Infections, Streptococcal Clinical Trial
Official title:
Evaluate Immunogenicity, Safety & Reactogenicity of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine Given as Catch-up Immunization in Children Older Than 7 mo of Age or as 3-dose Primary Immunization in Children Before 6 mo of Age
The purpose of this phase IIIb study is to determine whether children who have not received a
3-dose primary vaccination with the pneumococcal conjugate vaccine before their 6 months of
age, can receive the vaccine as part of a catch-up immunization schedule. The immunogenicity,
safety and reactogenicity of GSK Biologicals' pneumococcal conjugate vaccine will be
evaluated for four different age groups with different schedules:
< 6 months of age group: 3-dose primary vaccination + a booster dose. 7 to 11 months of age
group: 2-dose primary vaccination + a booster dose. 12 to 23 months of age group: 2-dose
vaccination; no booster dose. 24 months to 5 years of age group: 1-dose vaccination; no
booster dose. Children below 6 months of age will receive concomitantly a DTPa-IPV/Hib
vaccine.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007 ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants
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Phase 2 | |
| Completed |
NCT00370396 -
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.
|
N/A | |
| Completed |
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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 |
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 |
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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 |
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 |
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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
|
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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Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
|
Phase 3 | |
| Completed |
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Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children
|
Phase 2 |