Immuno & Safety Study of GSK Biologicals' Thio or Preservative Free Hepatitis B Vaccine in Subjects Aged 11-15 Yrs

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-21

Study Completion Date

2008-01-10

Brief Summary

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To evaluate the persistence of antibodies against hepatitis B at 30, 42, 54 and 66 months after the first dose of the hepatitis B primary vaccination course.

Subjects were aged 11 to 15 years at the time of the primary vaccination course.

At the time of enrollment in the present long-term follow-up study subjects were aged 13 to 18 years.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

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Detailed Description

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All subjects who participated in the primary study, in which they received either 2 or 3 doses of GSK Biologicals hepatitis B vaccine, and who consented to participate in the long-term follow-up at Month 42 were contacted by the investigators.

No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.

Conditions

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Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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2-Dose Engerix

subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.

Group Type EXPERIMENTAL

Engerix™-B (thiomersal-free) 20µg

Intervention Type BIOLOGICAL

In the primary study: 2 deep intramuscular injections (Months 0, \& 6)

placebo

Intervention Type BIOLOGICAL

In the primary study: 1 deep intramuscular injection (month 1)

3-Dose Engerix

subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.

Group Type ACTIVE_COMPARATOR

10 μg Engerix™-B (preservative-free)

Intervention Type BIOLOGICAL

In the primary study: 3 deep intramuscular injections (months 0, 1 \& 6)

Interventions

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Engerix™-B (thiomersal-free) 20µg

In the primary study: 2 deep intramuscular injections (Months 0, \& 6)

Intervention Type BIOLOGICAL

10 μg Engerix™-B (preservative-free)

In the primary study: 3 deep intramuscular injections (months 0, 1 \& 6)

Intervention Type BIOLOGICAL

placebo

In the primary study: 1 deep intramuscular injection (month 1)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects have participated in primary study HBV-280
* Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood-sampling visit of each year

Minimum Eligible Age

13 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Sydney, New South Wales, Australia

Site Status

GSK Investigational Site

Brussels, , Belgium

Site Status

GSK Investigational Site

Wilrijk, , Belgium

Site Status

GSK Investigational Site

Kyiv, , Ukraine

Site Status

Countries

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Australia Belgium Ukraine

References

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Heron L, Selnikova O, Moiseieva A, Van Damme P, van der Wielen M, Levie K, Hoet B, Stoffel M. Immunogenicity, reactogenicity and safety of two-dose versus three-dose (standard care) hepatitis B immunisation of healthy adolescents aged 11-15 years: a randomised controlled trial. Vaccine. 2007 Apr 12;25(15):2817-22. doi: 10.1016/j.vaccine.2006.12.021. Epub 2006 Dec 29.

Reference Type BACKGROUND

PMID: 17276552 (View on PubMed)

Heron LG, Chant KG, Jalaludin BB. A novel hepatitis B vaccination regimen for adolescents: two doses 12 months apart. Vaccine. 2002 Oct 4;20(29-30):3472-6. doi: 10.1016/s0264-410x(02)00346-8.

Reference Type BACKGROUND

PMID: 12297392 (View on PubMed)

Van Damme P, Moiseeva A, Marichev I, Kervyn AD, Booy R, Kuriyakose S, Brockway A, Ng SP, Leyssen M, Jacquet JM. Five years follow-up following two or three doses of a hepatitis B vaccine in adolescents aged 11-15 years: a randomised controlled study. BMC Infect Dis. 2010 Dec 20;10:357. doi: 10.1186/1471-2334-10-357.

Reference Type BACKGROUND

PMID: 21171982 (View on PubMed)

Study Documents

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Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 101695 (Ext HBV-280 M30) are summarised with studies 103860/280 (HBV-280), 101696 (Ext HBV-280 M42), 101697 (Ext HBV-280 M54) and 101698

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