Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines

Hepatitis A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01252680
• Other study ID #: PRO-HA-4014
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2010
• Last updated: March 13, 2013
• Start date: April 2010
• Est. completion date: May 2011

Study information

• Verified date: March 2013
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: May 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A

Intervention

Biological:
• 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
• 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
• 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
• 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

Locations

Country	Name	City	State
China	Tianjin Centers for Diseases Control and Prevention	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity and interchangeability of two inactivated hepatitis A vaccines		7 months	No
Secondary	safety of two inactivated hepatitis A vaccines		7 months	Yes