PS-TT for serotype 18C

5 trials

Sponsors

GlaxoSmithKline Biologicals

Conditions

A single dose of either 10Pn-PD-DiT or Prevenar vaccine to healthy children previously primed with 3 primary doses of 10Pn-PD-DiT or Prevenar vaccine in study 10PN-PD-DIT-003 (105554) and a booster dose of Pneumovax 23 (23vPS) vaccine in study 10PN-PD-DIT-008 BST: 003 (106623).Active immunization of children from the age of 6 weeks up to 18 months of age at the time of first vaccination, against Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and Haemophilus influenzae. The immunization schedule will depend on the age at the time of the first vaccination. MedDRA version: 14.0 Level: PT Classification code 10061353 Term: Pneumococcal infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: PT ClassifSubjects aged 31-44 months previously vaccinated with GSK Biologicals’ 10Pn-PD-DiT vaccine and age-matched unprimed children who participated in study 10PN-PD-DIT-014 (107137).Three dose primary vaccination of preterm infants between 8-16 weeks (56-118 days) of age at the time of first vaccination against Streptococcus pneumoniae.

Phase 3

A phase IIIb open study to assess the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals´ 10-valent pneumococcal conjugate vaccine when co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine in preterm infants as a 3-dose primary immunisation course during the first 6 months of life - 10PN-PD-DIT-015

Active, not recruitingEUCTR2006-002898-47-GR

GlaxoSmithKline BiologicalsThree dose primary vaccination of preterm infants between 8-16 weeks (56-118 days) of age at the time of first vaccination against Streptococcus pneumoniae.

Start: 2007-01-16Target: 300Updated: 2022-08-08

Unknown Phase

A phase III/IV, cluster-randomized, controlled study to evaluate the effectiveness of GlaxoSmithKline Biologicals’ 10-valent pneumococcal and non-typeable Haemophilus influenzae protein D conjugate vaccine in reducing the incidence of invasive diseases. - 10PN-PD-DIT-043

Active, not recruitingEUCTR2008-005149-48-FI

GlaxoSmithKline BiologicalsActive immunization of children from the age of 6 weeks up to 18 months of age at the time of first vaccination, against Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and Haemophilus influenzae. The immunization schedule will depend on the age at the time of the first vaccination. MedDRA version: 14.0 Level: PT Classification code 10061353 Term: Pneumococcal infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: PT Classif

Start: 2009-02-10Updated: 2014-01-27

A phase III double-blind, cluster-randomized, controlled study to evaluate the impact on nasopharyngeal carriage, acute otitis media, immunogenicity and safety of GSK Biologicals’ 10-valent pneumococcal and non-typeable Haemophilus influenzae protein D conjugate vaccine in children starting vaccination below 18 months of age. - 10PN-PD-DIT-053

Active, not recruitingEUCTR2008-006551-51-FI

GlaxoSmithKline BiologicalsActive immunization of children from the age of 6 weeks up to 18 months of age at the time of first vaccination, against Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and Haemophilus influenzae. The immunization schedule will depend on the age at the time of the first vaccination. MedDRA version: 14.0 Level: PT Classification code 10061353 Term: Pneumococcal infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: PT Classif

Start: 2009-02-05Updated: 2013-02-11

A phase III, open, multicentre, extension study to assess the immune response following administration of an additional dose of GSK Biologicals’ 10-valent conjugate pneumococcal vaccine or Prevenar™ at approximately 4 years of age in children previously vaccinated with three primary doses of a pneumococcal conjugate vaccine in study 10PN-PD-DIT-003 (105554) and a booster dose of 23-valent pneumococcal plain polysaccharide vaccine in study 10PN-PD-DIT-008 BST: 003 (106623). - 10PN-PD-DIT-061 EXT: 008 Y4

Active, not recruitingEUCTR2008-007605-37-DE

GlaxoSmithKline BiologicalsA single dose of either 10Pn-PD-DiT or Prevenar vaccine to healthy children previously primed with 3 primary doses of 10Pn-PD-DiT or Prevenar vaccine in study 10PN-PD-DIT-003 (105554) and a booster dose of Pneumovax 23 (23vPS) vaccine in study 10PN-PD-DIT-008 BST: 003 (106623).

Start: 2009-05-12Target: 75Updated: 2012-03-19

A phase III long-term follow-up study to assess immunological memory induced following primary and booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine (10Pn-PD-DiT), through evaluation of early antibody responses after an additional dose of 10Pn-PD-DiT at 40-48 months of age, to evaluate in the fourth year of life, the immunogenicity and safety of a 2-dose catch-up immunization course with the 10Pn-PD-DiT vaccine and the impact of pneumococcal vaccination on nasopharyngeal carriage. - 10PN-PD-DIT-042 EXT 014

Active, not recruitingEUCTR2008-008104-41-CZ

GlaxoSmithKline BiologicalsSubjects aged 31-44 months previously vaccinated with GSK Biologicals’ 10Pn-PD-DiT vaccine and age-matched unprimed children who participated in study 10PN-PD-DIT-014 (107137).

Start: 2009-07-03Target: 690Updated: 2012-03-19