A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults

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Disease Information

Descriptive Information
Brief Title † A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults
Official Title † A Phase IIIb, Randomized, Open-label Study Comparing Two Different Rabies Vaccine Post-exposure Schedules (Zagreb 2-1-1 and Rabipur® Essen 1-1-1-1-1) in Chinese Children and Older Adults
Brief Summary This study was designed to evaluate the safety and immunogenicity of two simulated postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese children and older adults.
Detailed Description This study was designed to evaluate the safety and immunogenicity of Rabipur Zagreb (2-1-1) and Rabipur Essen (1-1-1-1-1) simulated post exposure vaccination schedules in Chinese children and older adults. Subjects randomized to Group 1 (Zagreb) will receive 4 doses of rabies vaccine Day 1 (2 doses), and on Day 8 and Day 22. Subjects randomized to Group 2 (Essen) will receive 5 doses of rabies vaccine on Days 1, 4, 8, 15, and 29. First vaccine will be administered on study Day 1. 240 children and 400 older adults, a total of 640, is planned to be enrolled into the study. Subjects will be divided further into age subsets of equal numbers within each age cohort (children: 6 to 11 years of age and 12 to 17 years of age; older adults: 51 to 60 years of age and 61 years of age and older. Within each age subset, subjects will be assigned randomly in a 1:1 ratio. The primary objective is to establish the non-inferiority of the Rabipur Zagreb (2-1-1) schedule relative to the conventional Rabipur Essen (1-1-1-1-1) schedule based on geometric mean titers (GMC), and the secondary objective is to assess the percent of subjects with rabies virus neutralizing titer ≥ 0.5 IU/mL 14 days after the first vaccinations (study Day 15) for each schedule and age cohort
Study Phase Phase 3
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary Outcome Measure † Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.
Secondary Outcome Measure † Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
Condition † Rabies
Intervention † BiologicalZagreb
Study Arms / Comparison Groups Zagreb(≥6 to ≤17 Years) Zagreb(≥51 Years) Essen(≥6 to ≤17 Years) Essen(≥51 Years)
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 † 644
Start Date † September 2012
Completion Date January 2013
Primary Completion Date January 2013
Eligibility Criteria † Inclusion Criteria: - Individuals between 6-17 years of age and 51 years of age or older - Individuals who were in good health - Provided consent, complied with study procedures and duration of follow-up Exclusion Criteria: - Contraindications to vaccination with rabies vaccine - Body temperature ≥37.5◦C (axillary) within 3 days of intended study vaccination - Known hypersensitivity to the components of the vaccine - Previously received any rabies vaccine or immune globulin - Previous or planned treatment with antimalarial medications - History of psychiatric disease, immune disorder, bleeding disorder, drug/alcohol abuse within the past 2 years, malignancy - Female subjects who were pregnant or unwilling to practice acceptable birth control methods - Individuals enrolled or plans to enroll in another investigational trial
Gender Both
Ages 6 Years - N/A
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † China
Administrative Information
NCT ID † NCT01680016
Organization ID V49_24
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Novartis Vaccines
Collaborators ††
Investigators † Study Chair: Novartis Vaccines, Novartis Vaccines
Information Provided By
Verification Date April 2014
First Received Date † September 3, 2012
Last Updated Date April 22, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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