NCT00534885

Brief Summary

A double-blind, randomized and controlled clinical trial was conducted in healthy children aged from 1 to 8 years to evaluate the immunogenicity and safety of three consecutive lots of a preservative-free inactivated hepatitis A vaccine (Healive®). Participants who completed their primary vaccination were invited to participate in the follow-up phase. Written informed consents were obtained from them. The follow-up study was open-label. These subjects were visited in the next 11 years for blood sampling and assessment of immune persistence induced by vaccination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

September 4, 2019

Status Verified

August 1, 2019

Enrollment Period

11.6 years

First QC Date

September 24, 2007

Last Update Submit

August 29, 2019

Conditions

Hepatitis A

Keywords

inactivated hepatitis A vaccineHealivesafetyimmunogenicityimmune persistence

Outcome Measures

Primary Outcomes (1)

  • Anti-HAV titer

    To evaluate the immune responses to the inactivated hepatitis A vaccine by detecting the anti-HAV titer using microparticle enzyme immunoassay (MEIA) assay.

    7 months after the first dose

Secondary Outcomes (3)

  • Solicited adverse reactions (AE): local reactions and systematic reactions

    72 hours after each injection

  • Unsolicited adverse reactions (AE)

    7 months after the first dose

  • Change of anti-HAV titer: geometry mean titer(GMT) and seroconversion rate

    baseline (day 0), month 1, 6, 7, 18, 30, 42, 54, 66,112,138 after the first dose

Study Arms (4)

1: Healive® Lot 1

EXPERIMENTAL
Biological: Healive® Lot 1

2: Healive® Lot 2

EXPERIMENTAL
Biological: Healive® Lot 2

3: Healive® Lot 3

EXPERIMENTAL
Biological: Healive® Lot 3

4: control vaccine (Havrix)

ACTIVE COMPARATOR
Biological: Havrix

Interventions

Healive® Lot 1BIOLOGICAL

Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart

1: Healive® Lot 1
Healive® Lot 2BIOLOGICAL

Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart

2: Healive® Lot 2
Healive® Lot 3BIOLOGICAL

Inactivated hepatitis A vaccine manufactured by Sinovac Biotech Co., Ltd.; two-dose regimen with 6 months apart

3: Healive® Lot 3
HavrixBIOLOGICAL

Inactivated hepatitis A vaccine manufactured by GlaxoSmithKline Biologicals; two-dose regimen with 6 months apart

4: control vaccine (Havrix)

Eligibility Criteria

Age12 Months - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Health children from 1 to 10 years
  • Not participate in any other trial during the course of the trial
  • Informed consent

You may not qualify if:

  • Any history of allergic reactions or convulsions following vaccination
  • Other known or planned vaccination within 1 month prior to the study and during the study period
  • Any chronic illness/disease including virus hepatitis, tuberculosis and epilepsy
  • Presence of any congenital abnormality, upgrowth obstacle
  • Any history/suspicion/presence of neurology and Lunacy
  • Any current or foreseeable use of immunosuppressors (i.e. corticosteroids , immunoglobulins) within 1 month prior to the vaccination and during the period of the study
  • Contraindication to intramuscularly injection due to thrombocytopenia or other bleeding disorders
  • Abnormal ALT
  • Positive markers for anti-HAV and HBV（HBsAg）infection
  • Presence of fever at the time of vaccination, i.e. body temperature (by mouth) \> 37.0 centigrade.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changzhou City Center for Disease Control and Prevention

Changzhou, Jiangsu, 213003, China

Location

MeSH Terms

Conditions

Hepatitis A

Interventions

Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Hepatitis VaccinesViral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Wen-Yu Chen

    Changzhou City Centre for Diseases Control and Prevention

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 24, 2007

First Posted

September 26, 2007

Study Start

March 1, 2006

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

September 4, 2019

Record last verified: 2019-08

Locations

CN(1)