Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants with the pneumococcal study vaccines.


Clinical Trial Description

The purpose of this study is to assess the immunogenicity of the two formulations of GSK Biologicals' pneumococcal vaccine 2830929A (11-valent vaccine or 11Pn vaccine) and 2830930A (12-valent vaccine or 12Pn vaccine), when administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life, when compared to immune responses to the licensed vaccines Synflorix™ and Prevnar 13™, and to assess the reactogenicity and safety of these two same investigational formulations when administered according to this schedule. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine will be co-administered in infants with the pneumococcal study vaccines. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01616459
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 2
Start date July 11, 2012
Completion date January 22, 2014

See also
  Status Clinical Trial Phase
Completed NCT01641133 - Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™ Phase 3
Completed NCT01204658 - Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants Phase 2
Completed NCT00370396 - Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine. Phase 3
Completed NCT02838407 - Identification and Characterization of Bacteria in the Lungs of Children From 6 Months up to 6 Years Old, With Suspected Infection of the Lungs, in Spain. N/A
Completed NCT00523770 - Exploratory Study in Healthy Elderly Subjects to Collect Urine for Development of Assays to Detect S. Pneumoniae N/A
Completed NCT00756067 - Evaluation of Pneumococcal Vaccine Formulations in Elderly Phase 1
Completed NCT00345358 - Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' 10-valent Pneumococcal Conjugate Vaccine Phase 3
Completed NCT01153893 - Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria Phase 3
Completed NCT00307541 - Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine Phase 3
Completed NCT00547248 - Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines Phase 3
Withdrawn NCT01160055 - Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children N/A
Completed NCT00370227 - Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine Phase 3
Completed NCT00390910 - Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants Phase 3
Completed NCT00985751 - Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination Phase 2
Withdrawn NCT01031329 - Study to Identify and Characterize Bacteria Causing Acute Otitis Media in Young Children in Turkey N/A
Completed NCT00307554 - A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study Phase 3
Completed NCT02270944 - Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine Phase 2
Completed NCT01235949 - Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment Phase 4
Completed NCT00985465 - Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali Phase 3
Completed NCT00861380 - Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease Phase 3