A Study in Children With Different Formulations of GSK Biologicals' 11 Valent Pneumococcal Conjugate Vaccine

NCT ID: NCT00169481

Last Updated: 2017-01-10

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

PHASE2

Total Enrollment

689 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-05-31

Brief Summary

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Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.

Detailed Description

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Test groups: 9 groups receiving different formulations of 11PN-PD-DiT vaccine + DTPa-HBV-IPV/Hib (Infanrix™ hexa) Comparator: 11Pn-PD + Infanrix™ hexa Control: Prevenar® + Infanrix™ hexa

Conditions

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Streptococcal Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Interventions

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Pneumococcal (vaccine)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject.

Exclusion Criteria

* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period.
* Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.
Minimum Eligible Age

8 Weeks

Maximum Eligible Age

16 Weeks

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

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Bretten, Baden-Wurttemberg, Germany

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Eppelheim, Baden-Wurttemberg, Germany

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Ettenheim, Baden-Wurttemberg, Germany

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Kehl, Baden-Wurttemberg, Germany

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Oberkirch, Baden-Wurttemberg, Germany

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Offenburg, Baden-Wurttemberg, Germany

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Schwäbisch Hall, Baden-Wurttemberg, Germany

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Stuttgart, Baden-Wurttemberg, Germany

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Tauberbischofsheim, Baden-Wurttemberg, Germany

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Cham, Bavaria, Germany

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Herzogenaurach, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Munich, Bavaria, Germany

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Nördlingen, Bavaria, Germany

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Olching, Bavaria, Germany

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Weilheim, Bavaria, Germany

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Zwiesel, Bavaria, Germany

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Hamburg, City state of Hamburg, Germany

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Koenigstein, Hesse, Germany

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Marburg/Lahn, Hesse, Germany

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Wiesbaden, Hesse, Germany

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Salzgitter, Lower Saxony, Germany

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Wolfenbüttel, Lower Saxony, Germany

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Rostock, Mecklenburg-Vorpommern, Germany

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Waren, Mecklenburg-Vorpommern, Germany

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Bochum, North Rhine-Westphalia, Germany

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Detmold, North Rhine-Westphalia, Germany

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Dortmund, North Rhine-Westphalia, Germany

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Erkrath, North Rhine-Westphalia, Germany

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Heiligenhaus, North Rhine-Westphalia, Germany

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Kleve-Materborn, North Rhine-Westphalia, Germany

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Krefeld, North Rhine-Westphalia, Germany

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Löhne, North Rhine-Westphalia, Germany

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Münster, North Rhine-Westphalia, Germany

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Bodenheim, Rhineland-Palatinate, Germany

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Frankenthal, Rhineland-Palatinate, Germany

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Ludwigshafen am Rhein, Rhineland-Palatinate, Germany

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Mainz, Rhineland-Palatinate, Germany

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Schoeneberg - Kuebelberg, Rhineland-Palatinate, Germany

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Trier, Rhineland-Palatinate, Germany

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Trier, Rhineland-Palatinate, Germany

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Worms, Rhineland-Palatinate, Germany

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Bredstedt, Schleswig-Holstein, Germany

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Flensburg, Schleswig-Holstein, Germany

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Flensburg, Schleswig-Holstein, Germany

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Flensburg, Schleswig-Holstein, Germany

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Flensburg, Schleswig-Holstein, Germany

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Husum, Schleswig-Holstein, Germany

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Neumünster, Schleswig-Holstein, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Bad Lobenstein, Thuringia, Germany

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GSK Investigational Site

Weimar, Thuringia, Germany

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Countries

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Germany

Study Documents

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Document Type: Study Protocol

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: 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: Individual Participant Data Set

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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103488

Identifier Type: -

Identifier Source: org_study_id

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