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Comparative Immunogenicity Study of Two Hepatitis A Vaccines

Primary Purpose

Hepatitis A

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Hepatitis A Vaccine
Sponsored by
China National Biotec Group Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatitis A

Eligibility Criteria

18 Months - 24 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shanxi Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine.
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
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.

Full Information

First Posted
July 20, 2017
Last Updated
July 30, 2017
Sponsor
China National Biotec Group Company Limited
Collaborators
Shaanxi Provincial Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03231605
Brief Title
Comparative Immunogenicity Study of Two Hepatitis A Vaccines
Official Title
Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 26, 2017 (Actual)
Primary Completion Date
August 31, 2017 (Anticipated)
Study Completion Date
December 29, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
China National Biotec Group Company Limited
Collaborators
Shaanxi Provincial Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis A

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited
Intervention Type
Biological
Intervention Name(s)
Hepatitis A Vaccine
Intervention Description
Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .
Primary Outcome Measure Information:
Title
To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine.
Description
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.
Time Frame
35-42 days
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
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.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Shanxi Provincial Center for Disease Control and Prevention
City
Yuncheng
State/Province
Shanxi
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Based on the literature public progress.
Links:
URL
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003939.pdf
Description
The reference 5
URL
https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM164319.pdf
Description
The reference 6
URL
http://med.wanfangdata.com.cn/Paper/Detail?id=PeriodicalPaper_zgswzpxzz200909021
Description
The reference 8
URL
http://www.wenkuxiazai.com/doc/c36ab52c58fb770bf78a5529.html
Description
The reference 9

Learn more about this trial

Comparative Immunogenicity Study of Two Hepatitis A Vaccines

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