Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.

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

2006-08-31

Study Completion Date

2006-12-31

Brief Summary

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To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.

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Detailed Description

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2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.

Conditions

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Infections, Streptococcal

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

* healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.

Exclusion:

* children having received or planning to receive any investigational products, vaccines not foreseen in the protocol and immune modifying drugs;
* children having received any additional pneumococcal vaccine than in the primary study;
* children with any disease that affect the immune system and history of seizures and/or allergic disease.

Minimum Eligible Age

11 Months

Maximum Eligible Age

14 Months

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

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

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

GSK Investigational Site

Berlin, State of Berlin, Germany

Site Status

GSK Investigational Site

Berlin, State of Berlin, 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

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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