Phase 3
N=644
A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults
Rabies
Bottom Line
View on ClinicalTrials.gov: NCT01680016 ↗Enrolled (actual)
644
Serious AEs
0.2%
Results posted
May 2014
Primary outcome: 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. — 0.052; 0.054; 12; 14 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Zagreb (Biological); Essen (Biological)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
0.052; 0.054; 12; 14 | — |
| 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 |
0.057; 0.06; 8.57; 7.89 | — |
| PRIMARY Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur |
2; 1; 0; 0; 2; 1 | — |
| PRIMARY Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur |
1; 1; 0; 2; 1; 3 | — |
| PRIMARY Number of Children Who Reported Unsolicited Adverse Events (AEs) |
26; 28; 9; 6; 0; 0 | — |
| PRIMARY Number of Older Adults Who Reported Unsolicited Adverse Events (AEs) |
36; 39; 5; 15; 1; 0 | — |
| SECONDARY Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur |
0; 2; 0; 4; 0; 3 | — |
| SECONDARY Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur |
5; 4; 1; 4; 3; 4 | — |
| SECONDARY Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur |
0; 2; 0; 4; 0; 3 | — |
| SECONDARY Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur |
5; 4; 1; 4; 3; 4 | — |
| SECONDARY GMCs of RVNA Titer 42 Days After First Vaccination in Children. |
0.054; 0.053; 0.05; 0.055; 0.052; 0.054 | — |
| SECONDARY GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults. |
0.063; 0.06; 0.052; 0.06; 0.057; 0.06 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01680016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.