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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00466947 |
This is a study in a large number of healthy children less than 3 years old to measure the efficacy of GSK Biologicals' pneumococcal conjugate candidate vaccine 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.
Condition | Intervention | Phase |
---|---|---|
Pneumonia & AOM Caused by S. Pneumoniae & H. Influenzae |
Biological: GSK Biologicals' DTPa-IPV/Hib vaccine Biological: Havrix Biological: Pneumococcal conjugate vaccine GSK1024850A Biological: Engerix-B Biological: Infanrix hexa |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | COMPAS: Phase III , Double-Blind, Randomized Study to Demonstrate Efficacy of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A) Against Community Acquired Pneumonia and Acute Otitis Media (AOM) |
Estimated Enrollment: | 24000 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group B: Active Comparator |
Biological: GSK Biologicals' DTPa-IPV/Hib vaccine
Intramuscular injection, 1 dose in group A and 4 doses in group B
Biological: Havrix
Intramuscular injection, 2 doses in group A and 3 doses in group B
Biological: Engerix-B
Intramuscular injection, 3 doses
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Group A: Experimental |
Biological: GSK Biologicals' DTPa-IPV/Hib vaccine
Intramuscular injection, 1 dose in group A and 4 doses in group B
Biological: Havrix
Intramuscular injection, 2 doses in group A and 3 doses in group B
Biological: Pneumococcal conjugate vaccine GSK1024850A
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection,3 doses
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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:
In addition, all subjects will receive a dose of Hepatitis B vaccine at birth according to national recommendations and a dose of MMR vaccine at 12 to 15 months of age according to local EPI. These vaccines will not be provided by the sponsor.
Ages Eligible for Study: | 6 Weeks to 16 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Argentina | |
GSK Investigational Site | |
san Martín, Argentina | |
GSK Investigational Site | |
Santiago del Estero, Argentina, 4200 | |
GSK Investigational Site | |
Santiago del Estero, Argentina, 4300 | |
GSK Investigational Site | |
La Banda, Argentina, 4300 | |
GSK Investigational Site | |
Maipu, Argentina | |
GSK Investigational Site | |
Maipu, Argentina | |
GSK Investigational Site | |
San Juan, Argentina, 5400 | |
GSK Investigational Site | |
San Juan, Argentina | |
GSK Investigational Site | |
San Juan, Argentina | |
GSK Investigational Site | |
San Juan, Argentina, 5425 | |
GSK Investigational Site | |
San Juan, Argentina, 5400 | |
GSK Investigational Site | |
Mendoza, Argentina, 5500 | |
Argentina, Mendoza | |
GSK Investigational Site | |
Godoy Cruz, Mendoza, Argentina | |
GSK Investigational Site | |
Las Heras, Mendoza, Argentina | |
GSK Investigational Site | |
Villanueva, Mendoza, Argentina | |
GSK Investigational Site | |
Luján de Cuyo, Mendoza, Argentina | |
GSK Investigational Site | |
Guaymallen, Mendoza, Argentina | |
Argentina, San Juan | |
GSK Investigational Site | |
Caucete, San Juan, Argentina | |
GSK Investigational Site | |
Albardón, San Juan, Argentina | |
Argentina, Santiago Del Estero | |
GSK Investigational Site | |
La Banda, Santiago Del Estero, Argentina, 4300 | |
GSK Investigational Site | |
Fernandez, Santiago Del Estero, Argentina, 4200 | |
Colombia | |
GSK Investigational Site | |
Cali, Colombia | |
Panama, Panamá | |
GSK Investigational Site | |
Panama, Panamá, Panama | |
GSK Investigational Site | |
Panama, Panamá, Panama |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 109563 |
Study First Received: | April 26, 2007 |
Last Updated: | April 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00466947 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica |
Pneumococcal vaccine Pneumococcal disease Efficacy Safety |
Immunogenicity Carriage Booster vaccination Otitis media |
Virus Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases Otitis |
Haemophilus Influenzae Otitis Media Influenza, Human Orthomyxoviridae Infections Ear Diseases Pneumonia |
Virus Diseases RNA Virus Infections Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Lung Diseases |
Otitis Otitis Media Influenza, Human Orthomyxoviridae Infections Ear Diseases Pneumonia |