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A Phase 1 Randomized, Open-label, Parallel-group, Active- And Placebo-controlled Study To Assess Safety And Tolerability Of 60, 120, And 200 Mcg Meningococcal Group B Rlp2086 Vaccine In Healthy Adult Subjects
The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.
Details
| Lead sponsor | Pfizer |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 48 |
| Start date | 2009-04 |
| Completion | 2012-07 |
Conditions
- Meningitis, Meningococcal
Interventions
- rLP2086 vaccine or control
- rLP2086 vaccine or control
- rLP2086 vaccine or control
- rLP2086 vaccine or control
Primary outcomes
- Percentage of Participants With at Least One Adverse Event (AE) — Baseline up to Month 7
- Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT]) — Baseline up to Month 7
- Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST]) — Baseline up to Month 7
- Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein) — Baseline up to Month 7
- Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin) — Baseline up to Month 7
- Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP]) — Baseline up to Month 7
Countries
United States