Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

Study Overview
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Brief Summary
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The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese people.

Official Title
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Phase IV Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine in Health Chinese Children and Adult

Conditions
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Hepatitis A

Intervention / Treatment
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* Biological: Attenuated Hepatitis A Vaccine, H2 Strain
* Biological: Inactivated Hepatitis A Vaccine, Lu8 Strain
* Biological: Group A Meningococcal Polysaccharide vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Only subjects fulfilling all of the following criteria will be eligible for the study: People aged from 18 months to 65 years old. The subjects or subjects' guardians are able to understand and sign the informed consent The subjects or subjects' guardians allow to comply with the requirements of the protocol Subjects with temperature <=37.0°C on axillary setting The subjects have signed informed consent already Exclusion Criteria: Subjects will not be eligible for the study if any of the following criteria is met: Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc. Have a history of neurological symptoms or signs Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc. Suffering from serious chronic diseases Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months Any prior diseases including human immunodeficiency virus infection or related Bleeding constitution or prolong bleeding time situation Accept hepatitis A vaccination within a month Received vaccines, other immune globulin, any research drug injections in the past 4 weeks People who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days Caught a fever with axillary temperature 38°C or higher in past 3 days Take part in another clinical researchers Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent Pregnancy test result is positive

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attenuated Hepatitis A Vaccine, H2 Strain<br>Health subjects received attenuated Hepatitis A vaccine intramuscularly in the deltoid region. | Biological: Attenuated Hepatitis A Vaccine, H2 Strain<br>* 6.50 lgCCID50/ml in babies aged 18-35 months\6.50 lgCCID50/ml in children aged 3-16 years \6.50 lgCCID50/ml in adults aged 17 up to 65 years old<br>|
| Experimental: Inactivated Hepatitis A Vaccine, Lu8 Strain<br>Health subjects received inactivated Hepatitis A vaccine intramuscularly in the deltoid region. | Biological: Inactivated Hepatitis A Vaccine, Lu8 Strain<br>* 320EU/Vial in babies aged 18-35 months \320EU/Vial in children aged 3-16 years \640EU/Vial in adults aged 17 up to 65 years old\boost at month 6\two-dose<br>|
| Placebo Comparator: Group A Meningococcal Polysaccharide vaccine<br>Health subjects received Group A Meningococcal Polysaccharide vaccine intramuscularly in the deltoid region. | Biological: Group A Meningococcal Polysaccharide vaccine<br>* 30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of hepatitis A antibody concentration | Changes of anti Hepatitis A antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination. | 37 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events | Compare incidence of all the solicited events(AEs), unsolicited AEs and serious AEs within 28 days post-vaccination. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Immunogenicity, Vaccine, Hepatitis A