At a glance
ClinicalIndex Comparison Record- ✓Age 60 years or older
- ✓In good or stable health; may have controlled chronic conditions (hypertension, type 2 diabetes, hyperlipoproteinemia, hypothyroidism) with stable medication dose ≥12 weeks
- ✓For women: postmenopausal (no menses for 12 months) or not intending to conceive
- ✓Normal physical examination, medical history, vital signs, and 12-lead ECG on Day 1
- ✕Acute illness or temperature ≥38.0°C within 24 hours prior to first dose
- ✕Serious chronic disorder: severe COPD, clinically significant congestive heart failure, requirement for supplemental oxygen, end stage renal disease, clinically unstable cardiac disease, Alzheimer's disease
- ✕History of malignancy within 5 years (except nonmelanoma skin cancer or cervical carcinoma in situ)
- ✕Major surgery within 4 weeks before dosing or planned during study participation or within 6 months after final dose
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Ad26.RSV.preF, Fluarix, and 1 other intervention for Healthy. Completed, enrolled 180 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1\*10\^11 vp.
Fluarix will be administered as intramuscular injection.
Placebo will be administered as intramuscular injection of sterile 0.9 percent (%) saline for injection.