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A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
The purpose of this study for: Cohort 1 and Cohort 2: to assess the safety and reactogenicity of the intramuscular one- and two-dose regimens, with a booster at Month 12 (Cohort 1) and to select a regimen for Cohort 3. Cohort 2 and part of Cohort 1: to assess respiratory syncytial virus (RSV) neutralizing antibody levels of the regimens containing RSV pre-fusion (preF) protein compared to the one-dose adenovirus serotype 26 respiratory syncytial virus pre-fusion (Ad26.RSV.preF) regimen. Cohort 3: to assess the safety and reactogenicity of the selected regimen and a booster at Month 12 and/or Month 24.
Details
| Lead sponsor | Janssen Vaccines & Prevention B.V. |
|---|---|
| Phase | PHASE1, PHASE2 |
| Status | COMPLETED |
| Enrolment | 669 |
| Start date | Fri Jul 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon May 16 2022 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Healthy
Interventions
- Placebo
- RSV preF Protein 50 mcg
- RSV preF Protein 150 mcg
- Ad26.RSV.preF 1*10^11 vp
- Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 50 mcg
- Mixture of Ad26.RSV.preF 5*10^10 vp Plus RSV preF Protein 150 mcg
- Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 50 mcg
- Mixture of Ad26.RSV.preF 1*10^11 vp Plus RSV preF Protein 150 mcg
- Selected Regimen
Countries
United States