Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-27

Study Completion Date

2006-04-07

Brief Summary

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Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age

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Detailed Description

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Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib

Conditions

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Infections, Streptococcal Streptococcus Pneumoniae Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Pneumococcal (vaccine)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or female between, and including, 8 and 16 weeks (56-118 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 study period.
* Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.

Minimum Eligible Age

8 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

Mannheim, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Marbach, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Nördlingen, Bavaria, Germany

Site Status

GSK Investigational Site

Tutzing, Bavaria, Germany

Site Status

GSK Investigational Site

Wiesbaden, Hesse, Germany

Site Status

GSK Investigational Site

Rostock, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Waren, Mecklenburg-Vorpommern, Germany

Site Status

GSK Investigational Site

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Erkrath, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Minden, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Mönchengladbach, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Mönchengladbach, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Münster, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Oberhausen, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Willich, North Rhine-Westphalia, Germany

Site Status

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Gerolstein, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Trier, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Leipzig, Saxony, Germany

Site Status

GSK Investigational Site

Stollberg, Saxony, Germany

Site Status

GSK Investigational Site

Bad Lobenstein, Thuringia, Germany

Site Status

GSK Investigational Site

Neuhaus am Rennweg, Thuringia, Germany

Site Status

GSK Investigational Site

Weimar, Thuringia, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

Countries

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Germany

References

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Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Kollges R, Fanic A, Habib A, Borys D, Dieussaert I, Schuerman L. Induction of immunologic memory following primary vaccination with the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine in infants. Pediatr Infect Dis J. 2012 Jan;31(1):e31-6. doi: 10.1097/INF.0b013e3182323ac2.

Reference Type BACKGROUND

PMID: 21909049 (View on PubMed)

Study Documents

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