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

PHASE4CompletedINTERVENTIONAL
Enrollment

35,000

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

December 31, 2015

Study Completion Date

June 30, 2016

Conditions
Hepatitis A
Interventions
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.

Trial Locations (1)

650118

Institute of Medical Biology -Chinese Academy of Medical Sciences, Kunming

All Listed Sponsors
collaborator

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

lead

Institute of Medical Biology, Chinese Academy of Medical Sciences

OTHER

NCT01949857 - The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines | Biotech Hunter | Biotech Hunter