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Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects

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Disease Information

Descriptive Information
Brief Title † Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects
Official Title † A Phase III, Multicenter, Observer-blind, Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Concomitantly and/or Separately According to 1 of 2 Different Preexposure Prophylaxis Schedules to Healthy Adult Subjects.
Brief Summary Establish non-inferiority of the immune response and evaluate the safety and tolerability of Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to either of 2 schedules for preexposure prophylaxis.
Detailed Description
Study Phase Phase 3
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary Outcome Measure † Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination
Secondary Outcome Measure † RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination
Condition † Rabies Japanese Encephalitis
Intervention † BiologicalRabies
Study Arms / Comparison Groups R/JE - Conv Subjects received Rabies and Japanese Encephalitis (JE) vaccines following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm. R/JE - Acc Subjects received Rabies and JE vaccines following the accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm. R - Conv Subjects received Rabies vaccine following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm. JE - Conv Subjects received JE vaccine following the conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
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 † 661
Start Date † August 2012
Completion Date October 2013
Primary Completion Date December 2012
Eligibility Criteria † Inclusion Criteria: 1. Males and females between 18 and 65 years of age (inclusive). 2. Subjects who have given written consent. 3. Individuals in good health as per investigator judgement. Exclusion Criteria: 1. If female, pregnancy or unwillingness to practice acceptable contraception. 2. If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test. 3. Contraindication or precaution against Rabies and Japanese Encephalitis vaccination. 4. Unable to comprehend and to follow all required study procedures for the whole period of the study. 5. Participating in any other clinical trial 30 days prior to first study visit. 6. History of previous rabies/rabies immunoglobulin and/or Japanese Encephalitis immunization. 7. Receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day 43. 8. Received any other vaccines within 2 weeks prior to enrollment in this study or plan to receive any vaccine within 4 weeks from the study vaccines. 9. Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks. 10. Individuals who are part of study personnel or close family members conducting this study. 11. Body temperature ≥38 degrees Celsius (≥ 100.4° F) within 3 days of intended study vaccination. 12. Plans to travel within the next year to areas where Rabies and/or Japanese Encephalitis vaccine may be considered or offered. This includes but is not limited to India, Asia, Pacific-Rim, African countries.
Gender Both
Ages 18 Years - 65 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † Austria
Administrative Information
NCT ID † NCT01662440
Organization ID V49_23
Secondary IDs †† 2011-005173-23
Responsible Party Sponsor
Study Sponsor † Novartis Vaccines
Collaborators ††
Investigators † Study Chair: Novartis Vaccines and Diagnostics, Novartis Vaccines
Information Provided By
Verification Date December 2014
First Received Date † August 2, 2012
Last Updated Date December 2, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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