Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects
NCT ID: NCT01662440
Last Updated: 2014-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
661 participants
INTERVENTIONAL
2012-08-31
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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.
Rabies
Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
Japanese Encephalitis
Subjects received two doses of Japanese Encephalitis vaccine.
Placebo
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
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.
Rabies
Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
Japanese Encephalitis
Subjects received two doses of Japanese Encephalitis vaccine.
Placebo
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
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.
Rabies
Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
Placebo
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
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.
Japanese Encephalitis
Subjects received two doses of Japanese Encephalitis vaccine.
Placebo
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
Interventions
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Rabies
Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
Japanese Encephalitis
Subjects received two doses of Japanese Encephalitis vaccine.
Placebo
Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
Eligibility Criteria
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Inclusion Criteria
2. Subjects who have given written consent.
3. Individuals in good health as per investigator judgement.
Exclusion Criteria
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.
18 Years
65 Years
ALL
Yes
Sponsors
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Novartis Vaccines
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Vaccines and Diagnostics
Role: STUDY_CHAIR
Novartis Vaccines
Locations
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Institute of Specific Prophylaxis and Tropical Medicine Center for Pathophysiology, Infectious Diseases and Immunology Medical University of Vienna
Kinderspitalgasse 15, Vienna, Austria
Bernhard Nocht Institute for Tropical Medicine
Bernhard-Nocht-Strasse 74, City state of Hamburg, Germany
The University of Zurich
Rämistrasse 71, Canton of Zurich, Switzerland
Countries
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References
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Cramer JP, Jelinek T, Paulke-Korinek M, Reisinger EC, Dieckmann S, Alberer M, Buhler S, Bosse D, Meyer S, Fragapane E, Costantini M, Pellegrini M, Lattanzi M, Dovali C. One-year immunogenicity kinetics and safety of a purified chick embryo cell rabies vaccine and an inactivated Vero cell-derived Japanese encephalitis vaccine administered concomitantly according to a new, 1-week, accelerated primary series. J Travel Med. 2016 Mar 19;23(3):taw011. doi: 10.1093/jtm/taw011. Print 2016 Mar.
Jelinek T, Cramer JP, Dieckmann S, Hatz C, Paulke-Korinek M, Alberer M, Reisinger EC, Costantini M, Gniel D, Bosse D, Lattanzi M. Evaluation of rabies immunogenicity and tolerability following a purified chick embryo cell rabies vaccine administered concomitantly with a Japanese encephalitis vaccine. Travel Med Infect Dis. 2015 May-Jun;13(3):241-50. doi: 10.1016/j.tmaid.2015.05.008. Epub 2015 May 18.
Other Identifiers
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2011-005173-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V49_23
Identifier Type: -
Identifier Source: org_study_id