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

March 7, 2006
September 21, 2011
October 2005
Not Provided
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
Same as current
Complete list of historical versions of study NCT00307541 on ClinicalTrials.gov Archive Site
  • 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)
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 vaccinatio
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Not Provided
 
Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
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

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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Pneumococcal Disease
Biological: Pneumococcal (vaccine)
Other Name: Pneumococcal (vaccine)
Not Provided
Knuf M, Pankow-Culot H, Grunert D, Rapp M, Panzer F, Köllges R, Fanic A, Habib A, Borys D, Dieussaert I, Schuerman L. 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. 2012 Jan;31(1):e31-6. doi: 10.1097/INF.0b013e3182323ac2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
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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.
Both
8 Weeks to 16 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00307541
105554
Not Provided
Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP