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NCT00334334

Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine.

Last Updated: 2016-11-04

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

PHASE3

Total Enrollment

1572 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-08-31

Brief Summary

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Three dose primary vaccination of healthy infants between 6 to 16 weeks of age at the time of the first vaccination against Streptococcus pneumonia, Neisseria meningitidis and Haemophilus influenzae type b.

Detailed Description

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Conditions

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Infections, Streptococcal

Keywords

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Streptococcus pneumonia, vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Pneumococcal (vaccine)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* male or female between, and including, 6-16 weeks (42 to 118 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.

Exclusion Criteria

* use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period.
* Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before each dose of vaccine(s) and ending 7 days after dose 1 and dose 2 or 1 month after dose 3.
* Previous vaccinations against diseases which are targeted by the vaccines used in the study.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

16 Weeks

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

Bad Saulgau, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany

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GSK Investigational Site

Bretten, Baden-Wurttemberg, Germany

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GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

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GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, Germany

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GSK Investigational Site

Kehl, Baden-Wurttemberg, Germany

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GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

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GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

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GSK Investigational Site

Oberstenfeld, Baden-Wurttemberg, Germany

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GSK Investigational Site

Schwäbisch Hall, Baden-Wurttemberg, Germany

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GSK Investigational Site

Stuttgart, Baden-Wurttemberg, Germany

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GSK Investigational Site

Tettnang, Baden-Wurttemberg, Germany

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GSK Investigational Site

Cham, Bavaria, Germany

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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

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GSK Investigational Site

Olching, Bavaria, Germany

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GSK Investigational Site

Roding, Bavaria, Germany

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GSK Investigational Site

Eschwege, Hesse, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, Germany

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GSK Investigational Site

Niedernhausen, Hesse, Germany

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GSK Investigational Site

Wolfenbüttel, Lower Saxony, Germany

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GSK Investigational Site

Herford, North Rhine-Westphalia, Germany

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GSK Investigational Site

Hille, North Rhine-Westphalia, Germany

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GSK Investigational Site

Löhne, North Rhine-Westphalia, Germany

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GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

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GSK Investigational Site

Porta Westfalica, North Rhine-Westphalia, Germany

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GSK Investigational Site

Bad Kreuznach, Rhineland-Palatinate, Germany

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GSK Investigational Site

Bodenheim, Rhineland-Palatinate, Germany

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GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

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GSK Investigational Site

Gerolstein, Rhineland-Palatinate, Germany

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GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

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GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

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GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

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GSK Investigational Site

Worms, Rhineland-Palatinate, Germany

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GSK Investigational Site

Döbeln, Saxony, Germany

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