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Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00307541
First received: March 7, 2006
Last updated: September 22, 2016
Last verified: September 2016
  Purpose
Evaluate the immune response of GSK Biologicals' 10-valent pneumococcal conjugate vaccine one month after completion of a 3-dose primary vaccination course administered at 2, 3, 4 months of age

Condition Intervention Phase
Infections, Streptococcal
Biological: Pneumococcal (vaccine)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Official Title: Phase IIIa Randomized, Controlled Study to Assess the Immunogenicity of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine, When Administered as a 3-dose Primary Immunization Course Before 6 Months of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 1 month post-dose 3: Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations >= 0.20 µg/mL

Secondary Outcome Measures:
  • 1 month post dose 3: For all vaccine pneumococcal serotypes: Opsono titres
  • Antibody (Ab) concns >= 0.05 µg/mL
  • Ab concns to protein D and seropositivity (S+) status
  • S+/seroprotection status to antigens in DTPa-HBV-IPV/Hib vaccine
  • After each vaccination, occurrence of: solicited local, general symptoms within 4 days
  • Unsolicited adverse events within 31 days, SAEs (whole study period)

Estimated Enrollment: 120
Study Start Date: October 2005
Study Completion Date: April 2006
Detailed Description:
Test groups: 2 groups (60 subjects/group). 10Pn-PD-DiT group receiving GSK Biologicals' 10-valent pneumococcal conjugate vaccine + DTPa-HBV-IPV/Hib; Control group receiving Prevenar + DTPa-HBV-IPV/Hib
  Eligibility

Ages Eligible for Study:   8 Weeks to 16 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Male or female between, and including, 8 and 16 weeks (56-118 days) of age at the time of the first vaccination, 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 licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307541

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
Rostock, Mecklenburg-Vorpommern, Germany, 18059
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, Germany, 18146
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
Krefeld, Nordrhein-Westfalen, Germany, 47798
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
Gerolstein, Rheinland-Pfalz, Germany, 54568
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54294
GSK Investigational Site
Doebeln, Sachsen, Germany, 04720
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, 10315
GSK Investigational Site
Berlin, Germany, 12627
GSK Investigational Site
Berlin, Germany, 12679
GSK Investigational Site
Berlin, Germany, 13055
GSK Investigational Site
Berlin, Germany, 13409
GSK Investigational Site
Berlin, Germany, 14109
GSK Investigational Site
Berlin, Germany, 14197
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 105554
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 105554
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 105554
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 105554
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 105554
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 105554
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00307541     History of Changes
Other Study ID Numbers: 105554 
Study First Received: March 7, 2006
Last Updated: September 22, 2016
Health Authority: Germany: Paul-Ehrlich-Institut
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 29, 2016