Comparative Immunogenicity Study of Two Hepatitis A Vaccines

NCT03231605 | Unknown Phase 4

• 1 other identifier: 91110000100010062X
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis A

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  1 month

Study Arms (2)

Group 1

EXPERIMENTAL

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

Biological: Hepatitis A Vaccine

Group 2

ACTIVE COMPARATOR

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

Biological: Hepatitis A Vaccine

Interventions

Hepatitis A Vaccine BIOLOGICAL

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

Group 1; Group 2

Eligibility Criteria

• Age: 18 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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℃

You may not qualify if:

• Having severe diseases.
• Allergy to the components in Vaccine
• Immune abnormalities
• Have a serious chronic disease
• Any conditions which researcher think will influence the results or the subjects.

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Shaanxi Provincial Center for Disease Control and Prevention: collaborator

Study Sites (1)

Shanxi Provincial Center for Disease Control and Prevention

Yuncheng, Shanxi, China

Location

Related Links

• The reference 6
• The reference 8
• The reference 9

MeSH Terms

Conditions

Hepatitis A

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Hepatitis, Viral, Human; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2017
• First Posted: July 27, 2017
• Study Start: July 26, 2017
• Primary Completion: August 31, 2017
• Study Completion: December 29, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

CN (1)