Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

PHASE4CompletedINTERVENTIONAL
Enrollment

13,500

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

June 30, 2014

Study Completion Date

October 31, 2015

Conditions
Hepatitis A
Interventions
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

Trial Locations (2)

210009

Jiangsu Provincial Center for Disease Control and Prevention, Nanjing

650118

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

All Listed Sponsors
collaborator

Institute of Medical Biology, Chinese Academy of Medical Sciences

OTHER

lead

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

NCT02601040 - Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines | Biotech Hunter | Biotech Hunter