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Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines

NCT02601040 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 13500

Last updated 2015-11-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

    collaborator OTHER

  • Jiangsu Province Centers for Disease Control and Prevention

    lead NETWORK

Principal Investigators

  • Jingsi Yang, PhD · Institude of Medical Biology, Chinese Academy of Medical Sciences

  • Fubao Ma · Jiangsu Provincial Center for Disease Control and Prevention

  • Qiangming Sun, PhD · Institude of Medical Biology, Chinese Academy of Medical Sciences

  • Guodong Kang · Jiangsu Provincial Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-06-30
Completion
2015-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02601040 on ClinicalTrials.gov