A Single-centre, Randomized, Double-blind, Parallel Control, Phase 3 Study to Evaluate the Safety and Immunogenicity of a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects Aged 10-60 Years

Jiangsu Province Centers for Disease Control and Prevention1 site in 1 country1,200 target enrollmentAugust 2012

ConditionsRabies

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Rabies
Sponsor: Jiangsu Province Centers for Disease Control and Prevention
Enrollment: 1200
Locations: 1
Primary Endpoint: Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1) vaccination.

Detailed Description

There will be two immunization arms. 1200 healthy subjects will be randomly assigned (1:1) to receive an experimental vaccine or a parallel comparator vaccine. All of them will be received five doses of rabies vaccine at day 0,3,7,14,28 according to the traditional Essen methods (1-1-1-1-1) vaccination.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

December 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jiangsu Province Centers for Disease Control and Prevention

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged from 10 to 60 years old
•Subjects or legal guardians can and will comply with the requirements of the protocol
•Subjects or legal guardians are able to understand and sign the informed consent
•Healthy subjects judged from medical history after investigator's inquiry
•Subjects with temperature \<=37.0°C on axillary setting

Exclusion Criteria

•Female in lactation or pregnancy, or plan to be pregnant during the study period
•Subject who has allergic history to any vaccine or other medicines
•Subject who has injury history by dogs or other mammals and has been vaccinated with rabies vaccine
•Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain
•Subject with congenital malformation, developmental disorder or serious chronic disease
•Subject with autoimmune diseases or immunodeficiency
•Subject with asthma, unstable over the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids
•Subject with diabetes (Type I or II) excluding gestational diabetes
•Subject with thyroidectomy history, or require treatment in the past 12 months due to thyroid disease
•Subject with severe angioedema in the past 3 years or require treatment in the past 2 years

Outcomes

Primary Outcomes

Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination

Time Frame: 42 days after full vaccination

Secondary Outcomes

Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 42 days after full vaccination(42 days after full vaccination)
Positive seroconversion rate of serum rabies virus neutralizing antibody 14 days after full vaccination(14 days after full vaccination)
Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 14 days after full vaccination(14 days after full vaccination)
Incidence of local and systemic adverse reactions during safety observation period after each vaccination(0-7 days after each vaccination and 8-28 days after the fifth vaccination)