NCT02601040

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,500

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
Last Updated

November 10, 2015

Status Verified

October 1, 2015

Enrollment Period

2.6 years

First QC Date

October 25, 2015

Last Update Submit

November 6, 2015

Conditions

Hepatitis A

Keywords

SafetyImmunogenicityVaccineHepatitis A

Outcome Measures

Primary Outcomes (1)

  • Changes of hepatitis A antibody concentration

    Changes of anti Hepatitis A antibody geometric mean concentrations at pre-vaccination, month 1,12, 24, 36, and 1 months after the booster vaccination.

    37 months

Secondary Outcomes (1)

  • Incidence of adverse events

    28 days

Study Arms (3)

Attenuated Hepatitis A Vaccine, H2 Strain

EXPERIMENTAL

Health subjects received attenuated Hepatitis A vaccine intramuscularly in the deltoid region.

Biological: Attenuated Hepatitis A Vaccine, H2 Strain

Inactivated Hepatitis A Vaccine, Lu8 Strain

EXPERIMENTAL

Health subjects received inactivated Hepatitis A vaccine intramuscularly in the deltoid region.

Biological: Inactivated Hepatitis A Vaccine, Lu8 Strain

Group A Meningococcal Polysaccharide vaccine

PLACEBO COMPARATOR

Health subjects received Group A Meningococcal Polysaccharide vaccine intramuscularly in the deltoid region.

Biological: Group A Meningococcal Polysaccharide vaccine

Interventions

Attenuated Hepatitis A Vaccine, H2 StrainBIOLOGICAL

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

Attenuated Hepatitis A Vaccine, H2 Strain
Inactivated Hepatitis A Vaccine, Lu8 StrainBIOLOGICAL

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

Inactivated Hepatitis A Vaccine, Lu8 Strain
Group A Meningococcal Polysaccharide vaccineBIOLOGICAL

30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old

Group A Meningococcal Polysaccharide vaccine

Eligibility Criteria

Age18 Months - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Only subjects fulfilling all of the following criteria will be eligible for the study:
  • People aged from 18 months to 65 years old.
  • The subjects or subjects' guardians are able to understand and sign the informed consent
  • The subjects or subjects' guardians allow to comply with the requirements of the protocol
  • Subjects with temperature \<=37.0°C on axillary setting
  • The subjects have signed informed consent already

You may not qualify if:

  • Subjects will not be eligible for the study if any of the following criteria is met:
  • Subject who has a medical history of serious disease including Tumor, autoimmune disease, progressive atherosclerosis diseases or complications of diabetes, chronic obstructive pulmonary disease (copd), kidney disease, congestive heart failure etc.
  • Have a history of neurological symptoms or signs
  • Have medical history or family history relating to allergies, seizures, epilepsy, brain and spirit etc.
  • Suffering from serious chronic diseases
  • Suffering from known or suspected of diseases including respiratory diseases, acute infection , mothers have HIV infection, cardiovascular disease, severe hypertension, skin diseases, malignant tumor
  • Allergic to any ingredient in research, history of allergies to any vaccination (always), especially for people allergic to high protein food like eggs and milk
  • Any prior known or suspected damage or abnormal immune function. As for patients who are treated with immune inhibitors or immune enhancer medicine, accept with immunoglobin, blood products and plasma extraction within 3 months
  • Any prior diseases including human immunodeficiency virus infection or related
  • Bleeding constitution or prolong bleeding time situation
  • Accept hepatitis A vaccination within a month
  • Received vaccines, other immune globulin, any research drug injections in the past 4 weeks
  • People who had any acute illness, needed systemic antibiotics or antiviral treatment in the past 7 days
  • Caught a fever with axillary temperature 38°C or higher in past 3 days
  • Take part in another clinical researchers
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, Jiangsu, 210009, China

Location

Institute of Medical Biology -Chinese Academy of Medical Sciences

Kunming, Yunnan, 650118, China

Location

Related Publications (1)

  • Wang X, Luo J, Ma F, Kang G, Ding Z, Pan Y, Zhao Y, Chen J, Feng K, Yan L, Zhang J, Li L, Lan Q, Li D, Yang X, Li G, Yang J, Sun Q. The Safety, Immunogenicity, and Immunopersistence of Hepatitis A Vaccine in HBs-Ag-Positive Participants: A Retrospective Study. Front Cell Infect Microbiol. 2021 Jun 17;11:672221. doi: 10.3389/fcimb.2021.672221. eCollection 2021.

    PMID: 34222044DERIVED

MeSH Terms

Conditions

Hepatitis A

Condition Hierarchy (Ancestors)

Hepatitis, Viral, HumanVirus DiseasesInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Jingsi Yang, PhD

    Institude of Medical Biology, Chinese Academy of Medical Sciences

    STUDY CHAIR

  • Fubao Ma

    Jiangsu Provincial Center for Disease Control and Prevention

    STUDY DIRECTOR

  • Qiangming Sun, PhD

    Institude of Medical Biology, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

  • Guodong Kang

    Jiangsu Provincial Center for Disease Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2015

First Posted

November 10, 2015

Study Start

November 1, 2011

Primary Completion

June 1, 2014

Study Completion

October 1, 2015

Last Updated

November 10, 2015

Record last verified: 2015-10

Locations

CN(2)