Rabies Clinical Trial
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
Verified date | April 2014 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 644 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Mengshan Center for Disease Prevention and Control (CDC) | Mengshan | Guangxi |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 14 days after first vaccination (day 15) | No |
Primary | 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 the First Vaccination in Older Adults Aged =51 Years | Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 14 days after first vaccination (day 15). | No |
Primary | Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Days 1 to 7 postvaccination | Yes |
Primary | Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur | Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Days 1 to 7 postvaccination | Yes |
Primary | Number of Children Who Reported Unsolicited Adverse Events (AEs) | The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43. | From V1/day 1 (postvaccination) through V7/study termination day 43 | Yes |
Primary | Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) | The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43. | from V1/day 1 (postvaccination) through V7/study termination day 43 | Yes |
Secondary | Percentages of Children With RVNA Titers =0.5 IU/mL 14 Days After First Vaccination of Rabipur | Immunogenicity was measured as the percentages of subjects who achieved RVNA titers =0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 14 days after first vaccination (day 15). | No |
Secondary | Percentages of Older Adults With RVNA Titers =0.5 IU/mL 14 Days After First Vaccination of Rabipur | Immunogenicity was measured as the percentages of subjects who achieved RVNA titers =0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 14 days after first vaccination (day 15). | No |
Secondary | Percentages of Children With RVNA Titers =0.5 IU/mL 42 Days After First Vaccination of Rabipur | Immunogenicity was measured as the percentages of subjects who achieved RVNA titers =0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 42 days after first vaccination (day 43). | No |
Secondary | Percentages of Older Adults With RVNA Titers =0.5 IU/mL 42 Days After First Vaccination of Rabipur | Immunogenicity was measured as the percentages of subjects who achieved RVNA titers =0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 42 days after first vaccination (day 43). | No |
Secondary | GMCs of RVNA Titer 42 Days After First Vaccination in Children. | Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 42 days after first vaccination (day 43) | No |
Secondary | GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. | Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule. | Before vaccination (day 1) and 42 days after first vaccination (day 43) | No |
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