Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines
Information source: Sinovac Biotech Co., Ltd
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis A
Intervention: Healive+Healive (Biological); Healive+Havrix (Biological); Havrix+Havrix (Biological); Havrix+Healive (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: Sinovac Biotech Co., Ltd Official(s) and/or principal investigator(s): Zhi-lun Zhang, Principal Investigator, Affiliation: Tianjin Centers for Diseases Control and Prevention
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.
Clinical Details
Official title: A Randomized, Double-blind Clinical Trial of Two Inactivated Hepatitis A Vaccines in Healthy Children
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Primary outcome: Immunogenicity and interchangeability of two inactivated hepatitis A vaccines
Secondary outcome: safety of two inactivated hepatitis A vaccines
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
Minimum age: 18 Months.
Maximum age: 5 Years.
Gender(s): Both.
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
Locations and Contacts
Tianjin Centers for Diseases Control and Prevention, Tianjin, Tianjin 300011, China
Additional Information
Starting date: April 2010
Last updated: March 13, 2013
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