Last updated: 11/07/2018 01:13:59
Multicentre booster & immune memory study of a booster dose of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or a single dose of 23-valent plain polysaccharide vaccine in healthy children aged 11-18 mths, previously vaccinated in study 103488
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A phase II, multicentre booster study to evaluate booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or to evaluate the immune memory following the administration of a single dose of 23-valent plain polysaccharide vaccine in healthy children, previously vaccinated in infancy in the primary study 11PN-PD-DIT-002 (103488)
Trial description: Booster and immune memory study
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
689
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Silfverdal SA et al. (2016) Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. [Epub ahead of print]
Medical condition
acellular pertussis, Tetanus, Hepatitis B, Diphtheria, Haemophilus influenzae type b, Poliomyelitis
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
November 2005 to March 2006
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
11 - 18 months
Accepts healthy volunteers
Yes
- Male or female between, and including, 11-18 months of age at the time of vaccination and who previously participated in the study 11PN-PD-DIT-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject.
- 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 vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and during the entire study period. Administration of any additional pneumococcal vaccine or DTPa combined vaccine since study end of 11PN-PD-DIT-002 study
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female between, and including, 11-18 months of age at the time of vaccination and who previously participated in the study 11PN-PD-DIT-002 and received at least one dose of pneumococcal conjugate vaccine during the primary study, 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 vaccine not foreseen by the study protocol during the period starting one month before the first dose of vaccine(s) and during the entire study period. Administration of any additional pneumococcal vaccine or DTPa combined vaccine since study end of 11PN-PD-DIT-002 study
Trial location(s)
Location
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
Status
Study Complete
Location
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48159
Status
Study Complete
Location
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
Status
Study Complete
Location
GSK Investigational Site
Herzogenaurach, Bayern, Germany, 91074
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
Status
Study Complete
Location
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, Germany, 17192
Status
Study Complete
Location
GSK Investigational Site
Erkrath, Nordrhein-Westfalen, Germany, 40699
Status
Study Complete
Location
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Bretten, Baden-Wuerttemberg, Germany, 75015
Status
Study Complete
Location
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
Status
Study Complete
Location
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
Status
Study Complete
Location
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24944
Status
Study Complete
Location
GSK Investigational Site
Oberkirch, Baden-Wuerttemberg, Germany, 77704
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24939
Status
Study Complete
Location
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
Status
Study Complete
Location
GSK Investigational Site
Neumuenster, Schleswig-Holstein, Germany, 24534
Status
Study Complete
Location
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
Status
Study Complete
Location
GSK Investigational Site
Eppelheim, Baden-Wuerttemberg, Germany, 69214
Status
Study Complete
Location
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
Status
Study Complete
Location
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
Status
Study Complete
Location
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
Status
Study Complete
Location
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Location
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67059
Status
Study Complete
Location
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44329
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54294
Status
Study Complete
Location
GSK Investigational Site
Wolfenbuettel, Niedersachsen, Germany, 38302
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
Status
Study Complete
Location
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Bodenheim, Rheinland-Pfalz, Germany, 55294
Status
Study Complete
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2006-13-03
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.
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