Infections, Streptococcal Clinical Trial
Official title:
Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Pneumococcal Vaccine (Synflorix™) When Administered to Children Who Are at an Increased Risk of Pneumococcal Infection
The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of GSK
Biologicals' 10Pn-PD-DiT vaccine in children aged between 2 and 17 years of age having
asplenia, splenic dysfunction or complement deficiencies.
In addition, this study will include an age-matched control group of healthy children aged
24-59 months in order to descriptively compare the immunogenicity of 10Pn-PD-DiT vaccine in
the at-risk population to that of the general, healthy population one month after each
pneumococcal vaccination.
The protocol has been amended to clarify the definition of priming status to consider for inclusion of subjects in the primed groups. ;
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|---|---|---|---|
| Completed |
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Phase 2 | |
| Completed |
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Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
|
Phase 3 | |
| Completed |
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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.
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N/A | |
| Completed |
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N/A | |
| Completed |
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Evaluation of Pneumococcal Vaccine Formulations in Elderly
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Phase 1 | |
| Completed |
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Phase 3 | |
| Completed |
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Phase 3 | |
| Completed |
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Assess the Immunogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
|
Phase 3 | |
| Completed |
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Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
|
Phase 3 | |
| Withdrawn |
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Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children
|
N/A | |
| Completed |
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Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
|
Phase 3 | |
| Completed |
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Study to Evaluate the Safety and Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine in Preterm Infants
|
Phase 3 | |
| Completed |
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Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
|
Phase 2 | |
| Withdrawn |
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Study to Identify and Characterize Bacteria Causing Acute Otitis Media in Young Children in Turkey
|
N/A | |
| Completed |
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A Lot-to-lot Consistency (3 Lots of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine) & Non-inferiority Study
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Phase 3 | |
| Completed |
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Safety and Immunogenicity of the Liquid Formulation of Group B Streptococcus Trivalent Vaccine and of the Lyophilized Formulation of Group B Streptococcus Trivalent Vaccine
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Phase 2 | |
| Completed |
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Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment
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Phase 4 | |
| Completed |
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Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Mali
|
Phase 3 | |
| Completed |
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|
Phase 3 |