NCT00466947

COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23,802 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 6 Weeks – 16 Weeks
• Healthy volunteers: Accepted

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.

Conditions

• Infections, Streptococcal

Interventions

Type	Name	Description
BIOLOGICAL	Pneumococcal conjugate vaccine GSK1024850A	Intramuscular injection, 4 doses
BIOLOGICAL	Havrix	Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group
BIOLOGICAL	Engerix-B	Intramuscular injection, 3 doses
BIOLOGICAL	Infanrix hexa	Intramuscular injection,3 doses
BIOLOGICAL	GSK Biologicals' DTPa-IPV/Hib vaccine	Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group

Timeline

• Start date: 2007-06-28
• Primary completion: 2010-08-31
• Completion: 2011-07-28
• First posted: 2007-04-27
• Last updated: 2019-07-16
• Results posted: 2013-09-04

Locations

22 sites across 3 countries: Argentina, Colombia, Panama