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

NCT00825305 | Completed Phase 3 Results

• 1 other identifier: M49P8
• Study Type: interventional
• Target: 825
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Rabies Virus Neutralizing Antibody Concentrations on Day 14.

  Rabies virus neutralizing antibody concentrations of the abbreviated Zagreb regimen compared with the conventional Essen regimen. Results are presented on log2 scale. For results on original geometric (multiplicative) scale please raise numbers to the basis of 2.

  14 days

• Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination

  Specified local and systemic reactions were solicited for 7 days after each vaccination. Number of participants were calculated who reported a local or systemic reaction after any of the vaccinations.

  7 days after each vaccination

Secondary Outcomes (2)

• Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.

  7 days and 42 days

• Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.

  7 days, 14 days and 42 days

Study Arms (2)

Zagreb (2-1-1)

EXPERIMENTAL

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

Biological: Abbreviated Zagreb 2-1-1 schedule

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

ACTIVE COMPARATOR

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.

Biological: Standard Essen 1-1-1-1-1 schedule

Interventions

Abbreviated Zagreb 2-1-1 schedule BIOLOGICAL

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

Also known as: PCEC Rabies vaccine for human use

Zagreb (2-1-1)

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

Subjects received the standard Essen regimen.

Also known as: PCEC Rabies vaccine for human use

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (1)

Unknown Facility

Jizhou, Hebei, 053200, China

Location

Related Publications (1)

• 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.

  PMID: 25483635 DERIVED

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegContactVacUS.nvdit@Novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2009
• First Posted: January 21, 2009
• Study Start: November 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: December 13, 2011
• Results First Posted: May 19, 2010

Record last verified: 2011-12

Locations

CN (1)