A Phase 3 Clinical Trial for a Rabies Vaccine (Vero Cell) for Human Use in Healthy Chinese Subjects

NCT ID: NCT02491541

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-12-31

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.

Conditions

Rabies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Changchun Werersai

A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd.

Group Type: EXPERIMENTAL

Changchun Werersai

Intervention Type: BIOLOGICAL

A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd.

1.0 ml experimental vaccine on day 0,3,7,14,28

Jilin Maifeng

A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd.

Group Type: ACTIVE_COMPARATOR

Jilin Maifeng

Intervention Type: BIOLOGICAL

A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd.

1.0 ml comparator vaccine on day 0,3,7,14,28

Interventions

Changchun Werersai

A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd.

1.0 ml experimental vaccine on day 0,3,7,14,28

Intervention Type: BIOLOGICAL

Jilin Maifeng

A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd.

1.0 ml comparator vaccine on day 0,3,7,14,28

Intervention Type: BIOLOGICAL

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
• Subject with hypertension and with a blood pressure exceeding 145/95 mmHg at enrollment time
• Subject with coagulation abnormalities diagnosed by doctors (such as clotting factor deficiency, coagulation disorders, platelet disorder) or obvious bruises or blood clotting disorder
• Subject with cancer, or has been treated in active cancer period or not clearly cured, or may recur during the study period
• Subject with epilepsy, excluding those alcohol epilepsy within three years before quitting drinking or those do not need treatment in the past 3 years
• Asplenia, functional asplenia, without a spleen or removal of the spleen caused by any situation
• Guillain-Barre syndrome
• Any prior administration of immunodepressant or corticosteroids in last 6 months
• Any prior administration of blood products in last 3 months
• Any prior administration of other research medicine/vaccine in last 30 days
• Any prior administration of any attenuated live vaccine in last 30 days
• Any prior administration of subunit or inactivated vaccines in last 14 days, such as pneumococcal vaccine
• Ongoing anti-tuberculosis prevention or treatment
• Subject who cannot comply with the trial requirements, or with mental illness/ dual-stage affective psychosis in the past or at present; or has not been controlled and needs to take psychiatric drugs the past 2 years; or with suicidal tendencies in the past 5 years
• Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuemei Hu

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Diseases Control and Prevention

Locations

Xinyi Center for Disease Control and Prevention

Xuzhou, Jiangsu, China

Countries

China

Other Identifiers

20120002

Identifier Type: -

Identifier Source: org_study_id