Status:
COMPLETED
Immunity Duration of Rabies Vaccine and Booster Dose Effects at 10 Years Post-primary Vaccination
Lead Sponsor:
Jiangsu Province Centers for Disease Control and Prevention
Conditions:
Rabies
Eligibility:
All Genders
20-70 years
Phase:
NA
Brief Summary
A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd is used to prevent human rabies. The vaccine was completed in the Phase III cl...
Eligibility Criteria
Inclusion
- Participants who participated in the Phase III clinical study of the vaccine and completed the full immunization
- Subjects or legal guardians can and will comply with the requirements of the protocol
- Subjects are able to understand and sign the informed consent
- Subjects with temperature \<=37.0°C on axillary setting
Exclusion
- Female in pregnancy
- Subjects who have been vaccinated other rabies vaccines after participating in the phase III clinical study of the vaccine (excluding those who participated in the 8-year booster immunization)
- Subject who has serious adverse reaction history after vaccination such as allergies, hives, difficulty in breathing, angioedema or abdominal pain or allergic to any ingredient of the this rabies vaccine, including excipient
- Any acute disease, serious chronic disease, fever，and chronic disease at acute stage
- 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 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 uncontrolled epilepsy or other progressive neurological disease
- Asplenia, functional asplenia, without a spleen or removal of the spleen caused by any situation
- Any prior administration of immunodepressant, cytotoxic treatment or inhaled corticosteroids in last 6 months, excluding those corticosteroid spray therapy for allergic rhinitis, topical corticosteroid treatment for acute non-concurrent dermatitis)
- 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
- Any medical, psychological, social or other condition judged by investigator, that may interfere subject's compliance with the protocol or signature on informed consent
- Untolerable adverse reactions occurred after booster dose injection within 10 years later;
- Any condition that in the opinion of the investigators may be not suitable for continued participation after booster dose injection within 10 years later
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 19 2019
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT03774628
Start Date
August 1 2018
End Date
February 19 2019
Last Update
December 1 2020
Active Locations (1)
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1
Lianshui Xinyi Center for Disease Control and Prevention
Huai'an, Jiangsu, China, 223400