Hepatitis A Clinical Trial
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.
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.
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. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Withdrawn |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 |
NCT00139139 -
A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A
|
N/A | |
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 |
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 |