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Persistence of the Immune Response to Hepatitis B in 4-6 Years Old Children Previously Vaccinated With DTPa-HBV-IPV/Hib

NCT ID: NCT00335881

Last Updated: 2016-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2006-11-30

Brief Summary

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Persistence of seroprotective antibody concentrations \& immunological memory shown by the ability to mount a response to a challenge dose of HBV vaccine

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Detailed Description

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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

Interventions

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hepatitis B vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* A male or female aged 4 to 6 years at the time of study entry .
* Subjects who have received a total of 4 doses of DTPa-HBV-IPV/Hib vaccine in previous vaccination studies.
* Evidence of previous hepatitis B booster vaccination or disease since administration of the fourth dose of DTPa-HBV-IPV/Hib vaccine.
Minimum Eligible Age

4 Years

Maximum Eligible Age

6 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

Bad Saulgau, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

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GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

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GSK Investigational Site

Oberkirch, Baden-Wurttemberg, Germany

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GSK Investigational Site

Offenburg, Baden-Wurttemberg, Germany

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GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

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GSK Investigational Site

Tuttlingen, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Cham, Bavaria, Germany

Site Status

GSK Investigational Site

Freising, Bavaria, Germany

Site Status

GSK Investigational Site

Kaufering, Bavaria, Germany

Site Status

GSK Investigational Site

Landsberg am Lech, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

Site Status

GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Nördlingen, Bavaria, Germany

Site Status

GSK Investigational Site

Tutzing, Bavaria, Germany

Site Status

GSK Investigational Site

Weilheim, Bavaria, Germany

Site Status

GSK Investigational Site

Salzgitter, Lower Saxony, Germany

Site Status

GSK Investigational Site

Waren, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Erkrath, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Kleve-Materborn, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Krefeld, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Willich, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Schoeneberg - Kuebelberg, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

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GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Altenholz, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Bredstedt, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Flensburg, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Husum, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

References

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Zinke M, Disselhoff J; DTP a-HBV-IPV-110 and -111 study groups; Gartner B, Jacquet JM. Immunological persistence in 4-6 and 7-9 year olds previously vaccinated in infancy with hexavalent DTPa-HBV-IPV/Hib. Hum Vaccin. 2010 Feb;6(2):189-93. doi: 10.4161/hv.6.2.10117.

Reference Type DERIVED
PMID: 20009522 (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: Individual Participant Data Set

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

View Document

Document Type: Dataset Specification

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: Statistical Analysis Plan

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

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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106745

Identifier Type: -

Identifier Source: org_study_id

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