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

PHASE3CompletedINTERVENTIONAL
Enrollment

23,802

Participants

Timeline

Start Date

June 28, 2007

Primary Completion Date

August 31, 2010

Study Completion Date

July 28, 2011

Conditions
Infections, Streptococcal
Interventions
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

Trial Locations (22)

4200

GSK Investigational Site, Fernández

GSK Investigational Site, Santiago del Estero

4300

GSK Investigational Site, La Banda

GSK Investigational Site, La Banda

GSK Investigational Site, Santiago del Estero

5000

GSK Investigational Site, Córdoba

5400

GSK Investigational Site, San Juan

5425

GSK Investigational Site, San Juan

5500

GSK Investigational Site, Mendoza

Unknown

GSK Investigational Site, Godoy Cruz

GSK Investigational Site, Las Heras

GSK Investigational Site, Luján de Cuyo

GSK Investigational Site, Villa Nueva

GSK Investigational Site, Villanueva

GSK Investigational Site, Albardón

GSK Investigational Site, Caucete

GSK Investigational Site, Maipú

GSK Investigational Site, San Juan

GSK Investigational Site, San Martín

GSK Investigational Site, Santiago del Estero

GSK Investigational Site, Santiago de Cali

GSK Investigational Site, Panama City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY