NCT01949857

The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

Phase 4 Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 35,000 (actual)
• Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Months – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this Phase 4 trial is to assess the safety, immunogenicity, three-year immune persistence of inactivated hepatitis A vaccine (HAV) and live attenuated HAV vaccine.

Detailed description

Hepatitis A refers to liver inflammation caused by infection with the hepatitis A virus. HAV is is one of the most common hepatitis viruses that can cause hepatitis in China. The data from the phase 1, 2 and 3 trials suggested that both inactivated hepatitis A vaccine and live attenuated hepatitis A vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese people.

Conditions

• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Attenuated HAV Vaccine, H2 Strain	6.50 lgCCID50/Vial in babies aged 18-35 months\\6.50 lgCCID50/Vial in children aged 3-15 years \\6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).
BIOLOGICAL	Attenuated HAV Vaccine, L-A-1 Strain	6.50 lgCCID50/Vial in babies aged 18-35 months\\6.50 lgCCID50/Vial in children aged 3-15 years \\6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).
BIOLOGICAL	Inactivated HAV Vaccine, Lu8 Strain	320EU/Vial in babies aged 18-35 months\\320EU/Vial in children aged 3-15 years \\640EU/Vial in adults aged 16 up to 65 years old\\boost at month 6\\two-dose
BIOLOGICAL	Inactivated HAV Vaccine, TZ84 Strain	250U/Vial in babies aged 18-35 months\\250U/Vial in children aged 3-15 years \\500U/Vial in adults aged 16 up to 65 years old\\boost at month 6\\two-dose.

Timeline

• Start date: 2013-09-01
• Primary completion: 2015-12-01
• Completion: 2016-06-01
• First posted: 2013-09-25
• Last updated: 2023-10-10

Locations

1 site across 1 country: China