Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults
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.
1 other identifier
interventional
239
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2008
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 28, 2013
CompletedFirst Posted
Study publicly available on registry
May 31, 2013
CompletedMay 14, 2015
May 1, 2013
3.2 years
May 28, 2013
May 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
concentration of antibody to hepatitis A virus
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.
37 months
Secondary Outcomes (1)
reported side effects and adverse events
37 months
Study Arms (3)
Inactivated HAV vaccine
EXPERIMENTALHealthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with one-dose regimen.
Live attenuated HAV vaccine
ACTIVE COMPARATORHealthy 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.
Two-dose inactivated HAV vaccine
EXPERIMENTALHealthy undergraduate students aged 16 to 25 years with anti-HAV negative received inactivated HAV vaccine containing 500u/vial with two-dose regimen.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Healthy undergraduate students aged 16 to 25 years
- Sign the informed consent
- Provide ID
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanchang Center for Disease prevention and Control
Nanchang, Jiangxi, 330000, China
Related Publications (1)
Liu XE, Chen HY, Liao Z, Zhou Y, Wen H, Peng S, Liu Y, Li R, Li J, Zhuang H. Comparison of Immunogenicity Between Inactivated and Live Attenuated Hepatitis A Vaccines Among Young Adults: A 3-Year Follow-up Study. J Infect Dis. 2015 Oct 15;212(8):1232-6. doi: 10.1093/infdis/jiv213. Epub 2015 May 12.
PMID: 25969561DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hui Zhuang, Ph.D, MD
Medical school of Peking University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2013
First Posted
May 31, 2013
Study Start
October 1, 2008
Primary Completion
December 1, 2011
Study Completion
September 1, 2012
Last Updated
May 14, 2015
Record last verified: 2013-05