Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-10-31

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.

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Detailed Description

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Conditions

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Hepatitis A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Attenuated Hepatitis A Vaccine, H2 Strain

Health subjects received attenuated Hepatitis A vaccine intramuscularly in the deltoid region.

Group Type EXPERIMENTAL

Attenuated Hepatitis A Vaccine, H2 Strain

Intervention Type BIOLOGICAL

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

Inactivated Hepatitis A Vaccine, Lu8 Strain

Health subjects received inactivated Hepatitis A vaccine intramuscularly in the deltoid region.

Group Type EXPERIMENTAL

Inactivated Hepatitis A Vaccine, Lu8 Strain

Intervention Type BIOLOGICAL

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

Group A Meningococcal Polysaccharide vaccine

Health subjects received Group A Meningococcal Polysaccharide vaccine intramuscularly in the deltoid region.

Group Type PLACEBO_COMPARATOR

Group A Meningococcal Polysaccharide vaccine

Intervention Type BIOLOGICAL

30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old

Interventions

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Attenuated Hepatitis A Vaccine, H2 Strain

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

Intervention Type BIOLOGICAL

Inactivated Hepatitis A Vaccine, Lu8 Strain

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

Intervention Type BIOLOGICAL

Group A Meningococcal Polysaccharide vaccine

30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old

Intervention Type BIOLOGICAL

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

Minimum Eligible Age

18 Months

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes