A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study for Safety and Immunogenicity Evaluations 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
Phase of Trial: Phase I
Latest Information Update: 04 Dec 2018
At a glance
- Drugs JNJ 64400141 (Primary) ; JNJ-64213175 (Primary) ; GSK 2321138A
- Indications Respiratory syncytial virus infections
- Focus Adverse reactions; Pharmacodynamics
- Sponsors Janssen Vaccines and Prevention B.V
- 27 Nov 2018 Planned primary completion date changed from 22 Oct 2018 to 30 Apr 2021.
- 23 Oct 2018 Number of arms has been reduced. Planned patient number has increased.
- 23 Oct 2018 Planned number of patients changed from 562 to 667.