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

Primary Purpose

Rabies

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Abbreviated Zagreb 2-1-1 schedule
Standard Essen 1-1-1-1-1 schedule
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rabies focused on measuring vaccine, prevention, rabies, Rabies disease

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Zagreb (2-1-1)

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

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 19, 2009
Last Updated
December 7, 2011
Sponsor
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT00825305
Brief Title
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

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies
Keywords
vaccine, prevention, rabies, Rabies disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
825 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zagreb (2-1-1)
Arm Type
Experimental
Arm Description
Rabies PCEC vaccine was applied according Zagreb schedule with 2 vaccinations on day 0, 1 vaccination on day 7 and day 21, respectively
Arm Title
Essen (1-1-1-1-1)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Abbreviated Zagreb 2-1-1 schedule
Other Intervention Name(s)
PCEC Rabies vaccine for human use
Intervention Description
Subjects received the abbreviated Zagreb 2-1-1 schedule in a safety-lead-in phase.
Intervention Type
Biological
Intervention Name(s)
Standard Essen 1-1-1-1-1 schedule
Other Intervention Name(s)
PCEC Rabies vaccine for human use
Intervention Description
Subjects received the standard Essen regimen.
Primary Outcome Measure Information:
Title
Rabies Virus Neutralizing Antibody Concentrations on Day 14.
Description
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.
Time Frame
14 days
Title
Number of Participants Who Reported a Local or Systemic Reaction After Any Vaccination
Description
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.
Time Frame
7 days after each vaccination
Secondary Outcome Measure Information:
Title
Rabies Virus Neutralizing Antibody Concentrations on Day 7 and Day 42.
Description
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.
Time Frame
7 days and 42 days
Title
Percentages of Participants With Seroconversion (Rabies Virus Neutralizing Antibody Concentrations Equal and Above 0.5 IU/ml) on Days 7, 14 and 42.
Description
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.
Time Frame
7 days, 14 days and 42 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis Vaccines
Official's Role
Study Chair
Facility Information:
City
Jizhou City
State/Province
Hebei
ZIP/Postal Code
053200
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25483635
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. Erratum In: Hum Vaccin Immunother. 2015;11(5):1295. Claudius, Malerczyk [corrected to Malerczyk, Claudius].
Results Reference
derived

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

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