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

  • STATUS
    Not Recruiting
  • participants needed
    48
  • sponsor
    Janssen Vaccines & Prevention B.V.
Updated on 2 December 2021
Investigator
The Medical Research Network, LLC
Primary Contact
Hosp. Clinico Univ. de Santiago (1.3 mi away) Contact
+75 other location
adenovirus
adenovirus serotype

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.

Description

RSV is considered the most important cause of serious acute respiratory illness in children under 5 years of age. Ad26.RSV.preF (JNJ-64400141) investigational vaccine is a replication-incompetent serotype 26 adenoviral vector (Ad26) containing a deoxyribonucleic acid (DNA) transgene that encodes for the F protein derived from the respiratory syncytial virus (RSV) A2 strain stabilized in the pre-fusion conformation (Ad26.RSV.preF). The study will evaluate whether Ad26.RSV.preF is safe, well-tolerated, and immunogenic in RSV-seronegative toddlers. The study will have 3 phases: a screening phase (up to 6 weeks before the first dose), a vaccination phase (34 weeks), and a safety follow-up phase through 2 RSV seasons after the first dose. RSV infection will be monitored by active and passive surveillance. The total duration of the study will be approximately 26 months.

Details
Condition Respiratory syncytial virus, Respiratory Syncytial Virus (RSV) Infection
Treatment Placebo, Ad26.RSV.preF, Nimenrix
Clinical Study IdentifierNCT03606512
SponsorJanssen Vaccines & Prevention B.V.
Last Modified on2 December 2021

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