NCT02601040

Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

Phase IV Clinical Trial to Assess the Safety, Immunogenicity,Three-year Immune Persistence of Inactivated Hepatitis A Vaccine (HAV) and Live Attenuated HAV Vaccine in Health Chinese Children and Adult

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 13,500 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: 18 Months – 65 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study was to evaluate the safety and immunogenicity of Immunogenicity of Inactivated and Live Attenuated Hepatitis A Vaccines for healthy Chinese people.

Conditions

• Hepatitis A

Interventions

Type	Name	Description
BIOLOGICAL	Attenuated Hepatitis A Vaccine, H2 Strain	6.50 lgCCID50/ml in babies aged 18-35 months\\6.50 lgCCID50/ml in children aged 3-16 years \\6.50 lgCCID50/ml in adults aged 17 up to 65 years old
BIOLOGICAL	Inactivated Hepatitis A Vaccine, Lu8 Strain	320EU/Vial in babies aged 18-35 months \\320EU/Vial in children aged 3-16 years \\640EU/Vial in adults aged 17 up to 65 years old\\boost at month 6\\two-dose
BIOLOGICAL	Group A Meningococcal Polysaccharide vaccine	30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-06-01
• Completion: 2015-10-01
• First posted: 2015-11-10
• Last updated: 2015-11-10

Locations

2 sites across 1 country: China