Comparative Immunogenicity Study of Two Hepatitis A Vaccines

Hepatitis A Clinical Trial

Official title:

Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03231605
• Other study ID #: 91110000100010062X
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: July 20, 2017
• Last updated: July 30, 2017
• Start date: July 26, 2017
• Est. completion date: December 29, 2017

Study information

• Verified date: July 2017
• Source: China National Biotec Group Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: December 29, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Months to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

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

Locations

Country	Name	City	State
China	Shanxi Provincial Center for Disease Control and Prevention	Yuncheng	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Shanxi Provincial Center for Disease Control and Prevention (China)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	35-42 days
Secondary	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.	1 month

External Links

•   The reference 1-4
•   The reference 5
•   The reference 6
•   The reference 7
•   The reference 8
•   The reference 9