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Completed

NCT Number: NCT00825305

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

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jizhou, Hebei, 053200, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Abbreviated Zagreb 2-1-1 schedule

Biological

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

Other names: PCEC Rabies vaccine for human use

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

Biological

Subjects received the standard Essen regimen.

Other names: PCEC Rabies vaccine for human use

Primary outcomes

  1. Rabies Virus Neutralizing Antibody Concentrations on Day 14.

    Time frame: 14 days

    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.

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

    Time frame: 7 days after each 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 outcomes

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

    Time frame: 7 days and 42 days

    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.

  2. Percentages of Participants With Seroconversion (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

    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.

Sponsors and collaborators

Lead sponsor

Novartis Vaccines

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jan 21, 2009
Registry last updated
Dec 13, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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