The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children

The Phase IV, Open-labelled, Follow-up Study to Evaluate the Five-year Immune Persistence of One Injection of Inactivated or Attenuated Alive Hepatitis A Vaccine in Healthy Chinese Children

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02002065

Enrollment

332

Registered

2013-12-05

Start date

2008-10-31

Completion date

2014-06-30

Last updated

2016-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis A

Keywords

hepatitis A, inactivated hepatitis A vaccine, attenuated alive hepatitis A vaccine, immune persistence

Brief summary

The purpose of this follow-up study is to evaluate the five-year immune persistence of one injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.

Detailed description

In the previous double-blind, randomized, phase IV clinical trial in 2008, 300 healthy Chinese children aged 18 to 35 months old were administered with one dose of inactivated and attenuated alive hepatitis A vaccine. Series of serum samples were taken for immunogenicity and immune persistence evaluation. Safety observations were performed after vaccination. This trial was also approved by Tianjin CDC Biomedical Ethics Committee in 2008. This study is the fifth-year follow-up research for the previous clinical trial.

Interventions

BIOLOGICALInactivated HAV vaccine

Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose

BIOLOGICALAttenuated alive HAV vaccine

Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Months to 35 Months

Healthy volunteers

Yes

Inclusion criteria

* All subjects who received inactivated or attenuated alive HAV vaccine in the previous trial

Exclusion criteria

* Subjects who refused to continue in the follow-up study

Design outcomes

Primary

Measure	Time frame	Description
The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination	60 months after vaccination	to evaluate the immune persistence of anti-HAV antibodies in serum

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026