ClinicalTrials.gov
ClinicalTrials.gov Menu

Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01252680
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : March 15, 2013
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Hepatitis A Biological: Healive+Healive Biological: Healive+Havrix Biological: Havrix+Havrix Biological: Havrix+Healive Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 303 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind Clinical Trial of Two Inactivated Hepatitis A Vaccines in Healthy Children
Study Start Date : April 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: Healive+Healive
75 subjects to receive two doses of Healive 6 months apart
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

Experimental: Group 2: Healive+Havrix
75 subjects to receive one dose of Healive and another dose of Havrix 6 months apart
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

Experimental: Group 3: Havrix+Havrix
75 subjects to receive two doses of Havrix 6 months apart
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

Experimental: Group 4: Havrix+Healive
75 subjects to receive one dose of Havrix and another dose of Healive 6 months apart
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




Primary Outcome Measures :
  1. Immunogenicity and interchangeability of two inactivated hepatitis A vaccines [ Time Frame: 7 months ]

Secondary Outcome Measures :
  1. safety of two inactivated hepatitis A vaccines [ Time Frame: 7 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01252680


Locations
China, Tianjin
Tianjin Centers for Diseases Control and Prevention
Tianjin, Tianjin, China, 300011
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
Principal Investigator: Zhi-lun Zhang Tianjin Centers for Diseases Control and Prevention

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT01252680     History of Changes
Other Study ID Numbers: PRO-HA-4014
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: March 15, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs