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

NCT02491541 | Completed Phase 3

• 1 other identifier: 20120002
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Rabies

Outcome Measures

Primary Outcomes (1)

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

  42 days after full vaccination

Secondary Outcomes (4)

• 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

Study Arms (2)

Changchun Werersai

EXPERIMENTAL

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

Biological: Changchun Werersai

Jilin Maifeng

ACTIVE COMPARATOR

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

Biological: Jilin Maifeng

Interventions

Changchun Werersai 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

Changchun Werersai

Jilin Maifeng 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

Jilin Maifeng

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Province Centers for Disease Control and Prevention: lead

Study Sites (1)

Xinyi Center for Disease Control and Prevention

Xuzhou, Jiangsu, 221400, China

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Yuemei Hu

  Jiangsu Provincial Center for Diseases Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2015
• First Posted: July 8, 2015
• Study Start: August 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2013
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

CN (1)