Phase 3
N=825
Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)
Rabies
Bottom Line
View on ClinicalTrials.gov: NCT00825305 ↗Enrolled (actual)
825
Serious AEs
0.1%
Results posted
May 2010
Primary outcome: Primary: Rabies Virus Neutralizing Antibody Concentrations on Day 14. — 3.1; 3.3 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Abbreviated Zagreb 2-1-1 schedule (Biological); Standard Essen 1-1-1-1-1 schedule (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rabies Virus Neutralizing Antibody Concentrations on Day 14. |
3.1; 3.3 | — |
| PRIMARY Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination |
483; 241; 37; 18; 42; 38 | — |
| SECONDARY Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42. |
-3.23; -3.02; 4.25; 4.32 | — |
| SECONDARY Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42. |
10.14; 10.0; 100; 97.14; 100; 100 | — |
Summary
This study investigates the safety and immunogenicity (non-inferiority) of a Purified Chick Embryo Cell Vaccine (PCECV) administered in two different schedules (conventional versus abbreviated schedule) in healthy adults 18 to 50 years of age in China
Eligibility Criteria
Inclusion Criteria
- Male and female subjects 18-50 years of age who:
- are in good health at the time of entry into the study as determined by medical history, physical examination and clinical judgment of the investigator;
- volunteer for the simulated post-exposure vaccination courses and blood draws;
- have given a written informed consent; informed consent must be obtained for all the subjects before enrolment in the study;
- are available for all the visits scheduled in the study.
Exclusion Criteria
- Subjects with the below criteria were excluded:
- pregnancy or unwillingness to practice acceptable contraception during participation in the study;
- a history of rabies immunization;
- a significant acute or chronic infectious disease that may impact the subject's safety and /or immunogenicity in the Investigators opinion at the time of enrolment;
- fever ≥ 38.0°C (axillary) or/and significant acute or chronic infection requiring systemic antibiotic or antiviral therapy within the past 7 days before enrolment;
- treatment with corticosteroids, immunosuppressive or antimalaria drugs during the two month period before enrolment;
- administration of any vaccine within the past 14 days before enrolment;
- known/suspected immunodeficiency, or autoimmune disease, or any immunologic disorder;
- history of allergy to egg protein;
- known hypersensitivity to neomycin, tetracycline, amphotericin-B, or any other vaccine component;
- treatment with parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months;
- mental condition rendering the subject unable to understand the nature, scope and consequences of the study;
- participation in any other investigational trial within the past 3 months before enrolment;
- planned surgery during the study period;
- intention to leave the area of the study site before the end of study period;
- any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objective.
Data sourced from ClinicalTrials.gov (NCT00825305). 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.