Trials / Completed
CompletedNCT01537185
Phase I Safety Trial of Streptococcus Pneumoniae Whole Cell Vaccine (SPWCV) + Alum in Healthy Adults
A Phase 1 Randomized, Double-Blind, Dose-Escalation Study to Assess the Safety, Tolerability and Immunogenicity of Inactivated Streptococcus Pneumoniae Whole Cell Vaccine Formulated With Alum (SPWCV+Alum) in Healthy Adults
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- PATH Vaccine Solutions · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to determine if a Streptococcus pneumoniae Whole Cell Vaccine (SPWCV) given with alum is safe and well tolerated by healthy adults.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Placebo | 3 cohorts of normal saline injection |
| BIOLOGICAL | SPWCV+Alum 100 mcg | 3 injections 28 days apart |
| BIOLOGICAL | SPWCV+Alum 600 mcg | 3 injections 28 days apart |
| BIOLOGICAL | SPWCV+Alum 300 mcg | 3 injections 28 days apart |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2012-10-01
- Completion
- 2013-04-01
- First posted
- 2012-02-23
- Last updated
- 2014-06-05
- Results posted
- 2014-06-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01537185. Inclusion in this directory is not an endorsement.