Hepatitis A
Conditions
Keywords
Safety, Immunogenicity, Vaccine, Hepatitis A
Brief summary
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.
Interventions
BIOLOGICALAttenuated 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
BIOLOGICALInactivated 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
30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old
Sponsors
Institute of Medical Biology, Chinese Academy of Medical Sciences
Jiangsu Province Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Months to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of hepatitis A antibody concentration | 37 months | Changes of anti Hepatitis A antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 28 days | Compare incidence of all the solicited events(AEs), unsolicited AEs and serious AEs within 28 days post-vaccination. |
Countries
China
Outcome results
None listed