Trials / Completed
CompletedNCT04490499
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
A Hepatitis B Vaccine Challenge Study to Demonstrate the Durability of Protection Against Hepatitis B Virus Infection in Healthy Children Vaccinated Approximately 9 Years Previously With a 2- or 3-Dose Infant Series and Toddler Dose of Vaxelis®
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 207 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 8 Years – 10 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an estimation study, and no formal hypothesis testing was performed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HBVAXPRO™ | Single 0.5 mL intramuscular dose |
Timeline
- Start date
- 2020-09-02
- Primary completion
- 2020-12-29
- Completion
- 2020-12-29
- First posted
- 2020-07-29
- Last updated
- 2022-07-27
- Results posted
- 2021-09-05
Locations
10 sites across 1 country: Finland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04490499. Inclusion in this directory is not an endorsement.