NCT01865968

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.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Sinovac Biotech Co., Ltd · Industry
• Sex: All
• Age: 16 Years – 25 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Hepatitis A

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-12-01
• Completion: 2012-09-01
• First posted: 2013-05-31
• Last updated: 2015-05-14

Locations

1 site across 1 country: China