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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

March 7, 2006
September 22, 2016
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
Not Provided
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
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
Infections, Streptococcal
Biological: 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
April 2006
Not Provided

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.
Sexes Eligible for Study: All
8 Weeks to 16 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
United States
 
NCT00307541
105554
Not Provided
Not Provided
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

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