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

Rabies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491541
• Other study ID #: 20120002
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2015
• Last updated: July 8, 2015
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2015
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rabies

Intervention

Biological:
• 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
• 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

Locations

Country	Name	City	State
China	Xinyi Center for Disease Control and Prevention	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination		42 days after full vaccination	No
Secondary	Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 42 days after full vaccination		42 days after full vaccination	No
Secondary	Positive seroconversion rate of serum rabies virus neutralizing antibody 14 days after full vaccination		14 days after full vaccination	No
Secondary	Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 14 days after full vaccination		14 days after full vaccination	No
Secondary	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	Yes