COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & AOM Efficacy Study of the Pneumococcal Conjugate Vaccine - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00466947

Purpose

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

MedlinePlus related topics: Ear Infections Flu Hepatitis Hepatitis A Pneumonia

Drug Information available for: Hepatitis B Vaccines Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines Hepatitis A Vaccines Infanrix hexa

U.S. FDA Resources

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)

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of likely bacterial Community Acquired Pneumonia (CAP) cases [ Designated as safety issue: No ]
In a subset, occurrence of clinically confirmed Acute Otitis Media (AOM) cases [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of serious adverse events [ Time Frame: From the administration of the first vaccine dose up to study end ] [ Designated as safety issue: Yes ]
In a subset, occurrence of any unsolicited adverse event [ Time Frame: From the administration of the first vaccine dose at 2 months of age up to 24-27 months of age ] [ Designated as safety issue: Yes ]
In a subset, occurrence of solicited local symptoms [ Time Frame: Within 4 days after each study vaccine administration ] [ Designated as safety issue: Yes ]
In a subset, occurrence of solicited general symptoms [ Time Frame: Within 4 days after each study vaccine administration ] [ Designated as safety issue: Yes ]
In a subset, antibody concentrations against pneumococcal serotypes [ Time Frame: One month after the third dose, just before the booster dose, one month post-booster dose of GSK Biologicals' 1024850A and at last scheduled visit ] [ Designated as safety issue: No ]
In a subset, Opsonophagocytic activity against pneumococcal serotypes [ Time Frame: One month after the third dose, just before the booster dose, one month post-booster dose of GSK Biologicals' 1024850A and at last scheduled visit ] [ Designated as safety issue: No ]
In a subset, antibody concentrations against protein D [ Time Frame: One month after the third dose, just before the booster dose, one month post-booster dose of GSK Biologicals' 1024850A and at last scheduled visit ] [ Designated as safety issue: No ]
Occurrence of CAP cases with alveolar consolidation or pleural effusion on the Chest X-ray (CRX) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
In a subset, occurrence of bacteriologically confirmed AOM cases (B-AOM) caused by vaccine serotypes, cross-reactive & other pneumococcal serotypes or by H. influenzae [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Occurrence of confirmed CAP cases associated with respiratory viral infection [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Occurrence of suspected CAP cases [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Occurrence of CAP cases with any abnormal CXR [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Occurrence of suspected CAP cases with CRP >=40 mg/L, >=80 mg/L or >=120 mg/L regardless of CXR reading [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Occurrence of CAP cases with either alveolar consolidation/pleural effusion on the chest X-ray or with non-alveolar infiltrates but with CRP >=80 mg/L or >=120 mg/L [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Occurrence of bacteriologically culture confirmed Invasive Pneumococcal Disease (IPD) cases caused by any of the pneumococcal vaccine serotypes (VT-IPD) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Occurrence of VT-IPD cases identified through positive culture or through nonculture pneumococcal diagnostic tests with additional nonculture VT serotyping [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Occurrence of IPD cases due to cross-reactive pneumococcal serotypes and other pneumococcal serotypes [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Occurrence of invasive disease cases due to H. influenzae [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
In a subset, occurrence of vaccine serotypes, cross-reactive or other S. pneumoniae serotypes and H. influenzae in the nasopharynx [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
In a subset, acquisition of new S. pneumoniae and/or H. influenzae strains in the nasopharynx [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
In a subset, occurrence of antibiotic prescriptions [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]

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
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

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 MMR vaccine at 12 to 15 months of age according to local EPI. These vaccines will not be provided by the sponsor.

Eligibility

Ages Eligible for Study:	6 Weeks to 16 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

A male or female between, and including, 6 and 16 weeks of age at the time of the first vaccination. Pre-term born infants can be included in the study starting from 8 weeks of chronological age at the time of first vaccination and up to 16 weeks of chronological age
Subjects should be living in the area covered by the surveillance system for CAP, invasive disease and AOM
Written informed consent obtained from the parent or guardian of the subject.
Free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study), that would contraindicate the initiation of routine immunizations outside a clinical trial context.
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol

Exclusion Criteria:

Use of any investigational or non-registered drug or planned use during the study period.
Use or planned use of any investigational or non-registered vaccine other than the study vaccine(s).
Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis A and/or S. pneumoniae. Locally recommended EPI vaccines to be given at birth are allowed, but should be administered at least one month before the first dose of the study vaccine .Other locally recommended vaccines are always allowed, even if concomitantly administered with the study vaccines.
Previous or planned vaccination with a registered pneumococcal vaccine such as Prevnar is not allowed. If Prevnar immunization needs to be initiated, due to the presence of a high risk disease for pneumococcal infections for which the Prevnar vaccine is made locally available, the subject can not be enrolled in the study and should be referred to the specific Prevnar immunization program.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
History of any neurologic disorders or seizures.
Acute disease at the time of enrolment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00466947

Locations

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
san Martín, Argentina
GSK Investigational Site
Mendoza, Argentina, 5500
GSK Investigational Site
San Juan, Argentina, 5400
GSK Investigational Site
San Juan, Argentina
GSK Investigational Site
San Juan, Argentina, 5425
Argentina, Mendoza
GSK Investigational Site
Luján de Cuyo, Mendoza, Argentina
GSK Investigational Site
Villanueva, Mendoza, Argentina
GSK Investigational Site
Guaymallen, Mendoza, Argentina
GSK Investigational Site
Godoy Cruz, Mendoza, Argentina
GSK Investigational Site
Las Heras, 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
GSK Investigational Site
Ciudad de Panama - La Chorrera, Panama
GSK Investigational Site
David, Panama
GSK Investigational Site
Panama, Panama
Panama, Panamá
GSK Investigational Site
Panama, Panamá, Panama

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	109563
Study First Received:	April 26, 2007
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00466947
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by GlaxoSmithKline:

Pneumococcal vaccine
Pneumococcal disease
Efficacy
Safety

Immunogenicity
Carriage
Booster vaccination
Otitis media

Study placed in the following topic categories:

Virus Diseases
Haemophilus influenzae
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases

Otitis
Otitis Media
Influenza, Human
Orthomyxoviridae Infections
Ear Diseases
Pneumonia

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 15, 2009