DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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


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.


Minimum age: 18 Months. Maximum age: 5 Years. Gender(s): Both.


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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017