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Trial record 28 of 7435 for:    vaccination

Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults

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ClinicalTrials.gov Identifier: NCT01865968
Recruitment Status : Completed
First Posted : May 31, 2013
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd

Brief Summary:
A phase IV, randomization, single center, controlled clinical trial to compare the safety, immunogenicity,three-year immune persistence of inactivated hepatitis A vaccine (HAV) with one- or two-dose regimen and live attenuated HAV with one-dose regimen in Chinese young adults, and to evaluate the immunogenicity of a booster dose.

Condition or disease Intervention/treatment Phase
Hepatitis A Biological: Inactivated HAV vaccine Biological: Live attenuated HAV vaccine Phase 4

Detailed Description:
Healthy undergraduate students aged 16 to 25 years with anti-HAV negative were randomly divided into three groups. Group A and B were administrated with one-dose inactivated and live attenuated hepatitis A vaccines respectively; Group C was immunized with two doses of an inactivated vaccine with 6 months apart. Blood samples were collected at month 1, and 12, 24 and 36 for anti-HAV titers determination. Safety observation in 30 minutes' duration after vaccinations and injection-site reactions and systemic reactions for three consecutive days were recorded to assess the safety of investigational vaccines. At Month 36, subjects who received one dose of inactivated or live attenuated HAV were administrated a booster dose and then were taken blood samples one month later for anti-HAV titers determination.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase IV Trial to Compare the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) With One- or Two-dose Regimen and Live Attenuated HAV With One-dose Regimen in Chinese Young Adults, and to Evaluate the Immunogenicity of a Booster Dose.
Study Start Date : October 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Inactivated HAV vaccine
Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with one-dose regimen.
Biological: Inactivated HAV vaccine
Hepatitis A vaccine (Healive), 500 u per dose per 0.5 millilitre. Vaccines will be administered with one-dose or two-dose regimen of the arm 6 months apart in the deltoid muscle.
Other Name: Inactivated hepatitis A vaccines

Active Comparator: Live attenuated HAV vaccine
Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received live attenuated HAV vaccine containing 6.50 lgCCID50/vial with one-dose regimen.
Biological: Live attenuated HAV vaccine
Live attenuated hepatitis A vaccine, 6.50 lgCCID50 per dose per 0.5 millilitre. Vaccines will be administered with one-dose regimen in the deltoid muscle.
Other Name: Live attenuated hepatitis A vaccines

Experimental: Two-dose inactivated HAV vaccine
Healthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with two-dose regimen.
Biological: Inactivated HAV vaccine
Hepatitis A vaccine (Healive), 500 u per dose per 0.5 millilitre. Vaccines will be administered with one-dose or two-dose regimen of the arm 6 months apart in the deltoid muscle.
Other Name: Inactivated hepatitis A vaccines




Primary Outcome Measures :
  1. concentration of antibody to hepatitis A virus [ Time Frame: 37 months ]
    Anti-HAV antibody geometric mean concentrations pre-vaccination, and at month 1, and 12, 24 and 36, and 1 months (month 37) after the booster vaccination.


Secondary Outcome Measures :
  1. reported side effects and adverse events [ Time Frame: 37 months ]
    After each dose, solicited injection-site and general adverse events (AEs) were recorded for 7 days and unsolicited AEs were recorded for 28 days.



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Ages Eligible for Study:   16 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy undergraduate students aged 16 to 25 years
  • Sign the informed consent
  • Provide ID

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
  • anti-HBsAg positive
  • anti-HAV positive
  • Pregnancy test result is positive

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): NCT01865968


Locations
China, Jiangxi
Nanchang Center for Disease prevention and Control
Nanchang, Jiangxi, China, 330000
Sponsors and Collaborators
Sinovac Biotech Co., Ltd
Investigators
Principal Investigator: Hui Zhuang, Ph.D, MD Medical school of Peking University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sinovac Biotech Co., Ltd
ClinicalTrials.gov Identifier: NCT01865968     History of Changes
Other Study ID Numbers: PRO-HA-4009
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2013

Keywords provided by Sinovac Biotech Co., Ltd:
inactivated HAV vaccine; live attenuated HAV vaccine; immunogenicity; safety

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