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Clinical Trial Summary

The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age. Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™. This protocol posting deals with objectives & outcome measures of the extension phase at year 4. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives & outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT00907777
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date June 23, 2009
Completion date October 5, 2009

See also
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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Withdrawn NCT01160055 - Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children N/A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Withdrawn NCT01031329 - Study to Identify and Characterize Bacteria Causing Acute Otitis Media in Young Children in Turkey N/A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