Last updated: 07/17/2024 15:14:49

COMPAS (Clinical Otitis Media & Pneumonia Study): pneumonia & Acute Otitis Media (AOM ) efficacy study of the pneumococcal conjugate vaccine

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GSK study ID
109563
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Clinicaltrials.gov ID
NCT00466947
See results summary
EudraCT ID
2011-002076-16
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Double (Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of subjects with a first episode reported of bacterial community acquired pneumoniae (B-CAP)

Timeframe: Any time from 2 weeks after Dose 3 up to 31 August 2010

Secondary outcomes:

Number of subjects with serious adverse events (SAEs)

Timeframe: Throughout the study (Month 0 to Month 22-25)

Number of subjects with any unsolicited adverse event (AE), in the Panama Subset

Timeframe: Throughout the study (Month 0 to Month 22-25)

Number of subjects with solicited local symptoms post primary vaccination in the Immunogenicity and Tolerability Subset

Timeframe: Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration

Number of subjects with solicited local symptoms post booster vaccination in the Immunogenicity and Tolerability Subset

Timeframe: Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration

Number of subjects with solicited local symptoms post primary vaccination in the Immunogenicity and Tolerability Subset

Timeframe: Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration

Number of subjects with solicited local symptoms post booster vaccination in the Immunogenicity and Tolerability Subset, for the Control Group

Timeframe: Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration.

Number of subjects with solicited general symptoms post primary vaccination in the Immunogenicity and Tolerability Subset

Timeframe: Within the 4-days (Days 0–3) follow-up period across the 3 doses of the primary study vaccine administration

Number of subjects with solicited general symptoms post booster vaccination in the Immunogenicity and Tolerability Subset

Timeframe: Within the 4-days (Days 0–3) follow-up period following the booster vaccine administration

Number of subjects with a first episode reported of clinically confirmed acute otitis media (AOM) (C-AOM), in the Panama Subset

Timeframe: Any time from 2 weeks after Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of community acquired pneumoniae (CAP) with alveolar consolidation or pleural effusion on the chest X-ray (CXR) (C-CAP)

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to any bacterial pathogen, in the Panama Subset

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to Streptococcus pneumoniae (S. pn.) vaccine serotypes, in the Panama Subset

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to Streptococcus pneumoniae (S. pn.) cross-reactive serotypes, in the Panama Subset.

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to other pneumococcal serotypes, in the Panama Subset.

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to Haemophilus influenzae (H. influenzae), in the Panama Subset

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to non-typeable Haemophilus influenzae (H. influenzae), in the Panama Subset

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of bacteriologically confirmed acute otitis media (AOM) (B-AOM) due to other AOM pathogens, in the Panama Subset

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of community acquired pneumoniae (CAP) with alveolar consolidation or pleural effusion on the Chest X-ray (CXR) (C-CAP) with positive respiratory viral test (RVT)

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of community acquired pneumoniae (CAP) with any abnormal CXR with positive respiratory viral test (RVT)

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of bacterial community acquired pneumoniae (B-CAP) with positive respiratory viral test (RVT).

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of suspected community acquired pneumoniae (CAP) (S-CAP)

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of community acquired pneumoniae (CAP) with any abnormal chest X-ray (CXR)

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of suspected community acquired pneumoniae (CAP) (S-CAP) with C reactive protein (CRP) >= cut-off, regardless of chest X-ray (CXR) reading

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of CAP with either alveolar consolidation/pleural effusion on chest X-ray (CXR) (C-CAP) or with non-alveolar infiltrates (NAI-CAP) but with C reactive protein (CRP) >= cut-off.

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of vaccine-type invasive pneumococcal disease (VT-IPD).

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of a bacteriologically confirmed invasive pneumococcal disease (Bact.-conf. ID).

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of pneumococcal invasive disease (Pneumococcal ID)

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of Invasive Pneumococcal Disease (IPD) due to Streptococcus (S. pn.) cross-reactive pneumococcal serotypes.

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of Invasive Pneumococcal Disease (IPD) due to pneumococcal serotypes other than Streptococcus (S. pn.) vaccine and cross-reactive serotypes.

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with a first episode reported of invasive disease (ID) due to Haemophilus influenzae

Timeframe: Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25

Number of subjects with Streptococcus pneumoniae (S. pn.) vaccine serotypes identified in nasopharyngeal swabs, in the Carriage Subset.

Timeframe: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25

Number of subjects with Streptococcus pneumoniae (S. pn.) cross-reactive serotypes identified in nasopharyngeal swabs, in the Carriage Subset.

Timeframe: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25

Number of subjects with Streptococcus pneumoniae (S. pn.) serotypes identified in nasopharyngeal swabs other than the Synflorix vaccine and cross-reactive serotypes, in the Carriage Subset

Timeframe: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25

Number of subjects with H. influenzae strains identified in nasopharyngeal swabs, in the Carriage subset

Timeframe: At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25

Number of subjects with acquisition of new Streptococcus pneumoniae strains identified in nasopharyngeal swabs, in the Carriage Subset

Timeframe: At Months 10-13, 13-16, 14-17, 16-19 and 22-25

Number of subjects with acquisition of new Haemophilus influenzae strains identified in nasopharyngeal swabs, in the Carriage Subset.

Timeframe: At Months 10-13, 13-16, 14-17, 16-19 and 22-25

Number of subjects with any antibiotic prescription at least once during the entire study period, in the Carriage Subset.

Timeframe: Throughout the study (Month 0 to Month 22-25)

Pneumococcal antibody concentrations against pneumococcal vaccine serotypes, in the Immunogenicity and Tolerability Subset.

Timeframe: At Month 5, one month after the third dose of primary vaccination

Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset

Timeframe: At Month 5, one month after the third dose of primary vaccination

Antibody concentrations against pneumococcal vaccine serotypes, in the Immunogenicity and Tolerability Subset.

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Number of subjects with antibody concentrations against pneumococcal vaccine serotypes >= 0.20 micrograms per milliliter (µg/mL), in the Immunogenicity and Tolerability Subset

Timeframe: At Month 5, one month after the third dose of primary vaccination

Number of subjects with antibody concentrations against pneumococcal cross-reactive serotypes 6A and 19A >= 0.20 micrograms per milliliter (µg/mL), in the Immunogenicity and Tolerability Subset

Timeframe: At Month 5, one month after the third dose of primary vaccination

Number of subjects with antibody concentrations against pneumococcal vaccine serotypes >= 0.20 micrograms per milliliter (µg/mL), in the Immunogenicity and Tolerability Subset

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Number of subjects with pneumococcal antibody concentrations against cross-reactive serotypes 6A and 19A higher >= 0.20 micrograms per milliliter (µg/mL), in the Immunogenicity and Tolerability Subset

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Number of subjects with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 microgram per milliliter (µg/mL), in the Immunogenicity and Tolerability Subset

Timeframe: At Month 5, one month after the third dose of primary vaccination

Number of subjects with pneumococcal antibody concentrations against serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset

Timeframe: At Month 5, one month after the third dose of primary vaccination

Number of subjects with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 0.05 microgram per milliliter (µg/mL), in the Immunogenicity and Tolerability Subset

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST

Number of subjects with pneumococcal antibody concentrations against serotypes 6A and 19A >= 0.05 µg/mL, in the Immunogenicity and Tolerability Subset

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) .

Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset

Timeframe: At Month 5, one month after the third dose of primary vaccination,

Titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A, in the Immunogenicity and Tolerability Subset

Timeframe: At Month 5, one month after the third dose of primary vaccination

Titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F, in the Immunogenicity and Tolerability Subset

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Titers for Opsonophagocytic activity against pneumococcal serotypes 6A and 19A in the Immunogenicity and Tolerability Subset

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Number of subjects with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 8, in the Immunogenicity and Tolerability Subset

Timeframe: At Month 5, one month after the third dose of primary vaccination

Number of subjects with titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset

Timeframe: At Month 5, one month after the third dose of primary vaccination

Number of subjects with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8, in the Immunogenicity and Tolerability Subset

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Number of subjects with titers for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A >= 8, in the Immunogenicity and Tolerability Subset

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST).

Concentrations of antibodies against protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset

Timeframe: At Month 5, one month after the third dose of primary vaccination

Concentrations of antibodies against protein D (ANTI-PD), in the Immunogenicity and Tolerability Subset

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST)

Number of subjects with anti-protein D (ANTI-PD) antibody concentrations >= 100 enzyme-linked immunosorbent assay units per milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset

Timeframe: At Month 5, one month after the third dose of primary vaccination

Number of subjects with anti-protein D (ANTI-PD) antibody concentrations >= 100 enzyme-linked immunosorbent assay units per milliliter ( EL.U/mL), in the Immunogenicity and Tolerability Subset.

Timeframe: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST

Interventions:
Biological/vaccine: Pneumococcal conjugate vaccine GSK1024850A
Biological/vaccine: Havrix
Biological/vaccine: Engerix-B
Biological/vaccine: Infanrix hexa
Biological/vaccine: GSK Biologicals’ DTPa-IPV/Hib vaccine
Enrollment:
23802
Observational study model:
Not applicable
Primary completion date:
2010-31-08
Time perspective:
Not applicable
Clinical publications:
Silfverdal SA et al. (2016) Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 16(2):109-121.
Sáez-Llorens X et al. (2017) Efficacy of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine against acute otitis media and nasopharyngeal carriage in Panamanian children - A randomized controlled trial. Hum Vaccin Immunother. 1-16. doi: 10.1080/21645515.2017.1287640. [Epub ahead of print].
Tregnaghi MW et al. (2014) Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial. PLoS Med. 11(6):e1001657.
Medical condition
Infections, Streptococcal
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
June 2007 to July 2011
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
6 - 16 weeks
Accepts healthy volunteers
Yes
  • 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 community acquired pneumonia (CAP), invasive disease and acute otitis media (AOM) •Written informed consent obtained from the parent or guardian of the subject.
  • 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).
Inclusion and exclusion 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 community acquired pneumonia (CAP), invasive disease and acute otitis media (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 Streptococcus. 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 •For Colombia: infants with low birth weight ( less than (<) 2.500 grams)

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Cali, Colombia
Status
Study Complete
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Location
GSK Investigational Site
Panama, Panamá, Panama
Status
Study Complete
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Location
GSK Investigational Site
La Banda, Santiago Del Estero, Argentina, 4300
Status
Study Complete
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Location
GSK Investigational Site
San Juan, San Juan, Argentina
Status
Study Complete
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Location
GSK Investigational Site
Santiago del Estero, Santiago Del Estero, Argentina, 4200
Status
Study Complete
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Location
GSK Investigational Site
San Juan, San Juan, Argentina, 5400
Status
Study Complete
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Location
GSK Investigational Site
Godoy Cruz, Mendoza, Argentina
Status
Study Complete
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Location
GSK Investigational Site
Albardón, San Juan, Argentina
Status
Study Complete
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Location
GSK Investigational Site
Santiago del Estero, Santiago Del Estero, Argentina
Status
Study Complete
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Location
GSK Investigational Site
Caucete, San Juan, Argentina
Status
Study Complete
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Location
GSK Investigational Site
Las Heras, Mendoza, Argentina
Status
Study Complete
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Location
GSK Investigational Site
Maipu, Argentina
Status
Study Complete
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Location
GSK Investigational Site
La Banda, Argentina, 4300
Status
Study Complete
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Location
GSK Investigational Site
San Juan, San Juan, Argentina, 5425
Status
Study Complete
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Location
GSK Investigational Site
Santiago del Estero, Argentina, 4200
Status
Study Complete
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Location
GSK Investigational Site
Cordoba, Argentina, 5000
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Villanueva, Mendoza, Argentina
Status
Study Complete
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Location
GSK Investigational Site
Santiago del Estero, Argentina, 4300
Status
Study Complete
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Location
GSK Investigational Site
san Martín, Argentina
Status
Study Complete
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Location
GSK Investigational Site
Fernandez, Santiago Del Estero, Argentina, 4200
Status
Study Complete
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Location
GSK Investigational Site
Luján de Cuyo, Mendoza, Argentina
Status
Study Complete
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Location
GSK Investigational Site
Guaymallen, Mendoza, Argentina
Status
Study Complete
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Location
GSK Investigational Site
Mendoza, Mendoza, Argentina, 5500
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2010-31-08
Actual study completion date
2011-28-07

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

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