TT:14
Sponsors
GlaxoSmithKline Biologicals
Conditions
A 2-4-11 month vaccination schedule of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, co-administered with DTPa combined vaccines in healthy infants between 8-16 weeks of age at the time of first vaccination.Booster vaccination against Streptococcus pneumoniae in healthy children having previously received vaccines as a primary 3-dose vaccination course in the study 11PN-PD-DIT-002.Three dose primary vaccination of healthy infants between 6 and 12 weeks of age at the time of the first vaccination against Streptococcus pneumaniaeThree dose vaccination of healthy infants between 8-16 weeks of age at the time of the first vaccination against Streptococcus pneumoniae.
Unknown Phase
A phase II, multicentre booster study to evaluate booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or to evaluate the immune memory following the administration of a single dose of 23-valent plain polysaccharide vaccine in healthy children, previously vaccinated in infancy in the primary study 11PN-PD-DIT-002 (103488). - 10PN-PD-DIT-004
Active, not recruitingEUCTR2005-003052-36-DE
Start: 2005-11-18Target: 689Updated: 2012-03-19
A 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. - 10PN-PD-DIT-003
Active, not recruitingEUCTR2005-003299-40-DE
Start: 2005-10-18Target: 120Updated: 2012-03-19
A phase III randomised, controlled study to assess in a double blind manner the lot-to-lot consistency of three consecutive production lots of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine and to evaluate the non-inferiority to Prevenar™ in a single blind design, when administered as a 3-dose primary immunization course before 6 months of age. - 10PN-PD-DIT-001
Active, not recruitingEUCTR2005-003300-11-FI
Start: 2005-11-25Target: 1600Updated: 2012-03-19
An open, randomized, phase IIIa study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 10-valent pneumococcal conjugate vaccine, when administered intramuscularly according to a 2-4-11 months vaccination schedule. - 10PN-PD-DIT-002
Active, not recruitingEUCTR2005-003437-41-SE
Start: 2005-11-25Target: 300Updated: 2012-03-19