Phase 3
N=661
Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects
Rabies · Japanese Encephalitis
Bottom Line
View on ClinicalTrials.gov: NCT01662440 ↗Enrolled (actual)
661
Serious AEs
1.5%
Results posted
Dec 2014
Primary outcome: Primary: Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination — 100; 100 Percentages of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rabies (Biological); Japanese Encephalitis (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination |
100; 100 | — |
| PRIMARY Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination |
99; 100 | — |
| SECONDARY RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination |
11; 9.9 | — |
| SECONDARY PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination |
291; 331 | — |
| SECONDARY Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination |
99; 100 | — |
| SECONDARY Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination |
99; 100 | — |
| SECONDARY Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL |
1; 1; 1; 4; 16; 4 | — |
| SECONDARY Kinetics of Rabies Immune Response Measured as the RVNA GMCs |
0.052; 0.053; 0.054; 0.071; 0.13; 0.076 | — |
| SECONDARY Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10 |
1; 6; 9; NA; 99; NA | — |
| SECONDARY Kinetics of JE Immune Response Measured as PRNT50 GMTs |
5.13; 5.63; 5.73; NA; 715; NA | — |
| SECONDARY Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination |
13; 31; 28; 3; 16; 11 | — |
| SECONDARY Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination |
20; 30; 6; 13; 19; 5 | — |
| SECONDARY Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection |
NA; NA; 20; 3; NA; NA | — |
| SECONDARY Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination |
39; 56; 46; 16; 35; 46 | — |
| SECONDARY Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57 |
69; 108; 110; 29; 2; 3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Males and females between 18 and 65 years of age (inclusive).
- Subjects who have given written consent.
- Individuals in good health as per investigator judgement.
Exclusion Criteria
- If female, pregnancy or unwillingness to practice acceptable contraception.
- If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test.
- Contraindication or precaution against Rabies and Japanese Encephalitis vaccination.
- Unable to comprehend and to follow all required study procedures for the whole period of the study.
- Participating in any other clinical trial 30 days prior to first study visit.
- History of previous rabies/rabies immunoglobulin and/or Japanese Encephalitis immunization.
- Receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days prior to Day 1 vaccination through Day 43.
- 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.
- Ever received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
- Individuals who are part of study personnel or close family members conducting this study.
- Body temperature ≥38 degrees Celsius (≥ 100.4° F) within 3 days of intended study vaccination.
- 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.
Data sourced from ClinicalTrials.gov (NCT01662440). 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.