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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00307541
First received: March 7, 2006
Last updated: September 21, 2011
Last verified: September 2011
  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
Pneumococcal Disease
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

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
Intervention Details:
    Biological: Pneumococcal (vaccine)
    Other Name: Pneumococcal (vaccine)
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
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, 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
Minden, Nordrhein-Westfalen, Germany, 32427
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41236
GSK Investigational Site
Moenchengladbach, Nordrhein-Westfalen, Germany, 41061
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, 10315
GSK Investigational Site
Berlin, Germany, 13055
GSK Investigational Site
Berlin, Germany, 13409
GSK Investigational Site
Berlin, Germany, 12627
GSK Investigational Site
Berlin, Germany, 14197
GSK Investigational Site
Berlin, Germany, 14109
GSK Investigational Site
Berlin, Germany, 12679
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
No publications provided by GlaxoSmithKline

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: NCT00307541     History of Changes
Other Study ID Numbers: 105554
Study First Received: March 7, 2006
Last Updated: September 21, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on July 22, 2014