Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2014

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Attenuated Hepatitis A Vaccine, H2 Strain
    • Health subjects received attenuated Hepatitis A vaccine intramuscularly in the deltoid region.
  • Experimental: Inactivated Hepatitis A Vaccine, Lu8 Strain
    • Health subjects received inactivated Hepatitis A vaccine intramuscularly in the deltoid region.
  • Placebo Comparator: Group A Meningococcal Polysaccharide vaccine
    • Health subjects received Group A Meningococcal Polysaccharide vaccine intramuscularly in the deltoid region.

Clinical Trial Outcome Measures

Primary Measures

  • Changes of hepatitis A antibody concentration
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Months

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Jiangsu Province Centers for Disease Control and Prevention
  • Collaborator
    • Institute of Medical Biology, Chinese Academy of Medical Sciences
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jingsi Yang, PhD, Study Chair, Institude of Medical Biology, Chinese Academy of Medical Sciences
    • Fubao Ma, Study Director, Jiangsu Provincial Center for Disease Control and Prevention
    • Qiangming Sun, PhD, Principal Investigator, Institude of Medical Biology, Chinese Academy of Medical Sciences
    • Guodong Kang, Principal Investigator, Jiangsu Provincial Center for Disease Control and Prevention

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.