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

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase

Completed

Phase 3

Conditions

Rabies

Treatments

Biological: Changchun Werersai

Biological: Jilin Maifeng

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT02491541

20120002

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,200 patients

Sex

All

Ages

10 to 60 years old

Volunteers

Accepts Healthy Volunteers

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