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

NCT01949857 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 35000

Last updated 2023-10-10

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Jiangsu Province Centers for Disease Control and Prevention

    collaborator NETWORK

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Qihan Li, Ph.D. · Institude of Medical Biology, Chinese Academy of Medical Sciences

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

  • Qiangming Sun, Ph.D. · Institude of Medical Biology, Chinese Academy of Medical Sciences

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

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-12-31
Completion
2016-06-30

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 NCT01949857 on ClinicalTrials.gov