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

Rabies Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00825305
• Other study ID #: M49P8
• Status: Completed
• Phase: Phase 3
• First received: January 19, 2009
• Last updated: December 7, 2011
• Start date: November 2008
• Est. completion date: January 2009

Study information

• Verified date: December 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 825
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rabies

Intervention

Biological:
• Abbreviated Zagreb 2-1-1 schedule
Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase.
• Standard Essen 1-1-1-1-1 schedule
Subjects received the standard Essen regimen.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.	Rabies virus neutralizing antibody concentrations 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.	7 days and 42 days	No
Secondary	Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.	Percentages of participants with seroconversion (defined as 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	No