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LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers

NCT ID: NCT00240526

Last Updated: 2016-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2010-03-31

Brief Summary

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To evaluate the persistence of anti-HBs antibodies up to 16, 17, 18, 19 and 20 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.

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

Detailed Description

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The primary study was to evaluate the reactogenicity, immunogenicity and protective efficacy of a hepatitis B vaccine in healthy neonates of HBeAg positive mothers if administered with or without a dose of HBIg at birth. The current study describes the long term follow up of these subjects between Y16 and 20 after primary vaccination.

Conditions

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Hepatitis B

Keywords

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Hepatitis B immunoglobulin Hepatitis B antibody persistence

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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Engerix 4D + HBIg Group

Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.

Group Type EXPERIMENTAL

Engerix™ -B

Intervention Type BIOLOGICAL

3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study

Hepatitis B immunoglobulin (HBIg)

Intervention Type BIOLOGICAL

1 intramuscular injections at birth (primary study)

Engerix 3D + HBIg Group

Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.

Group Type EXPERIMENTAL

Engerix™ -B

Intervention Type BIOLOGICAL

3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study

Hepatitis B immunoglobulin (HBIg)

Intervention Type BIOLOGICAL

1 intramuscular injections at birth (primary study)

Engerix 4D

Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, 6 and 60.

Group Type EXPERIMENTAL

Engerix™ -B

Intervention Type BIOLOGICAL

3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study

Engerix 3D Group

Subjects received Engerix™ (hepatitis B vaccine \[HBV\]) at Month 0, 1, and 6.

Group Type EXPERIMENTAL

Engerix™ -B

Intervention Type BIOLOGICAL

3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study

Interventions

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Engerix™ -B

3 (Groups A and C) or 4 (Groups B and D) intramuscular injections during the primary study

Intervention Type BIOLOGICAL

Hepatitis B immunoglobulin (HBIg)

1 intramuscular injections at birth (primary study)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subjects who had received at least one dose of the study vaccine in the primary study
* Written informed consent obtained from each subject before each blood sampling visit

Exclusion Criteria

* None
Minimum Eligible Age

16 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

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

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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Poovorawan Y, Chongsrisawat V, Theamboonlers A, Leroux-Roels G, Crasta PD, Hardt K. Persistence and immune memory to hepatitis B vaccine 20 years after primary vaccination of Thai infants, born to HBsAg and HBeAg positive mothers. Hum Vaccin Immunother. 2012 Jul;8(7):896-904. doi: 10.4161/hv.19989. Epub 2012 Jul 1.

Reference Type DERIVED
PMID: 22777097 (View on PubMed)

Study Documents

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Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Dataset Specification

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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100450

Identifier Type: -

Identifier Source: org_study_id