Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466947
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2007-04-26
Brief Title:
COMPAS Clinical Otitis Media Pneumonia Study Pneumonia Acute Otitis Media AOM Efficacy Study of the Pneumococcal Conjugate Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-002076-16 | EUDRACT_NUMBER | None | None |