The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

Study Overview
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Brief Summary
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The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.

Detailed Description
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Hepatitis A refers to liver inflammation caused by infection with the hepatitis A virus. HAV is is one of the most common hepatitis viruses that can cause hepatitis in China. The data from the phase 1, 2 and 3 trials suggested that both inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese people.

Official Title
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Phase 4 Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine

Conditions
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Hepatitis A

Intervention / Treatment
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* Biological: Attenuated HAV Vaccine, H2 Strain
* Biological: Attenuated HAV Vaccine, L-A-1 Strain
* Biological: Inactivated HAV Vaccine, Lu8 Strain
* Biological: Inactivated HAV Vaccine, TZ84 Strain


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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Attenuated HAV Vaccine, H2 Strain<br>6.50 lgCCID50/ml in babies aged 18-35 months\6.50 lgCCID50/ml in children aged 3-15 years \6.50 lgCCID50/ml in adults aged 16 up to 65 years old | Biological: Attenuated HAV Vaccine, H2 Strain<br>* 6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).<br>* Other names: Hepatitis A (Live) Vaccine, Freeze-dried;|
| Experimental: Attenuated HAV Vaccine, L-A-1 Strain<br>6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose). | Biological: Attenuated HAV Vaccine, L-A-1 Strain<br>* 6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).<br>* Other names: Hepatitis A Vaccine;|
| Experimental: Inactivated HAV Vaccine, Lu8 Strain<br>320EU/Vial in babies aged 18-35 months\320EU/Vial in children aged 3-15 years \640EU/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose | Biological: Inactivated HAV Vaccine, Lu8 Strain<br>* 320EU/Vial in babies aged 18-35 months\320EU/Vial in children aged 3-15 years \640EU/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose<br>* Other names: Hepatitis A Vaccine, Inactivated;|
| Experimental: Inactivated HAV Vaccine, TZ84 Strain<br>250U/Vial in babies aged 18-35 months\250U/Vial in children aged 3-15 years \500U/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose | Biological: Inactivated HAV Vaccine, TZ84 Strain<br>* 250U/Vial in babies aged 18-35 months\250U/Vial in children aged 3-15 years \500U/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose.<br>* Other names: Hepatitis A Vaccine, Inactivated;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes of hepatitis A antibody concentration | 1. Changes of anti-HAV antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination. | up to 43 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of all the adverse events in vaccine group and placebo group | compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine group and placebo group. | up to 43 months | 

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