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Comparative Immunogenicity Study of Two Hepatitis A Vaccines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03231605
Recruitment Status : Unknown
Verified July 2017 by China National Biotec Group Company Limited.
Recruitment status was:  Enrolling by invitation
First Posted : July 27, 2017
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Shanxi Provincial Center for Disease Control and Prevention (China)
Information provided by (Responsible Party):
China National Biotec Group Company Limited

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 26, 2017
Estimated Primary Completion Date : August 31, 2017
Estimated Study Completion Date : December 29, 2017

Resource links provided by the National Library of Medicine


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 .




Primary Outcome Measures :
  1. To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine. [ Time Frame: 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 :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231605


Locations
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China, Shanxi
Shanxi Provincial Center for Disease Control and Prevention
Yuncheng, Shanxi, China
Sponsors and Collaborators
China National Biotec Group Company Limited
Shanxi Provincial Center for Disease Control and Prevention (China)

Additional Information:
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Responsible Party: China National Biotec Group Company Limited
ClinicalTrials.gov Identifier: NCT03231605    
Other Study ID Numbers: 91110000100010062X
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Based on the literature public progress.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs