Clinical Trials Logo

Clinical Trial Summary

This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 (NCT00307554). The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenar™.

The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT00370396
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date September 25, 2006
Completion date November 6, 2007

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 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
Completed NCT01545375 - Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children Phase 2