Trials / Completed
CompletedNCT04440163
MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ≥10 TO <26 YEARS OF AGE
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,431 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 10 Years – 25 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ≥10 to \<26 years of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MenABCWY | N meningitidis groups A, B, C, W, and Y vaccine |
| BIOLOGICAL | Saline | Placebo |
| BIOLOGICAL | Trumenba | Bivalent recombinant lipoprotein 2086 vaccine |
| BIOLOGICAL | MenACWY-CRM | Meningococcal group A, C, W-135, and Y conjugate vaccine |
Timeline
- Start date
- 2020-06-17
- Primary completion
- 2022-07-24
- Completion
- 2022-07-24
- First posted
- 2020-06-19
- Last updated
- 2023-04-18
- Results posted
- 2023-04-18
Locations
78 sites across 5 countries: United States, Czechia, Denmark, Hungary, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04440163. Inclusion in this directory is not an endorsement.