Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01865968
Other study ID # PRO-HA-4009
Secondary ID
Status Completed
Phase Phase 4
First received May 28, 2013
Last updated May 13, 2015
Start date October 2008
Est. completion date September 2012

Study information

Verified date May 2013
Source Sinovac Biotech Co., Ltd
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 239
Est. completion date September 2012
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 16 Years to 25 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
China Nanchang Center for Disease prevention and Control Nanchang Jiangxi

Sponsors (1)

Lead Sponsor Collaborator
Sinovac Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary reported side effects and adverse events After each dose, solicited injection-site and general adverse events (AEs) were recorded for 7 days and unsolicited AEs were recorded for 28 days. 37 months Yes
See also
  Status Clinical Trial Phase
Withdrawn NCT03445416 - Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men N/A
Completed NCT01949857 - The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines Phase 4
Completed NCT00313950 - Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine Phase 4
Completed NCT00197171 - Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine Phase 3
Completed NCT00139139 - A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A N/A
Completed NCT00139113 - Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children Phase 4
Completed NCT03312699 - Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Phase 1
Completed NCT03855176 - Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients Phase 4
Completed NCT00197002 - Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age Phase 3
Withdrawn NCT02605538 - Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively N/A
Completed NCT04638335 - What is the Anti-HAV Seroprevalence of Travelers >60 Years or Having Lived in a Tropical Country for >5 Years
Completed NCT00197015 - Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children Phase 3
Active, not recruiting NCT06058416 - Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old Phase 4
Completed NCT01453348 - Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine Phase 3
Completed NCT02002065 - The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children N/A
Terminated NCT00119743 - A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine Phase 3
Completed NCT01000324 - Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix Adult Phase 4
Completed NCT00289731 - Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc Phase 4
Completed NCT02300792 - The Effects of Honey, as a Dietary Supplement in Children With Hepatitis A Phase 2
Completed NCT02601040 - Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines Phase 4