Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

Hepatitis A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601040
• Other study ID #: JSEPI-004
• Status: Completed
• Phase: Phase 4
• First received: October 25, 2015
• Last updated: November 6, 2015
• Start date: November 2011
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Jiangsu Province Center for Disease Control and Prevention
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13500
• Est. completion date: October 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

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

Locations

Country	Name	City	State
China	Institute of Medical Biology -Chinese Academy of Medical Sciences	Kunming	Yunnan
China	Jiangsu Provincial Center for Disease Control and Prevention	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention	Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Incidence of adverse events	Compare incidence of all the solicited events(AEs), unsolicited AEs and serious AEs within 28 days post-vaccination.	28 days	Yes