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A Phase 3 Clinical Trial to Evaluate Long-term Immunogenicity and Boostability of Purified Chick-Embryo Cell Rabies Vaccine in Adults Following Primary Series of Pre/Exposure Prophylaxis.

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Disease Information

Descriptive Information
Brief Title † A Phase 3 Clinical Trial to Evaluate Long-term Immunogenicity and Boostability of Purified Chick-Embryo Cell Rabies Vaccine in Adults Following Primary Series of Pre/Exposure Prophylaxis.
Official Title † A Phase 3, Open-label, Multicenter Study to Evaluate Long-term Immunogenicity and Boostability of Immune Responses in Adults Who Received Different Primary Vaccination Regimens of Pre-exposure Prophylaxis With Purified Chick-Embryo Cell Rabies Vaccine Administered Concomitantly or Separately From a Japanese Encephalitis Vaccine.
Brief Summary The aim of this study is to evaluate the long-term (up to approx.10 years) persistence and to assess the boostability of immune responses in subjects who received a primary series of accelerated or conventional rabies PrEP IM regimen.
Detailed Description
Study Phase Phase 3
Study Type † Interventional
Study Design †
Primary Outcome Measure † The primary immunogenicity endpoints will be based on the concentrations at Year 3, following a primary series of accelerated or conventional rabies PrEP IM regimen, as measured by rapid fluorescent focus inhibition test (RFFIT).
Secondary Outcome Measure † Geometric Mean Antibody Concentrations (GMCs) at Year 3.
Condition † Rabies
Intervention † BiologicalPurified Chick-Embryo Cell Rabies Vaccine
Study Arms / Comparison Groups Booster dose single group Subjects who received a primary series of accelerated or conventional rabies PrEP IM regimen in the parent study, will receive a booster dose based on their individual antibody concentrations measured over time.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Biological
Estimated Enrollment † 578
Start Date † October 1, 2015
Completion Date December 3, 2022
Primary Completion Date December 3, 2022
Eligibility Criteria † Inclusion Criteria: - All individuals who were randomized to a Rabies primary series vaccination for pre-exposure prophylaxis (PrEP), received the full PrEP regimen and completed the parent trial following study protocol. Exclusion Criteria: - Completed the parent study without receiving the full 3 rabies vaccine doses following the assigned pre-exposure prophylaxis regimen. - History of exposure to suspected or confirmed rabid animal. - Receipt of rabies immunoglobulins, rabies post exposure prophylaxis following completion of the parent study
Gender All
Ages N/A - N/A
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † Austria
Administrative Information
NCT ID † NCT02545517
Organization ID 205214
Secondary IDs †† 2015-000382-31, v49_23E1
Responsible Party Sponsor
Study Sponsor † GlaxoSmithKline
Collaborators ††
Investigators † Study Director: GSK Clinical Trials, GlaxoSmithKline
Information Provided By
Verification Date March 2017
First Received Date † August 31, 2015
Last Updated Date March 31, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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