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
  Purpose

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 Intervention Phase
Hepatitis A
Biological: Healive+Healive
Biological: Healive+Havrix
Biological: Havrix+Havrix
Biological: Havrix+Healive
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind Clinical Trial of Two Inactivated Hepatitis A Vaccines in Healthy Children

Resource links provided by NLM:


Further study details as provided by Sinovac Biotech Co., Ltd:

Primary Outcome Measures:
  • Immunogenicity and interchangeability of two inactivated hepatitis A vaccines [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety of two inactivated hepatitis A vaccines [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment: 303
Study Start Date: April 2010
Study Completion Date: May 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Months to 5 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Sinovac Biotech Co., Ltd

Additional 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
Study First Received: November 29, 2010
Last Updated: March 13, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on September 22, 2014