NCT03339713

A Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and an Adenovirus Serotype 26- Based Vaccine Encoding for the Respiratory Syncytial Virus Pre-fusion F Protein (Ad26.RSV.preF), With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health

A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate the Safety and Immunogenicity of Seasonal Influenza Vaccine and Ad26.RSV.preF, With and Without Co-administration, in Adults Aged 60 Years and Older in Stable Health

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Janssen Vaccines & Prevention B.V. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to demonstrate the non-inferiority of the concomitant administration of an adenovirus serotype 26- based vaccine encoding for the respiratory syncytial virus pre-fusion F protein (Ad26.RSV.preF) and seasonal influenza vaccine versus the administration of seasonal influenza vaccine alone in terms of humoral immune response expressed by the geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibody titers against all four influenza vaccine strains 28 days after the administration of influenza vaccine, and to assess the safety and tolerability of a single dose of 1\*10\^11 viral particles (vp) of Ad26.RSV.preF, administered intramuscularly to participants aged greater than or equal to 60 years separately or concomitantly with seasonal influenza vaccine.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	Ad26.RSV.preF	Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1\*10\^11 vp.
BIOLOGICAL	Fluarix	Fluarix will be administered as intramuscular injection.
BIOLOGICAL	Placebo	Placebo will be administered as intramuscular injection of sterile 0.9 percent (%) saline for injection.

Timeline

• Start date: 2017-12-07
• Primary completion: 2018-07-23
• Completion: 2018-07-23
• First posted: 2017-11-13
• Last updated: 2025-02-04
• Results posted: 2021-08-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study