Immune Memory Evaluation in Children Following a Primary Vaccination With Pneumococcal Conjugate Vaccines.
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00333450
First received: June 2, 2006
Last updated: March 1, 2012
Last verified: February 2012
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Purpose
To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.
| Condition | Intervention | Phase |
|---|---|---|
|
Prophylaxis Pneumococcal Vaccine |
Biological: Pneumococcal vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Antibody concentrations against pneumococcal serotypes 1 month post-booster
Secondary Outcome Measures:
- Immunogenicity pre and post-booster and safety (follow up of SAEs)
| Estimated Enrollment: | 120 |
| Study Start Date: | August 2006 |
Intervention Details:
Detailed Description:
-
Biological: Pneumococcal vaccine
Other Name: Pneumococcal vaccine
2 groups (60 per group), booster of Pneumovax 23 after priming with Prevnar or GSK Biologicals' pneumococcal vaccine.
Eligibility| Ages Eligible for Study: | 11 Months to 14 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00333450
Locations
| Germany | |
| GSK Investigational Site | |
| Mannheim, Baden-Wuerttemberg, Germany, 68167 | |
| GSK Investigational Site | |
| Marbach, Baden-Wuerttemberg, Germany, 71672 | |
| GSK Investigational Site | |
| Noerdlingen, Bayern, Germany, 86720 | |
| GSK Investigational Site | |
| Tutzing, Bayern, Germany, 82327 | |
| GSK Investigational Site | |
| Wiesbaden, Hessen, Germany, 65205 | |
| GSK Investigational Site | |
| Waren, Mecklenburg-Vorpommern, Germany, 17192 | |
| GSK Investigational Site | |
| Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549 | |
| GSK Investigational Site | |
| Erkrath, Nordrhein-Westfalen, Germany, 40699 | |
| GSK Investigational Site | |
| Goch, Nordrhein-Westfalen, Germany, 47574 | |
| GSK Investigational Site | |
| Heiligenhaus, Nordrhein-Westfalen, Germany, 42579 | |
| GSK Investigational Site | |
| Minden, Nordrhein-Westfalen, Germany, 32427 | |
| GSK Investigational Site | |
| Moenchengladbach, Nordrhein-Westfalen, Germany, 41061 | |
| GSK Investigational Site | |
| Moenchengladbach, Nordrhein-Westfalen, Germany, 41236 | |
| GSK Investigational Site | |
| Muenster, Nordrhein-Westfalen, Germany, 48159 | |
| GSK Investigational Site | |
| Oberhausen, Nordrhein-Westfalen, Germany, 46145 | |
| GSK Investigational Site | |
| Willich, Nordrhein-Westfalen, Germany, 47877 | |
| GSK Investigational Site | |
| Frankenthal, Rheinland-Pfalz, Germany, 67227 | |
| GSK Investigational Site | |
| Mainz, Rheinland-Pfalz, Germany, 55131 | |
| GSK Investigational Site | |
| Trier, Rheinland-Pfalz, Germany, 54294 | |
| GSK Investigational Site | |
| Leipzig, Sachsen, Germany, 04178 | |
| GSK Investigational Site | |
| Stollberg, Sachsen, Germany, 09366 | |
| GSK Investigational Site | |
| Lobenstein, Thueringen, Germany, 07356 | |
| GSK Investigational Site | |
| Neuhaus am Rennweg, Thueringen, Germany, 98724 | |
| GSK Investigational Site | |
| Weimar, Thueringen, Germany, 99425 | |
| GSK Investigational Site | |
| Berlin, Germany, 12679 | |
| GSK Investigational Site | |
| Berlin, Germany, 13055 | |
| GSK Investigational Site | |
| Berlin, Germany, 14197 | |
| GSK Investigational Site | |
| Berlin, Germany, 10315 | |
| GSK Investigational Site | |
| Berlin, Germany, 12627 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Additional Information:
Publications:
Knuf M et al. (2011) 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. [Epub ahead of print].
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure |
| ClinicalTrials.gov Identifier: | NCT00333450 History of Changes |
| Other Study ID Numbers: | 106623 |
| Study First Received: | June 2, 2006 |
| Last Updated: | March 1, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
ClinicalTrials.gov processed this record on May 23, 2013