A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
NCT ID: NCT04490499
Last Updated: 2022-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
207 participants
INTERVENTIONAL
2020-09-02
2020-12-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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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™).
HBVAXPRO™
Single 0.5 mL intramuscular dose
Interventions
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HBVAXPRO™
Single 0.5 mL intramuscular dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
8 Years
10 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009)
Kokkola, Keski-Pohjanmaa, Finland
Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004)
Oulu, North Ostrobothnia, Finland
Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001)
Tampere, Pirkanmaa, Finland
Seinajoki Vaccine Research Center ( Site 0010)
Seinajoki, Pohjanmaa, Finland
Porin rokotetutkimusklinikka ( Site 0008)
Pori, Satakunta, Finland
Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002)
Turku, Southwest Finland, Finland
Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007)
Espoo, Uusimaa, Finland
Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005)
Helsinki, Uusimaa, Finland
Ita-Helsingin Rokotetutkimuskeskus ( Site 0006)
Helsinki, Uusimaa, Finland
Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003)
Järvenpää, Uusimaa, Finland
Countries
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References
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Ahonen A, Zhang Y, Marcek T, Lumley J, Johnson DR, Guris D, Wilck MB. Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously. Hum Vaccin Immunother. 2022 Nov 30;18(5):2073747. doi: 10.1080/21645515.2022.2073747. Epub 2022 Jun 2.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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V419-013
Identifier Type: OTHER
Identifier Source: secondary_id
2020-000126-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V419-013
Identifier Type: -
Identifier Source: org_study_id
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