Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.
Multicentre Immune Memory Study in Healthy Children Following a 3 Dose Primary Vaccination With Prevenar or GSK Biologicals' Pneumococcal Conjugate Vaccine Via the Administration of a Single Booster Dose of Pneumovax 23
1 other identifier
interventional
120
1 country
30
Brief Summary
To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2006
Shorter than P25 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2006
CompletedFirst Posted
Study publicly available on registry
June 5, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedOctober 7, 2016
October 1, 2016
June 2, 2006
October 6, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Antibody concentrations against pneumococcal serotypes 1 month post-booster
Secondary Outcomes (1)
Immunogenicity pre and post-booster and safety (follow up of SAEs)
Interventions
Eligibility Criteria
You may qualify if:
- healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (30)
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167, Germany
GSK Investigational Site
Marbach, Baden-Wurttemberg, 71672, Germany
GSK Investigational Site
Nördlingen, Bavaria, 86720, Germany
GSK Investigational Site
Tutzing, Bavaria, 82327, Germany
GSK Investigational Site
Wiesbaden, Hesse, 65205, Germany
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18146, Germany
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, 17192, Germany
GSK Investigational Site
Bad Oeynhausen, North Rhine-Westphalia, 32549, Germany
GSK Investigational Site
Erkrath, North Rhine-Westphalia, 40699, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574, Germany
GSK Investigational Site
Heiligenhaus, North Rhine-Westphalia, 42579, Germany
GSK Investigational Site
Minden, North Rhine-Westphalia, 32427, Germany
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41061, Germany
GSK Investigational Site
Mönchengladbach, North Rhine-Westphalia, 41236, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, 48159, Germany
GSK Investigational Site
Oberhausen, North Rhine-Westphalia, 46145, Germany
GSK Investigational Site
Willich, North Rhine-Westphalia, 47877, Germany
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55131, Germany
GSK Investigational Site
Trier, Rhineland-Palatinate, 54294, Germany
GSK Investigational Site
Leipzig, Saxony, 04178, Germany
GSK Investigational Site
Stollberg, Saxony, 09366, Germany
GSK Investigational Site
Berlin, State of Berlin, 10315, Germany
GSK Investigational Site
Berlin, State of Berlin, 12627, Germany
GSK Investigational Site
Berlin, State of Berlin, 12679, Germany
GSK Investigational Site
Berlin, State of Berlin, 13055, Germany
GSK Investigational Site
Berlin, State of Berlin, 14197, Germany
GSK Investigational Site
Bad Lobenstein, Thuringia, 07356, Germany
GSK Investigational Site
Neuhaus am Rennweg, Thuringia, 98724, Germany
GSK Investigational Site
Weimar, Thuringia, 99425, Germany
Related Publications (1)
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.
PMID: 21909049BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2006
First Posted
June 5, 2006
Study Start
August 1, 2006
Study Completion
December 1, 2006
Last Updated
October 7, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.