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 ;
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Phase 2 | |
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Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
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Phase 3 | |
Completed |
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N/A | |
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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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Phase 3 | |
Withdrawn |
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|
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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Phase 2 | |
Completed |
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Phase 4 | |
Completed |
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Phase 3 | |
Completed |
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Phase 3 | |
Completed |
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Phase 2 |