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A Phase I Randomized, Observer-blind, Controlled, Dose Escalation Trial of the Safety and Tolerability of Two Intramuscular Doses of DPX-RSV(A), a Respiratory Syncytial Virus Vaccine Containing Respiratory Syncytial Virus (RSV) SHe Antigen and a Novel Adjuvant DepoVaxTM, or SHe A Antigen Co-administered With Aluminum Hydroxide, or Placebo to Healthy Adults ≥50-64 Years of Age
Administration of DPX-RSV(A), a Respiratory Syncytial Virus vaccine containing Respiratory Syncytial Virus (RSV) SHe antigen and DepoVaxTM adjuvant to healthy adults ≥50-64 years of age.
Details
| Lead sponsor | Dalhousie University |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2015-05 |
| Completion | 2017-03-14 |
Conditions
- Respiratory Syncytial Virus
Interventions
- DPX-RSV(A)
- RSV(A)-Alum
- Placebo
Primary outcomes
- Number of participants with adverse events as a measure of safety and reactogenicity of the intramuscular DPX-RSV(A) — Up to 28 Days after first injection.
Countries
Canada