Comparative Immunogenicity Study of Two Hepatitis A Vaccines

NCT ID: NCT03231605

Last Updated: 2017-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-26

Study Completion Date

2017-12-29

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group 1

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

Group Type EXPERIMENTAL

Hepatitis A Vaccine

Intervention Type BIOLOGICAL

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

Group 2

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

Group Type ACTIVE_COMPARATOR

Hepatitis A Vaccine

Intervention Type BIOLOGICAL

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

Interventions

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Hepatitis A Vaccine

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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℃

* Have a serious chronic disease
* Any conditions which researcher think will influence the results or the subjects.

Exclusion Criteria

* Having severe diseases.
* Allergy to the components in Vaccine
* Immune abnormalities
Minimum Eligible Age

18 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shaanxi Provincial Center for Disease Control and Prevention

OTHER

Sponsor Role collaborator

China National Biotec Group Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanxi Provincial Center for Disease Control and Prevention

Yuncheng, Shanxi, China

Site Status

Countries

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China

Other Identifiers

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91110000100010062X

Identifier Type: -

Identifier Source: org_study_id

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