Trials / Completed
CompletedNCT04893811
Trial to Describe the Safety, Tolerability, and Immunogenicity of Trumenba When Administered to Immunocompromised Participants ≥10 Years of Age
A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA(REGISTERED) WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF AGE
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 10 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic and complement-deficient individuals ≥10 years of age.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Trumenba | Bivalent recombinant lipoprotein 2086 vaccine |
Timeline
- Start date
- 2021-08-18
- Primary completion
- 2023-09-06
- Completion
- 2023-09-06
- First posted
- 2021-05-20
- Last updated
- 2024-10-16
- Results posted
- 2024-10-16
Locations
14 sites across 3 countries: Czechia, Poland, Turkey (Türkiye)
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04893811. Inclusion in this directory is not an endorsement.