Infections, Streptococcal Clinical Trial
Official title:
COMPAS: A Phase III Study to Demonstrate Efficacy of GSK Biologicals' 10-valent Pneumococcal Vaccine (GSK1024850A) Against Community Acquired Pneumonia and Acute Otitis Media
This is a study in a large number of healthy children less than 3 years old to measure the efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate vaccine (Synflorix vaccine, or GSK1024850A) to prevent cases of pneumonia (lung infection) likely caused by bacteria (Streptococcus pneumoniae and Haemophilus influenzae) or cases of otitis media (ear infection) in children under 3 years old.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007. The following vaccines will be offered by the sponsor:
- Two doses of hepatitis A vaccine will be offered to all subjects to comply with national
recommendations.
- NeisVac-C vaccine against Neisseria meningitis group C will be offered to all subjects
in Argentina at 12 months of age.
- Varicella vaccine will be offered to all subjects in Colombia and Panama at 12 months of
age.
- Two doses of Rotarix vaccine will be offered to all subjects in Colombia within the
first six months of life.
In addition, all subjects will receive a dose of Hepatitis B vaccine at birth according to
national recommendations and a dose of measles, mumps and rubella (MMR) vaccine at 12 to 15
months of age according to local Extended Program of Immunization (EPI) .
These vaccines will not be provided by the sponsor. The protocol posting has been updated
according to the amendment of the protocol dated 25 Nov 2008. The protocol posting has been
updated according to the amendment of the protocol dated 14 December 2009. The protocol
posting has been updated according to the amendment of the protocol dated 09 September 2010.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 2 | |
| Completed |
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|
Phase 3 | |
| Completed |
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N/A | |
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N/A | |
| Completed |
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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 | |
| Completed |
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|
Phase 3 | |
| Withdrawn |
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|
N/A | |
| Completed |
NCT00370227 -
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|
Phase 3 | |
| Completed |
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|
Phase 3 | |
| Completed |
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|
Phase 2 | |
| Withdrawn |
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|
N/A | |
| Completed |
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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 |