Status:
COMPLETED
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis B
Eligibility:
All Genders
8-10 years
Phase:
PHASE3
Brief 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,...
Eligibility Criteria
Inclusion
- Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator.
- Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or participated in Protocol V419-008 and received a 2 + 1 Vaxelis® schedule.
- The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study.
Exclusion
- Has a history of diagnosis (clinical, serological, or microbiological) of HBV infection.
- Has a known or suspected impairment of immunological function (e.g., human immunodeficiency virus (HIV), splenectomy).
- Has a known hypersensitivity to any component of the study vaccine.
- Has a known or suspected blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic system.
- Has a bleeding disorder contraindicating intramuscular vaccinations.
- Has received any hepatitis B vaccine after participation in Protocol V419-007 or V419-008.
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Key Trial Info
Start Date :
September 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2020
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT04490499
Start Date
September 2 2020
End Date
December 29 2020
Last Update
July 27 2022
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)
Kokkola, Keski-Pohjanmaa, Finland, 67100
2
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
Oulu, North Ostrobothnia, Finland, 90220
3
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
Tampere, Pirkanmaa, Finland, 33100
4
Seinajoki Vaccine Research Center ( Site 0010)
Seinajoki, Pohjanmaa, Finland, 60100