Infections, StreptococcalPhase 3NCT00466947

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

A Phase 3 study testing Pneumococcal conjugate vaccine GSK1024850A, Havrix and Engerix-B in people with Infections, Streptococcal, run by GlaxoSmithKline at 22 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 6 to 16 weeksHealthy volunteers can take part
Conditions the study is for: Infections, Streptococcal
What is being tested?: Pneumococcal conjugate vaccine GSK1024850A, Havrix and Engerix-B
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23,802 participants
Where: 22 sitesin 3 countries
Study dates: 28 Jun 2007to 28 Jul 2011
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 16 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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 locations and contacts

22 sites in 3 countries.

Country

City, postcode or hospital

22 sites in 3 countries

Argentina20 sites

GSK Investigational Site
Albardón, San Juan Province
GSK Investigational Site
Caucete, San Juan Province
GSK Investigational Site
Córdoba, 5000
GSK Investigational Site
Fernandez, Santiago del Estero Province, 4200
GSK Investigational Site
Godoy Cruz, Mendoza Province
GSK Investigational Site
La Banda, Santiago del Estero Province, 4300
GSK Investigational Site
La Banda, 4300
GSK Investigational Site
Las Heras, Mendoza Province
GSK Investigational Site
Lujan de Cuyo, Mendoza Province
GSK Investigational Site
Maipu
GSK Investigational Site
Mendoza, 5500
GSK Investigational Site
San Juan, 5400
GSK Investigational Site
San Juan, 5425
GSK Investigational Site
San Juan
GSK Investigational Site
San Martin
GSK Investigational Site
Santiago del Estero, 4200
GSK Investigational Site
Santiago del Estero, 4300
GSK Investigational Site
Santiago del Estero
GSK Investigational Site
Villa Nueva, Mendoza Province
GSK Investigational Site
Villanueva, Mendoza Province

Other trials in Argentina

Colombia1 site

GSK Investigational Site
Cali

Other trials in Colombia

Panama1 site

GSK Investigational Site
Panama City

Other trials in Panama

About this study

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

Read the 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
Being tested: Pneumococcal conjugate vaccine GSK1024850A, Havrix, Engerix-B, Infanrix hexa, GSK Biologicals' DTPa-IPV/Hib vaccine
Keywords: Otitis media, Pneumonia, Community acquired pneumonia (CAP), Pneumococcal disease, Booster vaccination, Immunogenicity, Pneumococcal vaccine, Safety, Efficacy, Carriage
Medical subject headings: Streptococcal Infections, Otitis Media, Pneumonia, Community-Acquired Pneumonia, Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pneumococcal conjugate vaccine GSK1024850ABiological
Intramuscular injection, 4 doses
HavrixBiological
Also called Hepatitis A vaccine
Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group
Engerix-BBiological
Also called Hepatitis B vaccine
Intramuscular injection, 3 doses
Infanrix hexaBiological
Also called DTPa-HBV-IPV/Hib
Intramuscular injection,3 doses
GSK Biologicals' DTPa-IPV/Hib vaccineBiological
Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group

Study groups in NCT00466947
Study group	Role	What they receive
Synflorix Group	Experimental	Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose). Receives: Biological: Pneumococcal conjugate vaccine GSK1024850A; Biological: Havrix; Biological: Infanrix hexa; Biological: GSK Biologicals' DTPa-IPV/Hib vaccine
Control Group	Active comparator	Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh. Receives: Biological: Havrix; Biological: Engerix-B; Biological: GSK Biologicals' DTPa-IPV/Hib vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP)
A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose. After analysis on primary outcome was performed, re-monitoring activities revealed Informed Consent Form issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome.
Measured: Any time from 2 weeks after Dose 3 up to 31 August 2010

Secondary outcomes (61)

Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Measured: Throughout the study (Month 0 to Month 22-25)
Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. The Panama Subset included all subjects from Panama.
Measured: 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
Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.
Measured: 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
Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Synflorix Group.
Measured: 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
Assessed symptoms were redness, swelling and pain. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.
Measured: 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
Assessed symptoms were redness, swelling and pain. The Immunogenicity and Safety Tolerability Subset included 500 subjects coming from Argentina and Panama respectively. This outcome measure concerns solely subjects from the Control Group.
Measured: 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
Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
Assessed symptoms were fever (defined as rectal temperature equal or higher than [>=] 38 degrees Celsius [°C]). irritability/fussiness, drowsiness, and loss of appetite. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
The Panama Subset contained all subjects enrolled in Panama.
Measured: 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)
CXR alveolar consolidation was defined as CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. CXR pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.
Measured: 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
The Panama Subset contained all subjects enrolled in Panama.
Measured: 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
The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Panama Subset contained all subjects enrolled in Panama.
Measured: 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.
The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 6A, 18B, 19A and 23A. The Panama Subset contained all subjects enrolled in Panama.
Measured: 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.
Other pneumococcal serotypes were defined for this outcome measures as non-Streptococcus pneumoniae vaccine and cross-reactive serotypes. The Panama Subset contained all subjects enrolled in Panama.
Measured: 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
The Panama Subset contained all subjects enrolled in Panama.
Measured: 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
The Panama Subset contained all subjects enrolled in Panama
Measured: 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
Other pathogens assessed included among others Moraxella catarrhalis, Group A streptococci, and Staphyloccus aureus. The Panama Subset contained all subjects enrolled in Panama.
Measured: 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)
A CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.
Measured: 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)
An "abnormal CXR" was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.
Measured: 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).
Measured: 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)
An episode of S-CAP involved either any subject who was referred to have a chest X-ray (CXR) performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI.
Measured: 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)
An "abnormal CXR" was defined as a CXR with either consolidation, pleural effusion and/or abnormal pulmonary alveolar or non-alveolar infiltrates on the digital CXR image. CXR with consolidation was defined as a CXR with a dense, often homogeneous, confluent alveolar infiltrate that could encompass an entire lobe or segment, or a fluffy, mass-like, cloud-like density that erased heart and diaphragm borders (silhouette sign) and that often contained air bronchograms. Pleural effusion was defined as a fluid collecting in the pleural space around the lung, seen radiologically as a dense rim (the same density as the chest-wall muscles) interposed between the lung and the ribs.
Measured: 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
A case of S-CAP involved either any subject who was referred to have a CXR performed as part of the clinical assessment of a febrile syndrome or an acute respiratory infection (ARI), or a hospitalized child who had a CXR performed within 2 days prior to, or within the first 3 days after hospital admission, as part of the clinical assessment of a febrile syndrome or an ARI. CRP cut-off values applied for this outcome measure were 40 milligrams per liter (mg/L), 80 mg/L, and 120 mg/L.
Measured: 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.
CRP cut-off values applied for this outcome measure were 80 milligrams per liter (mg/L), and 120 mg/L.
Measured: 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).
A VT-IPD was defined as a bacteriologically culture confirmed invasive pneumococcal disease case caused by any of the 10 pneumococcal Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Measured: 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).
A Bact.-conf. ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes as identified through positive culture. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Measured: 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)
A Pneumococcal ID was defined as a bacteriologically culture confirmed invasive pneumococcal disease (ID) cases due to any of the 10 Streptococcus pneumoniae vaccine serotypes. The 10 pneumococcal S. pneumoniae vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Pneumococcal ID cases were identified through non-culture pneumococcal diagnostic tests with additional non-culture vaccine type serotyping. Tests used included rapid in-vitro diagnostic tests or Latex agglutination.
Measured: 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.
The S. pn. cross-reactive serotypes assessed for this outcome measure were the serotypes 19A, 6A and 9N.
Measured: 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.
The serotypes assessed for this outcome measure included among others the pneumococcal serotypes 12F, 16F, 24F, 38 and 8.
Measured: 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
No subject was reported with any case of ID due to Haemophilus influenzae.
Measured: 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.
The 10 pneumococcal S. pn. vaccine serotypes assessed for this outcome measure were the serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
Measured: 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.
Any serotype belonging to the same serogroup as the Synflorix vaccine serotypes, but different from the vaccine serotypes, was considered for this analysis of carriage S. pn. cross-reactive serotypes. S. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
Measured: 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
1. pn. serotypes were identified using latex agglutination and by quellung reaction with omni serum. The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
Measured: 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
Results included samples confirmed as positive for Haemophilus influenzae (H. influenzae) or non-typeable H. influenzae (NTHi) after differentiation from H. haemolyticus by polymerase chain reaction (PCR) assay. The Carriage Subset contained a subgroup of 2,000 subjects enrolled in Panama.
Measured: 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
The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
Measured: 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.
The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
Measured: 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.
The Carriage Subset consisted in a subgroup of 2,000 subjects enrolled in Panama.
Measured: Throughout the study (Month 0 to Month 22-25)
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.
Antibody concentrations were measured by 22F enzyme-linked Immunosorbent Assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: At Month 5, one month after the third dose of primary vaccination
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was >= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed were the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). Serotypes assessed with the pneumococcal vaccine serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
A seropositive subject was defined as a subject with antibody concentrations against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F => 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
A seropositive subject was defined as a subject with antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A>= 0.05 µg/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
The cut-off of the assay was >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
A seropositive subject was defined as a subject with titers for opsonophagocytic activity against cross-reactive pneumococcal serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
A seropositive subject was defined as a subject with titers for opsonophagocytic activity against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
A seropositive subject was a subject with titers for opsonophagocytic activity against pneumococcal cross-reactive serotypes 6A and 19A >= 8. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
ANTI-PD concentrations are expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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
A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: 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.
A seropositive subject was defined as a subject with ANTI-PD antibody concentrations >= 100 EL.U/mL. The Immunogenicity and Tolerability Subset included 500 subjects coming from Argentina and Panama respectively.
Measured: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jun 200728 Jul 2011

First posted27 Apr 2007 (estimated)
Study start28 Jun 2007
Primary completion31 Aug 2010
Study completion28 Jul 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Infections, StreptococcalStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Care provider, Investigator
Enrolment: 23,802 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00466947
Sponsor's protocol ID: 109563
Other IDs: 2011-002076-16
Status last verified: Jul 2019
First submitted: 26 Apr 2007
Last updated: 16 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.
PubMed 26954689
Saez-Llorens X, Rowley S, Wong D, Rodriguez M, Calvo A, Troitino M, Salas A, Vega V, Castrejon MM, Lommel P, Pascal TG, Hausdorff WP, Borys D, Ruiz-Guinazu J, Ortega-Barria E, Yarzabal JP, Schuerman L. 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. 2017 Jun 3;13(6):1-16. doi: 10.1080/21645515.2017.1287640. Epub 2017 Feb 25.
PubMed 28368738
Tregnaghi MW, Saez-Llorens X, Lopez P, Abate H, Smith E, Posleman A, Calvo A, Wong D, Cortes-Barbosa C, Ceballos A, Tregnaghi M, Sierra A, Rodriguez M, Troitino M, Carabajal C, Falaschi A, Leandro A, Castrejon MM, Lepetic A, Lommel P, Hausdorff WP, Borys D, Ruiz Guinazu J, Ortega-Barria E, Yarzabal JP, Schuerman L; COMPAS Group. 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. 2014 Jun 3;11(6):e1001657. doi: 10.1371/journal.pmed.1001657. eCollection 2014 Jun.
PubMed 24892763

Want to know more?

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Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
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See locations

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All Infections, Streptococcal trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00466947
Acronym / sponsor ID: 109563
Conditions: Infections, Streptococcal
Keywords: Otitis media, Pneumonia, Community acquired pneumonia (CAP), Pneumococcal disease, Booster vaccination, Immunogenicity, Pneumococcal vaccine, Safety
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 23,802 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 28 Jun 2007 (actual)
Primary completion: 31 Aug 2010 (actual)
Study completion: 28 Jul 2011 (actual)
First posted: 27 Apr 2007 (estimated)
Results: Posted 4 Sep 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Synflorix Group	Experimental	Biological: Pneumococcal conjugate vaccine GSK1024850A, Biological: Havrix, Biological: Infanrix hexa, Biological: GSK Biologicals' DTPa-IPV/Hib vaccineSubjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
Control Group	Active comparator	Biological: Havrix, Biological: Engerix-B, Biological: GSK Biologicals' DTPa-IPV/Hib vaccineSubjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.

Who may qualify

Ages: 6 to 16 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pneumococcal conjugate vaccine GSK1024850AIntramuscular injection, 4 doses	Biological	Synflorix Group
HavrixAlso: Hepatitis A vaccineIntramuscular injection, 2 doses in Synflorix group and 3 doses in Control group	Biological	Control Group, Synflorix Group
Engerix-BAlso: Hepatitis B vaccineIntramuscular injection, 3 doses	Biological	Control Group
Infanrix hexaAlso: DTPa-HBV-IPV/HibIntramuscular injection,3 doses	Biological	Synflorix Group
GSK Biologicals' DTPa-IPV/Hib vaccineIntramuscular injection, 1 dose in Synflorix group and 4 doses in Control group	Biological	Control Group, Synflorix Group

Primary outcome

Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP)
Time frame: Any time from 2 weeks after Dose 3 up to 31 August 2010
A B-CAP episode was defined as a radiologically confirmed community acquired pneumoniae (CAP) episode with either alveolar consolidation/pleural effusion on the chest X-ray (CXR) or with non-alveolar infiltrates but with C reactive protein (CRP) higher than or equal to (>=) 40 milligrams per liter (mg/L). The results are presented for data lock point for the primary outcome analysis (31 August 2010), which was performed, as per protocol, when at least 535 first B-CAP episodes were reported from 2 weeks after the third vaccination dose. After analysis on primary outcome was performed, re-monitoring activities revealed Informed Consent Form issues for some subjects. Therefore, a sensitivity analysis excluding 144 subjects was performed. This analysis confirmed the validity of the results for primary outcome.

61 secondary outcomes

Number of Subjects With Serious Adverse Events (SAEs)
Time frame: Throughout the study (Month 0 to Month 22-25)
Number of Subjects With Any Unsolicited Adverse Event (AE), in the Panama Subset
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Throughout the study (Month 0 to Month 22-25)
Pneumococcal Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.
Time frame: 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
Time frame: At Month 5, one month after the third dose of primary vaccination
Antibody Concentrations Against Pneumococcal Vaccine Serotypes, in the Immunogenicity and Tolerability Subset.
Time frame: Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST)

Results and safety

Results posted to the registry on 4 Sep 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Synflorix Group	11,875	0
Control Group	11,863	0

Primary outcome: Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP)

Time frame: Any time from 2 weeks after Dose 3 up to 31 August 2010. Number. Unit: Subjects

Measure	Synflorix Group n = 10295	Control Group n = 10201
Value	240	304

Population analysed: Analysis was performed on the Interim ATP cohort for efficacy which included all evaluable vaccinated subjects who had received the 3-dose primary vaccination course, with available contact and efficacy data beyond Day 14 post study vaccine Dose 3, and whose parents/guardians consented to the use of the subject's data as of 31 August 2010.

61 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAEs and unsolicited AEs: throughout the study (Months 0 to 22-25). Solicited symptoms: 4-day follow-up period across the 3 doses of primary study vaccine course/ 4-day follow-up period post booster vaccination. Reports for SAEs were collected from all subjects from the Total Vaccinated cohort (TVC). Reports for unsolicited AEs and for solicited symptoms were collected from subjects from the Panama Subset and from the Immunogenicity and Tolerability Subset, respectively.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Synflorix Group	2,534 of 11,798 (21.5%)	3,530 of 3,602 (98%)	19 of 11,798
Control Group	2,668 of 11,799 (22.6%)	3,518 of 3,612 (97.4%)	26 of 11,799

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26954689Silfverdal SA, Coremans V, Francois N, Borys D, Cleerbout J. Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. 2017 Feb;16(2):109-121. doi: 10.1586/14760584.2016.1164044. Epub 2016 Sep 30.
Background: PubMed 28368738Saez-Llorens X, Rowley S, Wong D, Rodriguez M, Calvo A, Troitino M, Salas A, Vega V, Castrejon MM, Lommel P, Pascal TG, Hausdorff WP, Borys D, Ruiz-Guinazu J, Ortega-Barria E, Yarzabal JP, Schuerman L. 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. 2017 Jun 3;13(6):1-16. doi: 10.1080/21645515.2017.1287640. Epub 2017 Feb 25.
Background: PubMed 24892763Tregnaghi MW, Saez-Llorens X, Lopez P, Abate H, Smith E, Posleman A, Calvo A, Wong D, Cortes-Barbosa C, Ceballos A, Tregnaghi M, Sierra A, Rodriguez M, Troitino M, Carabajal C, Falaschi A, Leandro A, Castrejon MM, Lepetic A, Lommel P, Hausdorff WP, Borys D, Ruiz Guinazu J, Ortega-Barria E, Yarzabal JP, Schuerman L; COMPAS Group. 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. 2014 Jun 3;11(6):e1001657. doi: 10.1371/journal.pmed.1001657. eCollection 2014 Jun.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

22 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pneumococcal conjugate vaccine GSK1024850A, Havrix and Engerix-B in people with Infections, Streptococcal, run by GlaxoSmithKline at 22 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in Argentina, Colombia, Panama. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) (time frame: Any time from 2 weeks after Dose 3 up to 31 August 2010). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00466947, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019.