Hepatitis A
Conditions
Interventions
Research Group1:One dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun Institute of Biological Products Co., Ltd., 0.5ml per dose.
Research Group2:One dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang Pukang Biotechnology Co., Ltd., 0.5ml per dose.
Research group 3:One dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Institute of Medical Biology, Chinese Academy of Medical Sciences. 1.0ml per dose.
Sponsors
Shaanxi Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects aged from 18 to 24 months old at the date of recruitment; 2) With informed consent signed by parent(s) or guardians; 3) Parent(s) or guardians are able to attend all planned clinical appointments and obey and follow all study instructions; 4) Subjects have not been vaccinated with any type of Hepatitis A vaccines; 5) Subjects have no Hepatitis A disease and contraindication of vaccination; 6) Subjects did not receive any vaccines within 14 days; 7) Before joining this trial, subjects must be qualified and passed their medical history and clinical examinations, and axillary's temperature must be <= 37 degrees.
Exclusion criteria
Exclusion criteria: 1) Subjects with history of allergy, convulsion, epilepsy, encephalopathy and psychosis or family history; 2) Allergic to any ingredient of vaccine or with allergy history to any vaccine; 3) Patients with immunodeficiency, in process of cancer treatment, immunosuppressive therapy (oral steroids) or HIV induced hypoimmunity, or in close contact with any family members who has congenital immune diseases; 4) Receive non-specific immunoglobulin within 1 month before recruitment; 5) Subjects with acute febrile diseases with body temperature > 37.0 degrees or infectious diseases; 6) Subjects with a history of thrombocytopenia or other coagulation disorders that may be contraindicated for hypodermic injection; 7) With known or suspected concurrent diseases include respiratory disease, acute infection or active chronic disease; 8) With severe cardiovascular diseases (Pulmonary heart disease, Pulmonary edema, hypertension cannot be controlled to normal range by drugs), liver and kidney diseases and diabetic complications; 9) Various infectious, suppurative or allergic dermatitis; 10) Other circumstances judged by investigators that are not suitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody Seroconversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Antibody Geometric Mean Titer (GMT);Adverse Drug Reaction (ADR) Incidence rate; | — |
Countries
China
Contacts
Public ContactJiang Wei
Changchun Institute of Biological Products Co., Ltd
Outcome results
None listed