Last updated: 11/03/2018 00:12:20
A study in children with different formulations of GSK Biologicals' 11 valent pneumococcal conjugate vaccine
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A randomized, controlled, phase II study to evaluate the safety and immunogenicity of different formulations of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3-dose primary immunization (2-3-4 month schedule) before 6 months of age
Trial description: Three dose primary vaccination with 11-valent pneumococcal conjugate vaccine administered concomitantly with Infanrix™ hexa to healthy infants between 8 to 16 weeks of age at the time of first vaccination.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:
1 month after d3, antibody concentrations to pneumo. serotypes 1,3,4,5,6B,7F,9V,14,18C,19Fand23F.Occurrence of: solicited local and general symptoms within 8 days after each vaccination; unsolicited adverse events within 31 days after each vaccination
Timeframe: 1 Month after dose 3
Secondary outcomes:
1 month post d3: For pneumo.serotypes 1,3,4,5,6B,7F, 9V,14,18C,19F,23F:Opsono titres;antibody concentrations (AbC) >= 0.20 µg/mL;AbC to protein D and seropositivity (S+)status; S+/seroprotection status to antigens in Infanrix hexa.
Timeframe: 1 Month after dose 3
Interventions:
Enrollment:
689
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Streptococcal Infections
Product
GSK429353A
Collaborators
Not applicable
Study date(s)
October 2004 to May 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
8 - 16 weeks
Accepts healthy volunteers
Yes
- Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject.
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period.
- Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female aged 8-16 weeks at the time of first vaccination, written informed consent obtained from the parent/guardian of subject.
Exclusion criteria:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period.
- Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.
Trial location(s)
Location
GSK Investigational Site
Kleve-Materborn, Nordrhein-Westfalen, Germany, 47533
Status
Study Complete
Location
GSK Investigational Site
Bredstedt, Schleswig-Holstein, Germany, 25821
Status
Study Complete
Location
GSK Investigational Site
Loehne, Nordrhein-Westfalen, Germany, 32584
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24937
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24944
Status
Study Complete
Location
GSK Investigational Site
Herzogenaurach, Bayern, Germany, 91074
Status
Study Complete
Location
GSK Investigational Site
Dortmund, Nordrhein-Westfalen, Germany, 44329
Status
Study Complete
Location
GSK Investigational Site
Schwaebisch-Hall, Baden-Wuerttemberg, Germany, 74523
Status
Study Complete
Location
GSK Investigational Site
Husum, Schleswig-Holstein, Germany, 25813
Status
Study Complete
Location
GSK Investigational Site
Frankenthal, Rheinland-Pfalz, Germany, 67227
Status
Study Complete
Location
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
Status
Study Complete
Location
GSK Investigational Site
Waren, Mecklenburg-Vorpommern, Germany, 17192
Status
Study Complete
Location
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
Status
Study Complete
Location
GSK Investigational Site
Krefeld, Nordrhein-Westfalen, Germany, 47798
Status
Study Complete
Location
GSK Investigational Site
Schoeneberg - Kuebelberg, Rheinland-Pfalz, Germany, 66901
Status
Study Complete
Location
GSK Investigational Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Status
Study Complete
Location
GSK Investigational Site
Bodenheim, Rheinland-Pfalz, Germany, 55294
Status
Study Complete
Location
GSK Investigational Site
Bad Saulgau, Baden-Wuerttemberg, Germany, 88348
Status
Study Complete
Location
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18059
Status
Study Complete
Location
GSK Investigational Site
Worms, Rheinland-Pfalz, Germany, 67547
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
Muenster, Nordrhein-Westfalen, Germany, 48159
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24939
Status
Study Complete
Location
GSK Investigational Site
Ludwigshafen, Rheinland-Pfalz, Germany, 67059
Status
Study Complete
Location
GSK Investigational Site
Stuttgart, Baden-Wuerttemberg, Germany, 70469
Status
Study Complete
Location
GSK Investigational Site
Kehl, Baden-Wuerttemberg, Germany, 77694
Status
Study Complete
Location
GSK Investigational Site
Salzgitter, Niedersachsen, Germany, 38226
Status
Study Complete
Location
GSK Investigational Site
Flensburg, Schleswig-Holstein, Germany, 24943
Status
Study Complete
Location
GSK Investigational Site
Tauberbischofsheim, Baden-Wuerttemberg, Germany, 97941
Status
Study Complete
Location
GSK Investigational Site
Detmold, Nordrhein-Westfalen, Germany, 32756
Status
Study Complete
Location
GSK Investigational Site
Oberkirch, Baden-Wuerttemberg, Germany, 77704
Status
Study Complete
Location
GSK Investigational Site
Heiligenhaus, Nordrhein-Westfalen, Germany, 42579
Status
Study Complete
Location
GSK Investigational Site
Eppelheim, Baden-Wuerttemberg, Germany, 69214
Status
Study Complete
Location
GSK Investigational Site
Bretten, Baden-Wuerttemberg, Germany, 75015
Status
Study Complete
Location
GSK Investigational Site
Neumuenster, Schleswig-Holstein, Germany, 24534
Status
Study Complete
Location
GSK Investigational Site
Erkrath, Nordrhein-Westfalen, Germany, 40699
Status
Study Complete
Location
GSK Investigational Site
Lobenstein, Thueringen, Germany, 07356
Status
Study Complete
Location
GSK Investigational Site
Offenburg, Baden-Wuerttemberg, Germany, 77654
Status
Study Complete
Location
GSK Investigational Site
Ettenheim, Baden-Wuerttemberg, Germany, 77955
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
2005-30-05
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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