Last updated: 11/03/2018 09:06:09
Immune memory evaluation in children following a primary vaccination with pneumococcal conjugate vaccines.
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: To evaluate the immunological memory against pneumococcal vaccine serotypes in children primed with conjugate vaccines by administering a booster dose of plain polysaccharide vaccine.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Pneumococcal vaccine
Enrollment:
120
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical 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. 31(1):e31-e36
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
August 2006 to December 2006
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
11 - 14 months
Accepts healthy volunteers
Yes
- Inclusion:
- healthy children between 11-14 months old who received primary vaccination with Prevnar or GSK Biologicals' pneumococcal conjugate vaccine.
Inclusion and exclusion criteria
Inclusion 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.
Trial location(s)
Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68167
Status
Study Complete
Location
GSK Investigational Site
Bad Oeynhausen, Nordrhein-Westfalen, Germany, 32549
Status
Study Complete
Location
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41061
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Minden, Nordrhein-Westfalen, Germany, 32427
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54294
Status
Study Complete
Location
GSK Investigational Site
Willich, Nordrhein-Westfalen, Germany, 47877
Status
Study Complete
Location
GSK Investigational Site
Erkrath, Nordrhein-Westfalen, Germany, 40699
Status
Study Complete
Location
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41236
Status
Study Complete
Location
GSK Investigational Site
Oberhausen, Nordrhein-Westfalen, Germany, 46145
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, Germany, 17192
Status
Study Complete
Location
GSK Investigational Site
Neuhaus am Rennweg, Thueringen, Germany, 98724
Status
Study Complete
Location
GSK Investigational Site
Marbach, Baden-Wuerttemberg, Germany, 71672
Status
Study Complete
Location
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
Status
Study Complete
Location
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
Status
Study Complete
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48159
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18146
Status
Terminated/Withdrawn
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2006-08-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Primary Study
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