NCT00197184

Brief Summary

To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of the study vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
276

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2003

Shorter than P25 for phase_3

Geographic Reach
3 countries

7 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, 2003

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

June 4, 2009

Completed
Last Updated

August 20, 2018

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

September 15, 2005

Results QC Date

February 20, 2009

Last Update Submit

July 2, 2018

Conditions

Hepatitis BHepatitis A

Keywords

Combined hepatitis A and B vaccineTwinrix™

Outcome Measures

Primary Outcomes (4)

  • Anti-hepatitis A (HAV) Antibody Concentrations

    Geometric mean concentration for anti-HAV antibodies expressed as Milli-International Units per milliliter (mIU/mL)

    Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)

  • Anti-hepatitis B (HBs) Antibody Concentrations

    Geometric mean concentration for anti-HBs antibodies expressed as Milli-International Units per milliliter (mIU/mL).

    Year 2 (Month 24), Year 3 (Month 36), Year 4 (Month 48) and Year 5 (Month 60)

  • Anti-HAV Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.

    Any subjects becoming seronegative for anti-HAV antibodies (i.e. titres \< 15 mIU/ml) at any long term time point, were to receive an additional vaccine dose administered between 6 to 12 months after Year 5 time point.

    Before and one month after additional vaccination

  • Anti-HBs Antibody Concentrations in Subjects Receiving the Additional Vaccine Dose.

    Subjects losing seroprotective anti-HBs antibody titres (i.e. titres \< 10 mIU/ml) at any long term time point, received an Engerix challenge dose. The table presents the geometric mean concentrations for anti-HBs antibodies, expressed as Milli-International Units per milliliter (mIU/mL).

    Before and One month after additional vaccination

Secondary Outcomes (5)

  • Number of Subjects Reporting Serious Adverse Events (SAEs) Determined by the Investigator to Have a Causal Relationship to Primary Vaccination or Due to Lack of Vaccine Efficacy.

    From last study visit of the primary study up to Year 5 long term follow-up

  • Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited Local Symptoms

    during the 4-day follow-up period after additional vaccination

  • Number of Subjects Receiving an Additional Vaccine Dose and Reporting Solicited General Symptoms.

    During the 4-day follow-up period after additional vaccination

  • Number of Subjects Receiving an Additional Vaccine Dose and Reporting Unsolicited Adverse Events (AEs).

    During the 30-day follow-up period after additional vaccination.

  • Number of Subjects Receiving an Additional Vaccine Dose and Reporting Any Serious Adverse Events

    At least one month after additional vaccination

Study Arms (2)

Twinrix Junior

EXPERIMENTAL

Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).

Biological: Twinrix™ Junior

Twinrix Adult

ACTIVE COMPARATOR

Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).

Biological: Twinrix™ Adult

Interventions

Twinrix™ AdultBIOLOGICAL

Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.

Also known as: Combined hepatitis A and B vaccine
Twinrix Adult
Twinrix™ JuniorBIOLOGICAL

Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.

Also known as: Combined hepatitis A and B vaccine
Twinrix Junior

Eligibility Criteria

Age3 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Participation in primary study
  • Written informed consent obtained before each long term follow up visit.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

GSK Investigational Site

North Adelaide, South Australia, 5006, Australia

Location

GSK Investigational Site

Carlton, Victoria, 3053, Australia

Location

GSK Investigational Site

Brussels, 1200, Belgium

Location

GSK Investigational Site

Barcelona, 08042, Spain

Location

GSK Investigational Site

Blanes (Girona), 17300, Spain

Location

GSK Investigational Site

Cerdanyola Del Vallés / Barcelona, 08290, Spain

Location

GSK Investigational Site

Valencia, 46024, Spain

Location

Related Publications (1)

  • Marshall H, Nolan T, Diez Domingo J, Rombo L, Sokal EM, Mares J, Casanovas JM, Kuriyakose S, Leyssen M, Jacquet JM. Long-term (5-year) antibody persistence following two- and three-dose regimens of a combined hepatitis A and B vaccine in children aged 1-11 years. Vaccine. 2010 Jun 17;28(27):4411-5. doi: 10.1016/j.vaccine.2010.04.040. Epub 2010 Apr 29.

    PMID: 20434544BACKGROUND

Related Links

MeSH Terms

Conditions

Hepatitis BHepatitis A

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesEnterovirus InfectionsPicornaviridae InfectionsRNA Virus Infections

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 20, 2005

Study Start

November 1, 2003

Primary Completion

March 10, 2004

Study Completion

March 10, 2004

Last Updated

August 20, 2018

Results First Posted

June 4, 2009

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will share

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Available IPD Datasets

Dataset Specification (208127/132 (EXT Y2))Access
Study Protocol (208127/132 (EXT Y2))Access
Statistical Analysis Plan (208127/132 (EXT Y2))Access
Clinical Study Report (208127/132 (EXT Y2))Access
Informed Consent Form (208127/132 (EXT Y2))Access
Individual Participant Data Set (208127/132 (EXT Y2))Access

Locations

AU(2)BE(1)ES(4)