Safety and Immunogenicity (Non-inferiority) of a Purified Chick Embryo Cell Vaccine Vaccine Administered in Two Different Schedules (Conventional Versus Abbreviated Schedule)

NCT ID: NCT00825305

Last Updated: 2011-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 825 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-01-31

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

Conditions

Rabies

Keywords

vaccine; prevention; rabies; Rabies disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Zagreb (2-1-1)

Rabies PCEC vaccine was applied according Zagreb schedule with 2 vaccinations on day 0, 1 vaccination on day 7 and day 21, respectively

Group Type: EXPERIMENTAL

Abbreviated Zagreb 2-1-1 schedule

Intervention Type: BIOLOGICAL

Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase.

Essen (1-1-1-1-1)

Rabies PCEC vaccine was applied according Essen schedule, i.e. 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.

Group Type: ACTIVE_COMPARATOR

Standard Essen 1-1-1-1-1 schedule

Intervention Type: BIOLOGICAL

Subjects received the standard Essen regimen.

Interventions

Abbreviated Zagreb 2-1-1 schedule

Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase.

Intervention Type: BIOLOGICAL

Standard Essen 1-1-1-1-1 schedule

Subjects received the standard Essen regimen.

Intervention Type: BIOLOGICAL

Other Intervention Names

PCEC Rabies vaccine for human use; PCEC Rabies vaccine for human use

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines

Role: STUDY_CHAIR

Novartis Vaccines

Locations

Jizhou, Hebei, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 25483635 (View on PubMed)

Other Identifiers

M49P8

Identifier Type: -

Identifier Source: org_study_id