Comparative Immunogenicity Study of Two Hepatitis A Vaccines

Sponsor

China National Biotec Group Company Limited (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03231605

Collaborator

Shaanxi Provincial Center for Disease Control and Prevention (Other)

300

Enrollment

Location

Arms

5.1

Anticipated Duration (Months)

58.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The susceptible population is Children and adolescence, also the morbidity in adult presented rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important role in National Immunisation Program(China). The aim of this experiment is to verify the effects of experimental group non-inferior than control group. The experiment methods is compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two Hepatitis A Vaccines in 18-24 months Chinese Children.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis A	Biological: Hepatitis A Vaccine	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines

Actual Study Start Date :

Jul 26, 2017

Anticipated Primary Completion Date :

Aug 31, 2017

Anticipated Study Completion Date :

Dec 29, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd	Biological: Hepatitis A Vaccine Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .
Active Comparator: Group 2 Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited	Biological: Hepatitis A Vaccine Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .

Arm

Intervention/Treatment

Experimental: Group 1

Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd

Biological: Hepatitis A Vaccine

Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .

Active Comparator: Group 2

Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited

Biological: Hepatitis A Vaccine

Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .

Outcome Measures

Primary Outcome Measures

To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine. [35-42 days]
Collecting serum of subjects before, after vaccination immediately and after 35-42 days, and testing the quantity of antibody. Compared the difference of antibody quantity between two types Hepatitis A Vaccine and the Multiple of antibody based on the time.

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [1 month]
Observation 30 minutes after vaccination and give guardians feedback forms to record untoward effects, collecting the forms after 1 month when the subjects conduct the third time blood collection.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Months to 24 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The healthy children in mental and physical aged between 18-24 months, and the guardians agree and fully understand the protocol.
No Hepatitis A disease and contraindication of vaccination
No history of Hepatitis A Vaccine
The subjects can follow the requirements of experiment project.
Do not vaccinate other vaccine in one months.
Axillary's temperature≤37℃

Exclusion Criteria:

Having severe diseases.
Allergy to the components in Vaccine
Immune abnormalities
The people who do not agree with the Inclusion Criteria
Have a serious chronic disease
Any conditions which researcher think will influence the results or the subjects.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanxi Provincial Center for Disease Control and Prevention	Yuncheng	Shanxi	China

Sponsors and Collaborators

China National Biotec Group Company Limited
Shaanxi Provincial Center for Disease Control and Prevention

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

China National Biotec Group Company Limited

ClinicalTrials.gov Identifier:

NCT03231605

Other Study ID Numbers:

91110000100010062X

First Posted:

Jul 27, 2017

Last Update Posted:

Aug 1, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hepatitis A

Hepatitis

Study Results

No Results Posted as of Aug 1, 2017