Clinical trial NCT00825305: Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)
Official title: A Phase III, Single Center, Randomized, Open-label Study, Comparing PCECV Administered in the Abbreviated Zagreb Regimen (2-1-1) to the Conventional Essen Regimen (1-1-1-1-1) in Healthy Volunteers in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rabies
Keywords: vaccine
prevention
rabies
Rabies disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-01-21
Enrollment: 825
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Primary outcomes:
measure: Rabies Virus Neutralizing Antibody Concentrations on Day 14.
timeFrame: 14 days
measure: Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination
timeFrame: 7 days after each vaccination
Secondary outcomes:
measure: Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.
timeFrame: 7 days and 42 days
measure: Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.
timeFrame: 7 days, 14 days and 42 days
Other outcomes:
Locations:
city: Jizhou City
country: China
state: Hebei
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: Ma J, Wang H, Li J, Chang L, Xie Y, Liu Z, Zhao Y, Malerczyk C. A randomized open-labeled study to demonstrate the non-inferiority of purified chick-embryo cell rabies vaccine administered in the Zagreb regimen (2-1-1) compared with the Essen regimen in Chinese adults. Hum Vaccin Immunother. 2014;10(10):2805-12. doi: 10.4161/21645515.2014.972773.