Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hepatitis A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1: Healive+Healive

75 subjects to receive two doses of Healive 6 months apart

Group Type EXPERIMENTAL

Healive+Healive

Intervention Type BIOLOGICAL

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

Group 2: Healive+Havrix

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

Group Type EXPERIMENTAL

Healive+Havrix

Intervention Type BIOLOGICAL

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

Group 3: Havrix+Havrix

75 subjects to receive two doses of Havrix 6 months apart

Group Type EXPERIMENTAL

Havrix+Havrix

Intervention Type BIOLOGICAL

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

Group 4: Havrix+Healive

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

Group Type EXPERIMENTAL

Havrix+Healive

Intervention Type BIOLOGICAL

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

Interventions

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Healive+Healive

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

Healive+Havrix

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

Havrix+Havrix

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

Havrix+Healive

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

Intervention Type BIOLOGICAL

Other Intervention Names

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Hepatitis A vaccine Hepatitis A vaccine Hepatitis A vaccine Hepatitis A vaccine

Eligibility Criteria

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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

Minimum Eligible Age

18 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes