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PS-TT for 18C

5 trials

Sponsors

GlaxoSmithKline Biologicals

Conditions

A three-dose primary vaccination of healthy infants between 9-16 weeks (63-118 days) of age at the time of the first vaccination against Streptococcus pneumoniae.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.Booster vaccination against Streptococcus pneumoniae of healthy preterm born children between 16-18 months of age who were previously primed with three doses of GSK Biologicals’10-valent conjugate pneumococcal vaccine co-administered with DTPa-HBV-IPV/Hib in the primary vaccination study 10PN-PD-DIT-015.Three dose vaccination of healthy infants between 8-16 weeks of age at the time of the first vaccination against Streptococcus pneumoniae.Two doses vaccination in adults subjects aged between 18 and 40 years old, in good general health and not previously immunized with the 23-valent pneumococcal polysaccharide vaccine.

Phase 1

An open, phase I/II study to evaluate the safety, reactogenicity and immunogenicity of GSK Biologicals’ 11PCV combined with adjuvant AS02V given as a 2-dose vaccination in adults aged 18-40 years old. - EXPLO-CRD-006
Active, not recruitingEUCTR2006-000442-39-BE
GlaxoSmithKline BiologicalsTwo doses vaccination in adults subjects aged between 18 and 40 years old, in good general health and not previously immunized with the 23-valent pneumococcal polysaccharide vaccine.
Start: 2006-04-12Target: 10Updated: 2022-03-28

Phase 3

A phase IIIb randomized, open, controlled study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant administration of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine with GSK Biologicals’ Infanrix hexa vaccine in children at 3, 4 and 5 months of age and GSK Biologicals’ Rotarix vaccine at 3 and 4 months of age. - 10PN-PD-DIT-010
Active, not recruitingEUCTR2006-000559-16-CZ
GlaxoSmithKline BiologicalsA three-dose primary vaccination of healthy infants between 9-16 weeks (63-118 days) of age at the time of the first vaccination against Streptococcus pneumoniae.
Start: 2006-08-09Target: 460Updated: 2022-04-04

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
GlaxoSmithKline BiologicalsBooster 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.
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
GlaxoSmithKline BiologicalsThree dose vaccination of healthy infants between 8-16 weeks of age at the time of the first vaccination against Streptococcus pneumoniae.
Start: 2005-10-18Target: 120Updated: 2012-03-19
A phase III open study to assess the safety, reactogenicity and immunogenicity following booster administration of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine, co-administered with a booster dose of DTPa-IPV/Hib (Infanrix-IPV/Hib) vaccine in preterm born children at 16-18 months of age following primary immunisation in study 10PN-PD-DIT-015 (107737) - 10PN-PD-DIT-016 BST:015
Active, not recruitingEUCTR2007-000596-42-GR
GlaxoSmithKline BiologicalsBooster vaccination against Streptococcus pneumoniae of healthy preterm born children between 16-18 months of age who were previously primed with three doses of GSK Biologicals’10-valent conjugate pneumococcal vaccine co-administered with DTPa-HBV-IPV/Hib in the primary vaccination study 10PN-PD-DIT-015.
Start: 2007-10-30Target: 300Updated: 2012-03-19