Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

Sponsor

Jiangsu Province Centers for Disease Control and Prevention (Other)

Overall Status

Completed

CT.gov ID

NCT02601040

Collaborator

Chinese Academy of Medical Sciences (Other)

13,500

Enrollment

Locations

Arms

Duration (Months)

6750

Patients Per Site

143.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis A	Biological: Attenuated Hepatitis A Vaccine, H2 Strain Biological: Inactivated Hepatitis A Vaccine, Lu8 Strain Biological: Group A Meningococcal Polysaccharide vaccine	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

13500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Attenuated Hepatitis A Vaccine, H2 Strain Health subjects received attenuated Hepatitis A vaccine intramuscularly in the deltoid region.	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
Experimental: Inactivated Hepatitis A Vaccine, Lu8 Strain Health subjects received inactivated Hepatitis A vaccine intramuscularly in the deltoid region.	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
Placebo Comparator: Group A Meningococcal Polysaccharide vaccine Health subjects received Group A Meningococcal Polysaccharide vaccine intramuscularly in the deltoid region.	Biological: Group A Meningococcal Polysaccharide vaccine 30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old

Arm

Intervention/Treatment

Experimental: Attenuated Hepatitis A Vaccine, H2 Strain

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

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

Experimental: Inactivated Hepatitis A Vaccine, Lu8 Strain

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

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

Placebo Comparator: Group A Meningococcal Polysaccharide vaccine

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

Biological: Group A Meningococcal Polysaccharide vaccine

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Incidence of adverse events [28 days]
Compare incidence of all the solicited events(AEs), unsolicited AEs and serious AEs within 28 days post-vaccination.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiangsu Provincial Center for Disease Control and Prevention	Nanjing	Jiangsu	China	210009
2	Institute of Medical Biology -Chinese Academy of Medical Sciences	Kunming	Yunnan	China	650118

Sponsors and Collaborators

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

Investigators

Study Chair: Jingsi Yang, PhD, Institude of Medical Biology, Chinese Academy of Medical Sciences
Study Director: Fubao Ma, Jiangsu Provincial Center for Disease Control and Prevention
Principal Investigator: Qiangming Sun, PhD, Institude of Medical Biology, Chinese Academy of Medical Sciences
Principal Investigator: Guodong Kang, Jiangsu Provincial Center for Disease Control and Prevention