion
2021-01-20
FDA Drug
Yes

Countries

  • Japan

Study Locations

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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 NCT04354480 on ClinicalTrials.gov