- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04490499
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
July 20, 2022 updated by: Merck Sharp & Dohme LLC
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®
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
207
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Mellersta Osterbotten
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Kokkola, Mellersta Osterbotten, Finland, 67100
- Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)
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Pirkanmaa
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Tampere, Pirkanmaa, Finland, 33100
- Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
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Pohjanmaa
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Seinajoki, Pohjanmaa, Finland, 60100
- Seinajoki Vaccine Research Center ( Site 0010)
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Pohjois-Pohjanmaa
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Oulu, Pohjois-Pohjanmaa, Finland, 90220
- Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
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Satakunta
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Pori, Satakunta, Finland, 28100
- Porin rokotetutkimusklinikka ( Site 0008)
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Uusimaa
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Espoo, Uusimaa, Finland, 02230
- Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
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Helsinki, Uusimaa, Finland, 00100
- Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)
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Helsinki, Uusimaa, Finland, 00930
- Ita-Helsingin Rokotetutkimuskeskus ( Site 0006)
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Jarvenpaa, Uusimaa, Finland, 04400
- Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
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Varsinais-Suomi
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Turku, Varsinais-Suomi, Finland, 20520
- Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 10 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HBVAXPRO™
Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who will receive a single dose of Hepatitis B vaccine challenge (HBVAXPRO™).
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Single 0.5 mL intramuscular dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a Protective Hepatitis B Surface Antibody Level of ≥10 Milli International Units/mL (mIU/mL) at 30 Days Post-Challenge With HBVAXPRO™
Time Frame: Day 30
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Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg).
Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge.
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Day 30
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen
Time Frame: Day 1 and Day 30
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Participant serum samples will be assessed with an ECi assay for anti-HBs geometric mean concentrations (GMCs) pre-challenge on Day 1 and 30 days post-challenge with HBVAXPRO™ in mIU/mL.
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Day 1 and Day 30
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 2, 2020
Primary Completion (Actual)
December 29, 2020
Study Completion (Actual)
December 29, 2020
Study Registration Dates
First Submitted
July 28, 2020
First Submitted That Met QC Criteria
July 28, 2020
First Posted (Actual)
July 29, 2020
Study Record Updates
Last Update Posted (Actual)
July 27, 2022
Last Update Submitted That Met QC Criteria
July 20, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- V419-013 (Other Identifier: Merck)
- 2020-000126-26 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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