Trials / Completed
CompletedNCT04440176
A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules
A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ≥11 TO <15 YEARS OF AGE
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 309 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 11 Years – 14 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MenABCWY | Neisseria meningitidis group A, B, C, W, and Y vaccine |
| BIOLOGICAL | Saline | Placebo |
Timeline
- Start date
- 2020-06-17
- Primary completion
- 2024-01-05
- Completion
- 2024-01-05
- First posted
- 2020-06-19
- Last updated
- 2025-01-08
- Results posted
- 2025-01-08
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04440176. Inclusion in this directory is not an endorsement.