Evaluation of the Safety and Immunogenicity of Hepatitis A Vaccine

This is an interventional prevention trial for Vaccination Read More

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℃.

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 ℃ 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.