Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier:
NCT01252680
First received: November 29, 2010
Last updated: March 13, 2013
Last verified: March 2013

November 29, 2010
March 13, 2013
April 2010
February 2011   (final data collection date for primary outcome measure)
Immunogenicity and interchangeability of two inactivated hepatitis A vaccines [ Time Frame: 7 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01252680 on ClinicalTrials.gov Archive Site
safety of two inactivated hepatitis A vaccines [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines
A Randomized, Double-blind Clinical Trial of Two Inactivated Hepatitis A Vaccines in Healthy Children

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Hepatitis A
  • 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
    Other Name: Hepatitis A vaccine
  • 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
    Other Name: Hepatitis A vaccine
  • 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
    Other Name: Hepatitis A vaccine
  • 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
    Other Name: Hepatitis A vaccine
  • Experimental: Group 1: Healive+Healive
    75 subjects to receive two doses of Healive 6 months apart
    Intervention: Biological: Healive+Healive
  • Experimental: Group 2: Healive+Havrix
    75 subjects to receive one dose of Healive and another dose of Havrix 6 months apart
    Intervention: Biological: Healive+Havrix
  • Experimental: Group 3: Havrix+Havrix
    75 subjects to receive two doses of Havrix 6 months apart
    Intervention: Biological: Havrix+Havrix
  • Experimental: Group 4: Havrix+Healive
    75 subjects to receive one dose of Havrix and another dose of Healive 6 months apart
    Intervention: Biological: Havrix+Healive
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
May 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Months to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01252680
PRO-HA-4014
No
Sinovac Biotech Co., Ltd
Sinovac Biotech Co., Ltd
Not Provided
Principal Investigator: Zhi-lun Zhang Tianjin Centers for Diseases Control and Prevention
Sinovac Biotech Co., Ltd
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP