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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002076-16 | EudraCT Number |
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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.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007. The following vaccines will be offered by the sponsor:
In addition, all subjects will receive a dose of Hepatitis B vaccine at birth according to national recommendations and a dose of 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal conjugate vaccine GSK1024850A | Biological | Intramuscular injection, 4 doses |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Any time from 2 weeks after Dose 3 up to 31 August 2010 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Throughout the study (Month 0 to Month 22-25) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Godoy Cruz | Mendoza Province | Argentina | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26954689 | Background | 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. | |
| 28368738 | Background | 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. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 109563 | Clinical Study Report | View IPD |
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months
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Analysis on the primary outcome was performed when at least 535 first bacterial CAP episodes were reported from 2 weeks after vaccine Dose 3 (31 August 2010) with 23738 subjects (11875 and 11863 in Synflorix and Control groups) and analysis at study end was performed on 23597 subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Synflorix Group | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Outcome Analysis Period |
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| Havrix | Biological | Intramuscular injection, 2 doses in Synflorix group and 3 doses in Control group |
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| Engerix-B | Biological | Intramuscular injection, 3 doses |
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| Infanrix hexa | Biological | Intramuscular injection,3 doses |
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| GSK Biologicals' DTPa-IPV/Hib vaccine | Biological | Intramuscular injection, 1 dose in Synflorix group and 4 doses in Control group |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST |
| Las Heras |
| Mendoza Province |
| Argentina |
| GSK Investigational Site | Lujan de Cuyo | Mendoza Province | Argentina |
| GSK Investigational Site | Villa Nueva | Mendoza Province | Argentina |
| GSK Investigational Site | Villanueva | Mendoza Province | Argentina |
| GSK Investigational Site | Albardón | San Juan Province | Argentina |
| GSK Investigational Site | Caucete | San Juan Province | Argentina |
| GSK Investigational Site | Fernandez | Santiago del Estero Province | 4200 | Argentina |
| GSK Investigational Site | La Banda | Santiago del Estero Province | 4300 | Argentina |
| GSK Investigational Site | Córdoba | 5000 | Argentina |
| GSK Investigational Site | La Banda | 4300 | Argentina |
| GSK Investigational Site | Maipu | Argentina |
| GSK Investigational Site | Mendoza | 5500 | Argentina |
| GSK Investigational Site | San Juan | 5400 | Argentina |
| GSK Investigational Site | San Juan | 5425 | Argentina |
| GSK Investigational Site | San Juan | Argentina |
| GSK Investigational Site | San Martin | Argentina |
| GSK Investigational Site | Santiago del Estero | 4200 | Argentina |
| GSK Investigational Site | Santiago del Estero | 4300 | Argentina |
| GSK Investigational Site | Santiago del Estero | Argentina |
| GSK Investigational Site | Cali | Colombia |
| GSK Investigational Site | Panama City | Panama |
| 24892763 | Background | 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. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109563 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109563 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109563 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109563 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109563 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Control Group | 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 vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh. |
| Ongoing |
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| COMPLETED |
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| NOT COMPLETED |
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| Study End Analysis Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | Synflorix Group | 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). |
| BG001 | Control Group | 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 vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline measures presented below correspond to those of the subjects whose data were exploited towards analysis of results at the end of the study | Mean | Standard Deviation | Weeks |
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| Sex: Female, Male | Baseline measures presented below correspond to those of the subjects whose data were exploited towards analysis of results at the end of the study | Count of Participants | Participants |
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| Region of Enrollment | Baseline measures presented below correspond to those of the subjects whose data were exploited towards analysis of results at the end of the study | Number | Subjects |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | Subjects | Any time from 2 weeks after Dose 3 up to 31 August 2010 |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects whose data were exploited towards analysis of results at the end of the study. | Posted | Number | Subjects | Throughout the study (Month 0 to Month 22-25) |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the Panama subset. | Posted | Number | Subjects | Throughout the study (Month 0 to Month 22-25) |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course. | Posted | Number | Subjects | Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination. | Posted | Number | Subjects | Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course. | Posted | Number | Subjects | Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination. | Posted | Number | Subjects | Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration. |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the primary vaccination course. | Posted | Number | Subjects | Within the 4-days (Days 0-3) follow-up period across the 3 doses of the primary study vaccine administration |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the Immunogenicity and Tolerability subset for the booster vaccination. | Posted | Number | Subjects | Within the 4-days (Days 0-3) follow-up period following the booster vaccine administration |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks after Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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 | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | Number of Subjects With a First Episode Reported of Bacterial Community Acquired Pneumoniae (B-CAP) With Positive Respiratory Viral Test (RVT). | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Analysis was performed on the Final 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 study end. | Posted | Number | Subjects | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 |
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| Secondary | 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. | Not Posted | Dec 2050 | Any time from 2 weeks post primary vaccination Dose 3 to study end at Month 22-25 | Participants | |||||||||||||||||||||||||||||||||
| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the carriage subset. | Posted | Number | Subjects | At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25 |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the carriage subset. | Posted | Number | Subjects | At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25 |
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| Secondary | 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 | 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. | The analysis was performed on all vaccinated subjects included in the carriage subset. | Posted | Number | Subjects | At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25 |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the carriage subset. | Posted | Number | Subjects | At Months 5, 10-13, 13-16, 14-17, 16-19 and 22-25 |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the carriage subset. | Posted | Number | Subjects | At Months 10-13, 13-16, 14-17, 16-19 and 22-25 |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the carriage subset. | Posted | Number | Subjects | At Months 10-13, 13-16, 14-17, 16-19 and 22-25 |
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| Secondary | 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. | The analysis was performed on all vaccinated subjects included in the carriage subset. | Posted | Number | Subjects | Throughout the study (Month 0 to Month 22-25) |
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| Secondary | 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. | Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Month 5, one month after the third dose of primary vaccination |
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| Secondary | 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. | Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Month 5, one month after the third dose of primary vaccination |
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| Secondary | 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. | Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) |
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| Secondary | 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. | Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) |
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| Secondary | 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. | Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | At Month 5, one month after the third dose of primary vaccination |
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| Secondary | 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. | Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | At Month 5, one month after the third dose of primary vaccination |
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| Secondary | 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. | Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) |
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| Secondary | 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. | Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) |
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| Secondary | 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. | Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | At Month 5, one month after the third dose of primary vaccination |
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| Secondary | 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. | Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | At Month 5, one month after the third dose of primary vaccination |
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| Secondary | 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. | Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST |
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| Secondary | 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. | Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) . |
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| Secondary | 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. | Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Month 5, one month after the third dose of primary vaccination, |
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| Secondary | 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. | Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Month 5, one month after the third dose of primary vaccination |
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| Secondary | 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. | Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) |
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| Secondary | 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. | Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) |
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| Secondary | 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. | Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | At Month 5, one month after the third dose of primary vaccination |
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| Secondary | 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. | Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | At Month 5, one month after the third dose of primary vaccination |
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| Secondary | 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. | Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST) |
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| Secondary | 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. | Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 POST-BST and M9 POST-BST). |
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| Secondary | 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. | Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 5, one month after the third dose of primary vaccination |
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| Secondary | 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. | Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST) |
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| Secondary | 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. | Analyses were performed on the Primary According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Tolerability Subset (500 subjects in Argentina, 500 in Panama) with post primary vaccination assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | At Month 5, one month after the third dose of primary vaccination |
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| Secondary | 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. | Analyses were performed on the Booster According-to-Protocol immunogenicity cohort, including all evaluable subjects in the Immunogenicity and Safety Subset (500 subjects in Argentina, 500 in Panama) with post booster assay results against at least 1 study vaccine antigen component and concerning immunogenicity outcomes available. | Posted | Number | Subjects | Before the administration of booster vaccination (PRE), and 1 month and 9 months post booster vaccination (M1 Post-BST and M9 POST-BST |
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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.
For this study, the Total Number (#) of Participants Affected by Other (non-serious) Adverse Events (AEs) was analyzed separately for expected AEs and for unexpected AEs. A consolidated analysis of all expected and unexpected AEs was not technically possible to be performed and the relevant data are no longer available. Therefore, the Total #Participants Affected in Other Adverse Events Table is currently populated by the highest value of #Participants affected within other AE's table.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Synflorix Group | 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). | 19 | 11,798 | 2,534 | 11,798 | 3,530 | 3,602 |
| EG001 | Control Group | 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. | 26 | 11,799 | 2,668 | 11,799 | 3,518 | 3,612 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Coagulopathy | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Haemolytic anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Haemolytic uraemic syndrome | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Haemorrhagic disorder | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypersplenism | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Leukaemoid reaction | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cyanosis | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Intracardiac mass | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cerebral palsy | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Coarctation of the aorta | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Congenital absence of bile ducts | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Congenital oral malformation | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Congenital syphilis | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Cystic fibrosis | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Heart disease congenital | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Laryngomalacia | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Meningomyelocele | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Porencephaly | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Pyloric stenosis | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Retinoblastoma | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Sickle cell anaemia | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Spinal muscular atrophy | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Thalassaemia sickle cell | Congenital, familial and genetic disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperadrenalism | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Ulcerative keratitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal adhesions | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal mass | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Acute abdomen | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Appendix disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea haemorrhagic | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastritis erosive | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Ileus paralytic | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Infantile colic | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Intestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Intussusception | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Malabsorption | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Mallory-weiss syndrome | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Crying | General disorders | MedDRA | Non-systematic Assessment |
| |
| Effusion | General disorders | MedDRA | Non-systematic Assessment |
| |
| Electrocution | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hypothermia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Sudden death | General disorders | MedDRA | Non-systematic Assessment |
| |
| Sudden infant death syndrome | General disorders | MedDRA | Non-systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Hepatitis acute | Hepatobiliary disorders | MedDRA | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Immunodeficiency | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Milk allergy | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Selective iga immunodeficiency | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Abscess of eyelid | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Acarodermatitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Acquired immunodeficiency syndrome | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Adenoiditis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Adenovirus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Amoebiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Amoebic dysentery | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Ascariasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bacterial diarrhoea | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bullous impetigo | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Burn infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cat scratch disease | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cellulitis of male external genital organ | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cellulitis orbital | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Colostomy infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis chlamydial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cytomegalovirus hepatitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Dengue fever | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Dysentery | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Encephalitis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Enteritis infectious | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| External ear cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis adenovirus | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis shigella | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Giardiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Hantaviral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infected bites | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infected fistula | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infective pulmonary exacerbation of cystic fibrosis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Klebsiella sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Lymph node abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Mastoiditis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Meningitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Meningitis aseptic | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Meningitis meningococcal | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Meningitis pneumococcal | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Meningitis viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Myiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nasal abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Necrotising fasciitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Nosocomial infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Parotitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Periorbital cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pertussis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngeal abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumococcal sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumocystis jiroveci infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia adenoviral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia pneumococcal | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia respiratory syncytial viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pseudomembranous colitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pyoderma | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pyomyositis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory syncytial virus bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Roseola | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Salmonellosis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Scarlet fever | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sepsis syndrome | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Shigella infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Staphylococcal scalded skin syndrome | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Staphylococcal skin infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Streptococcal sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Thyroglossal cyst infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tracheitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Typhoid fever | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Varicella | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral rash | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral sepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Vulvovaginitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Accidental exposure | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Accidental poisoning | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Animal bite | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Back injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Burns first degree | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Burns second degree | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Carbon monoxide poisoning | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Chemical injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Chemical poisoning | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Chest injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Electric shock | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Electrical burn | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Extradural haematoma | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Eye burns | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Eyelid injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Gingival injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Herbal toxicity | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Limb crushing injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Limb traumatic amputation | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Mouth injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Near drowning | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Open fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Open wound | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Pneumonitis chemical | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Poisoning | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Postoperative fever | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Tendon injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Tongue injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Vulvovaginal injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Acid base balance abnormal | Investigations | MedDRA | Non-systematic Assessment |
| |
| Aspiration bronchial | Investigations | MedDRA | Non-systematic Assessment |
| |
| Cow's milk intolerance | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Feeding disorder neonatal | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Food intolerance | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Lactose intolerance | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Connective tissue disorder | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dactylitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Periostitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Acute lymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Hepatoblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Histiocytosis haematophagic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Nephroblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Neuroblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Retinoblastoma bilateral | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Brain oedema | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Cerebrospinal fistula | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Cns ventriculitis | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Guillain-barre syndrome | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypoxic-ischaemic encephalopathy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Infantile spasms | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Intracranial pressure increased | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Myoclonic epilepsy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Post-traumatic epilepsy | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Status epilepticus | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Viith nerve paralysis | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Cephalhaematoma | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Binge eating | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Breath holding | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Psychomotor retardation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Glomerulonephritis acute | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Nephrotic syndrome | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Oliguria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Prerenal failure | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Pyelocaliectasis | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Balanoposthitis | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Genital lesion | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Acute lung injury | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Allergic bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Apnoeic attack | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Apparent life threatening event | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asphyxia | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Infantile asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Acute haemorrhagic oedema of infancy | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Cutaneous loxoscelism | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis exfoliative | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatosis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Haemorrhagic urticaria | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Heat rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Henoch-schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash scarlatiniform | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin oedema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Alcohol use | Social circumstances | MedDRA | Non-systematic Assessment |
| |
| Physical abuse | Social circumstances | MedDRA | Non-systematic Assessment |
| |
| Finger amputation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Therapeutic hypothermia | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Toe amputation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Capillary fragility | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Extremity necrosis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Kawasaki's disease | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Non-systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Irritability | General disorders | MedDRA | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pyoderma | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Overweight | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthmatic crisis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchial hyperreactivity | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Prurigo | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination with Synflorix. Collect of results did not apply to subjects in the Control Group. |
|
| Pain | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination with Infanrix Hexa. Collect of results did not apply to subjects in the Control Group. |
|
| Redness | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination with Synflorix. Collect of results did not apply to subjects in the Control Group. |
|
| Redness | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination with Infanrix Hexa. Collect of results did not apply to subjects in the Control Group. |
|
| Redness | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination with Infanrix-IPV/Hib. Collect of results did not apply to subjects in the Synflorix Group. |
|
| Redness | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination with Engerix. Collect of results did not apply to subjects in the Synflorix Group. |
|
| Swelling | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination with Synflorix. Collect of results did not apply to subjects in the Control Group. |
|
| Swelling | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination with Infanrix Hexa. Collect of results did not apply to subjects in the Control Group. |
|
| Swelling | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination with Infanrix-IPV/Hib. Collect of results did not apply to subjects in the Synflorix Group. |
|
| Swelling | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination with Engerix. Collect of results did not apply to subjects in the Synflorix Group. |
|
| Pain | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination with Synflorix. Collect of results did not apply to subjects in the Control Group. |
|
| Pain | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination with Infanrix-IPV/Hib. |
|
| Pain | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination with Havrix. Collect of results did not apply to subjects in the Synflorix Group. |
|
| Redness | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination with Synflorix. Collect of results did not apply to subjects in the Control Group. |
|
| Redness | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination with Infanrix-IPV/Hib. |
|
| Redness | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination with Havrix. Collect of results did not apply to subjects in the Synflorix Group. |
|
| Swelling | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination with Synflorix. Collect of results did not apply to subjects in the Control Group. |
|
| Swelling†| General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination with Infanrix-IPV/Hib. |
|
| Swelling | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination with Havrix. Collect of results did not apply to subjects in the Synflorix Group. |
|
| Drowsiness | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination |
|
| Fever (rectal temperature >= 38.0°C) | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination |
|
| Irritability | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination |
|
| Loss of appetite | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination |
|
| Drowsiness | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination |
|
| Fever (rectal temperature >= 38.0°C) | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination |
|
| Irritability | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination |
|
| Loss of appetite | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post booster vaccination |
|
| PAIN | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination with Infanrix-IPV/Hib. Collect of results did not apply to subjects in the Synflorix Group. |
|
| PAIN | General disorders | MedDRA | Systematic Assessment | AE collected in subjects in the Immunogenicity and Tolerability Subset post primary vaccination with Engerix. Collect of results did not apply to subjects in the Synflorix Group. |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D010033 | Otitis Media |
| D011014 | Pneumonia |
| D000098968 | Community-Acquired Pneumonia |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017714 | Community-Acquired Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D022362 | Hepatitis A Vaccines |
| C075654 | Engerix-B |
| D017325 | Hepatitis B Vaccines |
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
| Physician Decision |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Other - Forbidden vaccination |
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| Other - Subject without a legal guardian |
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| Other - Unconformity in team's treatment |
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| Male |
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| Columbia |
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| Panama |
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| Units | Counts |
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| Participants |
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| Participants |
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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. |
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| Control Group |
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. |
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| OG001 | Control Group | 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. |
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| Units | Counts |
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| Participants |
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| OG001 | Control Group | 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. |
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|
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. |
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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. |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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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.
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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. |
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