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Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines

Primary Purpose

Hepatitis A

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Healive+Healive

Healive+Havrix

Havrix+Havrix

Havrix+Healive

About this trial

This is an interventional prevention trial for Hepatitis A

Eligibility Criteria

18 Months - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy children aged between 1.5 and 5 years, with no history of hepatitis A virus infection or hepatitis A vaccine vaccination
Provided birth certification or vaccination card
Parent(s) or legal guardian(s) are able to understand and sign the informed consent

Exclusion Criteria:

Axillary temperature > 37.0 centigrade at the time of dosing
Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
Autoimmune disease or immunodeficiency
Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
History or family history of convulsions, epilepsy, brain disease and psychiatric
History of any blood products within 3 months
Administration of any other investigational research agents within 30 days
Administration of any live attenuated vaccine within 30 days
Administration of subunit or inactivated vaccines within 14 days
Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Sites / Locations

Tianjin Centers for Diseases Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Group 1: Healive+Healive

Group 2: Healive+Havrix

Group 3: Havrix+Havrix

Group 4: Havrix+Healive

Arm Description

75 subjects to receive two doses of Healive 6 months apart

75 subjects to receive one dose of Healive and another dose of Havrix 6 months apart

75 subjects to receive two doses of Havrix 6 months apart

75 subjects to receive one dose of Havrix and another dose of Healive 6 months apart

Outcomes

Primary Outcome Measures

Immunogenicity and interchangeability of two inactivated hepatitis A vaccines

Secondary Outcome Measures

safety of two inactivated hepatitis A vaccines

Full Information

NCT ID

NCT01252680

First Posted

November 29, 2010

Last Updated

March 13, 2013

Sponsor

Sinovac Biotech Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01252680

Brief Title

Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines

Official Title

A Randomized, Double-blind Clinical Trial of Two Inactivated Hepatitis A Vaccines in Healthy Children

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

February 2011 (Actual)

Study Completion Date

May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sinovac Biotech Co., Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a randomized, double-blind clinical trial of two inactivated hepatitis A vaccines in healthy children, immunogenicity and interchangeability of the two inactivated hepatitis A vaccines were evaluated.

Detailed Description

This was a monocenter, comparative trial in which healthy children were randomized to receive two doses of hepatitis A vaccine 6 months apart. The trial was conducted in accordance with the Edinburgh version of the Declaration of Helsinki. The study was approved by the Ethics Committee. Parents or legal guardians of all participants gave written informed consent prior to study entry. Eligible subjects were between 18m and 6 years of age, When enrolled, children were randomized to four equal groups with different intervention. Immunogenicity and interchangeability of two inactivated hepatitis A vaccines were evaluated.

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

Crossover Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

303 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Healive+Healive

Arm Type

Experimental

Arm Description

75 subjects to receive two doses of Healive 6 months apart

Arm Title

Group 2: Healive+Havrix

Arm Type

Experimental

Arm Description

75 subjects to receive one dose of Healive and another dose of Havrix 6 months apart

Arm Title

Group 3: Havrix+Havrix

Arm Type

Experimental

Arm Description

75 subjects to receive two doses of Havrix 6 months apart

Arm Title

Group 4: Havrix+Healive

Arm Type

Experimental

Arm Description

75 subjects to receive one dose of Havrix and another dose of Healive 6 months apart

Intervention Type

Biological

Intervention Name(s)

Healive+Healive

Other Intervention Name(s)

Hepatitis A vaccine

Intervention Description

Hepatitis A vaccine (Healive), 250 u per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart

Intervention Type

Biological

Intervention Name(s)

Healive+Havrix

Other Intervention Name(s)

Hepatitis A vaccine

Intervention Description

Two kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Healive, followed by another dose of Havrix after 6 months

Intervention Type

Biological

Intervention Name(s)

Havrix+Havrix

Other Intervention Name(s)

Hepatitis A vaccine

Intervention Description

Hepatitis A vaccine (Havrix), 720 ELU per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart

Intervention Type

Biological

Intervention Name(s)

Havrix+Healive

Other Intervention Name(s)

Hepatitis A vaccine

Intervention Description

Two kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Havrix, followed by another dose of Healive after 6 months

Primary Outcome Measure Information:

Title

Immunogenicity and interchangeability of two inactivated hepatitis A vaccines

Time Frame

7 months

Secondary Outcome Measure Information:

Title

safety of two inactivated hepatitis A vaccines

Time Frame

7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Months

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy children aged between 1.5 and 5 years, with no history of hepatitis A virus infection or hepatitis A vaccine vaccination Provided birth certification or vaccination card Parent(s) or legal guardian(s) are able to understand and sign the informed consent Exclusion Criteria: Axillary temperature > 37.0 centigrade at the time of dosing Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain Autoimmune disease or immunodeficiency Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders) Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws History or family history of convulsions, epilepsy, brain disease and psychiatric History of any blood products within 3 months Administration of any other investigational research agents within 30 days Administration of any live attenuated vaccine within 30 days Administration of subunit or inactivated vaccines within 14 days Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhi-lun Zhang

Organizational Affiliation

Tianjin Centers for Diseases Control and Prevention

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tianjin Centers for Diseases Control and Prevention

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300011

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

22537990

Citation

Zhang ZL, Zhu XJ, Wang X, Liang M, Sun J, Liu Y, Gao ZG, Wu JY, Dong XJ, Liu RK, Chen JT, Zhang YQ, Wang W, Zhang LP, Yin W. Interchangeability and tolerability of two inactivated hepatitis A vaccines in Chinese children. Vaccine. 2012 Jun 8;30(27):4028-33. doi: 10.1016/j.vaccine.2012.04.038. Epub 2012 Apr 23.

Results Reference

derived

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Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines

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