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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-001628-38 | EudraCT Number |
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This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenarâ„¢ given at 12-18 mo of age to children primed with either pneumococcal vaccine or Prevenarâ„¢ in study 105553. Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization course in study 105553 (NCT00307554). The immune response to a booster dose of GSK Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to subjects not primed with GSK Biologicals' vaccine but with Prevenarâ„¢.
The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children primed with Prevenarâ„¢ will receive a booster dose of Prevenarâ„¢ (control group). 3rd group of children primed with Prevenarâ„¢ will receive a booster dose of GSK Biologicals' pneumococcal conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synflorix-Synflorix Group | Experimental | This group consisted of subjects previously vaccinated with the Synflorixâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorixâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
|
| Prevenar-Prevenar Group | Active Comparator | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
|
| Prevenar-Synflorix Group | Experimental | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Synflorix | Biological | 1 dose injected IM in the right thigh or deltoid. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Post Booster Between the Synflorix-Synflorix and Prevenar-Prevenar Groups | Fever was measured as rectal temperature. Assessment of occurrences of rectal temperature > 39.0 °C was performed post administration of the booster dose of pneumococcal vaccine (Synflorix™ or Prevenar™ vaccine) in this study. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available. | Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available. |
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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 | Espoo | 02100 | Finland | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19325450 | Background | Wysocki J, Tejedor JC, Grunert D, Konior R, Garcia-Sicilia J, Knuf M, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with different neisseria meningitidis serogroup C conjugate vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S77-88. doi: 10.1097/INF.0b013e318199f609. | |
| 19325447 |
| 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 |
|---|---|---|---|
| 107046 | Statistical Analysis Plan | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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During the screening the following was performed: informed consent was obtained and signed from parents or guardians of subjects, check for inclusion/exclusion criteria and contraindications/precautions was performed, and medical history of subjects was collected. Prior to vaccination, subjects' pre-vaccination body temperature was evaluated.
This study consisted of approximately 1200 subjects who were previously enrolled and had been vaccinated with either the 10Pn or 7Pn vaccine as part of the 10PN-PD-DIT-001 (105553) study (EudraCTnumber: 2005-003300-11).
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| ID | Title | Description |
|---|---|---|
| FG000 | Synflorix-Synflorix Group | This group consisted of subjects previously vaccinated with the Synflorixâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorixâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Prevenar | Biological | 1 dose injected IM in the right thigh or deltoid. |
|
| Infanrix hexa | Biological | 1 dose injected IM in the right thigh or deltoid. |
|
| Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 |
| Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available. | Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 |
| Number of Subjects With Unsolicited Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007. | Within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 |
| Number of Subjects With Serious Adverse Events (SAEs) During the Active Phase of the Study | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity . The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007. | Throughout the Active Phase of the study, that is, within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 |
| Number of Subjects With Serious Adverse Events (SAEs) During the Entire Study | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects enrolled in the ESFU Phase of the study. | Throughout the study period, from Month 0 prior to booster vaccination up to Month 6, end of the ESFU in this study 10PN-PD-DIT-007 |
| Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | A seroprotected subject as regards anti-pneumococcal serotype antibody was defined as a subject with anti-pneumococcal serotype antibody concentration above than or equal to (≥) 0.20 microgram per millilitre (μg/mL). Anti-pneumococcal serotypes antibodies assessed were antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F). Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using ≥ 0.05 μg/mL as seropositivity cut off. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Prior to (PRE) and one month after (Month 1) booster vaccination |
| Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean concentrations (GMCs), in microgram per millilitre (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Prior to (PRE) and one month (Month 1) post booster vaccination |
| Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Prior to (PRE) and one month (Month 1) post booster vaccination |
| Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA) | Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Prior to (PRE) and one month (Month 1) post booster vaccination |
| Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off for the assay for the purpose of this endpoint was ≥ 0.15 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Prior to (PRE) and one month (Month 1) post booster vaccination |
| Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT, Anti-FHA and Anti-PRN concentrations measured by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 5 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Prior to (PRE) and one month (Month 1) post booster vaccination |
| Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D and Anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 0.1 IU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Prior to (PRE) and one month (Month 1) post booster vaccination |
| Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | Anti-HBs antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in milli-International unit per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 10 mIU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Prior to (PRE) and one month (Month 1) post booster vaccination |
| Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 1, 2 and 3 antibody titers were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seroprotection cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Prior to (PRE) and one month (Month 1) post booster vaccination |
| Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens | A BST responder to PT, FHA and PRN antigens was defined as a subject with the appearance of antibodies in subjects who were seronegative prior to the booster vaccination or at least 2-fold increase of pre-booster vaccination antibody concentrations in subjects who were seropositive prior to the booster vaccination. A seropositive/seronegative subject as regards Anti-PT/-FHA/ -PRN antibodies was defined as a subject with anti-PT/-FHA/ -PRN antibody concentrations ≥ 5 Enzyme-linked Immunosorbent assay (ELISA) unit per milli-liter (EL.U/mL) | One month (Month 1) post booster vaccination |
| Helsinki |
| 00100 |
| Finland |
| GSK Investigational Site | Helsinki | 00930 | Finland |
| GSK Investigational Site | Jarvenpaa | 04400 | Finland |
| GSK Investigational Site | Jyväskylä | 40100 | Finland |
| GSK Investigational Site | Kokkola | 67100 | Finland |
| GSK Investigational Site | Kotka | 48600 | Finland |
| GSK Investigational Site | Kuopio | 70100 | Finland |
| GSK Investigational Site | Lahti | 15140 | Finland |
| GSK Investigational Site | Oulu | 90100 | Finland |
| GSK Investigational Site | Pori | 28120 | Finland |
| GSK Investigational Site | Seinäjoki | 60100 | Finland |
| GSK Investigational Site | Tampere | 33200 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Vantaa | 01300 | Finland |
| GSK Investigational Site | Vantaa | 01600 | Finland |
| GSK Investigational Site | Bernay | 27300 | France |
| GSK Investigational Site | Colombes | 92701 | France |
| GSK Investigational Site | Créteil | 94000 | France |
| GSK Investigational Site | Dax | 40100 | France |
| GSK Investigational Site | Draguignan | 83300 | France |
| GSK Investigational Site | Essey-lès-Nancy | 54270 | France |
| GSK Investigational Site | Le Havre | 76600 | France |
| GSK Investigational Site | Maromme | 76150 | France |
| GSK Investigational Site | Nice | 06300 | France |
| GSK Investigational Site | Nogent-sur-Marne | 94130 | France |
| GSK Investigational Site | Paris | 75019 | France |
| GSK Investigational Site | Rouen | 76000 | France |
| GSK Investigational Site | Saint-Quentin | 02100 | France |
| GSK Investigational Site | Bydgoszcz | 85-021 | Poland |
| GSK Investigational Site | Dębica | 39-200 | Poland |
| GSK Investigational Site | Krakow | 31-202 | Poland |
| GSK Investigational Site | Oleśnica | 56-400 | Poland |
| GSK Investigational Site | Poznan | 61-709 | Poland |
| GSK Investigational Site | Siemianowice ÅšlÄ…skie | 41-103 | Poland |
| Background |
| Chevallier B, Vesikari T, Brzostek J, Knuf M, Bermal N, Aristegui J, Borys D, Cleerbout J, Lommel P, Schuerman L. Safety and reactogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) when coadministered with routine childhood vaccines. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S109-18. doi: 10.1097/INF.0b013e318199f62d. |
| 19325452 | Background | Knuf M, Szenborn L, Moro M, Petit C, Bermal N, Bernard L, Dieussaert I, Schuerman L. Immunogenicity of routinely used childhood vaccines when coadministered with the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S97-S108. doi: 10.1097/INF.0b013e318199f61b. |
| 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. |
| 19325449 | Background | Vesikari T, Wysocki J, Chevallier B, Karvonen A, Czajka H, Arsene JP, Lommel P, Dieussaert I, Schuerman L. Immunogenicity of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) compared to the licensed 7vCRM vaccine. Pediatr Infect Dis J. 2009 Apr;28(4 Suppl):S66-76. doi: 10.1097/INF.0b013e318199f8ef. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107046 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107046 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107046 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107046 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107046 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| FG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
|
| COMPLETED |
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| NOT COMPLETED |
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|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Synflorix-Synflorix Group | This group consisted of subjects previously vaccinated with the Synflorixâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorixâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| BG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| BG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
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|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Months |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Subjects With Rectal Temperature Above (>) 39.0 Degrees Celsius (°C) Post Booster Between the Synflorix-Synflorix and Prevenar-Prevenar Groups | Fever was measured as rectal temperature. Assessment of occurrences of rectal temperature > 39.0 °C was performed post administration of the booster dose of pneumococcal vaccine (Synflorix™ or Prevenar™ vaccine) in this study. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available. | The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets. | Posted | Count of Participants | Participants | Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available. | The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets.. | Posted | Count of Participants | Participants | Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 |
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| Secondary | Number of Subjects With Any and Any Grade 3 Solicited General Symptoms | Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal everyday activities. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects with results available. | The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects, who completed their symptom sheets.. | Posted | Count of Participants | Participants | Within 4 days (Days 0-3) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 |
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| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007. | The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) During the Active Phase of the Study | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity . The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007. | The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Throughout the Active Phase of the study, that is, within 31 days (Day 0-30) after the booster vaccination at Month 0 in this study 10PN-PD-DIT-007 |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) During the Entire Study | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. "Any" is defined an incidence of a SAE regardless of intensity/severity. The analysis was performed on the Total vaccinated cohort, which included all subjects vaccinated in this study 10PN-PD-DIT-007, solely on subjects enrolled in the ESFU Phase of the study. | The analysis was performed on the Total vaccinated cohort, which included all vaccinated subjects. | Posted | Count of Participants | Participants | Throughout the study period, from Month 0 prior to booster vaccination up to Month 6, end of the ESFU in this study 10PN-PD-DIT-007 |
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| Secondary | Number of Subjects Seroprotected as Regards Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antigens - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | A seroprotected subject as regards anti-pneumococcal serotype antibody was defined as a subject with anti-pneumococcal serotype antibody concentration above than or equal to (≥) 0.20 microgram per millilitre (μg/mL). Anti-pneumococcal serotypes antibodies assessed were antibodies against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F). Analysis was performed using the 22F-inhibition Enzyme-linked immunosorbent assay (ELISA), using ≥ 0.05 μg/mL as seropositivity cut off. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | Count of Participants | Participants | Prior to (PRE) and one month after (Month 1) booster vaccination |
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| Secondary | Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, 9V, -14, -18C, -19F and -23F) - by 22F-inhibition Enzyme-linked Immunosorbent Assay (ELISA) | Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean concentrations (GMCs), in microgram per millilitre (µg/mL). The seropositivity cut-off for the assay was ≥ 0.05 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Prior to (PRE) and one month (Month 1) post booster vaccination |
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| Secondary | Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Prior to (PRE) and one month (Month 1) post booster vaccination |
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| Secondary | Antibody Concentrations to Protein D (Anti-PD) - by Enzyme-Linked Immunosorbent Assay (ELISA) | Anti-protein D (Anti-PD) antibody concentrations by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 100 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Prior to (PRE) and one month (Month 1) post booster vaccination |
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| Secondary | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off for the assay for the purpose of this endpoint was ≥ 0.15 µg/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | μg/mL | Prior to (PRE) and one month (Month 1) post booster vaccination |
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| Secondary | Anti-pertussis Toxoid (Anti-PT), Anti- Filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations | Anti-PT, Anti-FHA and Anti-PRN concentrations measured by Enzyme-Linked Immunosorbent Assay (ELISA) were calculated, expressed as geometric mean concentrations (GMCs) in ELISA unit per milli-liter (EL.U/mL) and tabulated. The seropositivity cut-off for the assay was ≥ 5 EL.U/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Prior to (PRE) and one month (Month 1) post booster vaccination |
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| Secondary | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D and Anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 0.1 IU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | Prior to (PRE) and one month (Month 1) post booster vaccination |
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| Secondary | Anti-hepatitis B Surface Antigen (HBs) Antibody Concentrations | Anti-HBs antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in milli-International unit per milliliter (IU/mL), and tabulated. The seropositivity cut-off for the assay was ≥ 10 mIU/mL. Antibody concentrations below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMC calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Prior to (PRE) and one month (Month 1) post booster vaccination |
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| Secondary | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Titers | Anti-Polio 1, 2 and 3 antibody titers were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seroprotection cut-off for the assay was ≥ 8. Antibody titers below the cut-off of the assay were given an arbitrary value of half the cut-off for the purpose of GMT calculation. For this endpoint, the analysis was performed on the according-to-protocol cohort for immunogenicity, e. a., evaluable subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | Geometric Mean | 95% Confidence Interval | Titers | Prior to (PRE) and one month (Month 1) post booster vaccination |
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| Secondary | Number of Subjects Booster (BST) Responder to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin Antigens | A BST responder to PT, FHA and PRN antigens was defined as a subject with the appearance of antibodies in subjects who were seronegative prior to the booster vaccination or at least 2-fold increase of pre-booster vaccination antibody concentrations in subjects who were seropositive prior to the booster vaccination. A seropositive/seronegative subject as regards Anti-PT/-FHA/ -PRN antibodies was defined as a subject with anti-PT/-FHA/ -PRN antibody concentrations ≥ 5 Enzyme-linked Immunosorbent assay (ELISA) unit per milli-liter (EL.U/mL) | The analysis was performed on the According-To-Protocol (ATP) Cohort for immunogenecity, which included all evaluable subjects whith available immunogenecity data. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination. | Posted | Count of Participants | Participants | One month (Month 1) post booster vaccination |
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From Month 1 (Active Phase) and up to Month 6 (Extended Safety Follow-Up)
Not provided
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-Synflorix Group | This group consisted of subjects previously vaccinated with the Synflorixâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorixâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. | 0 | 737 | 33 | 737 | 684 | 737 |
| EG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. | 0 | 92 | 6 | 92 | 85 | 92 |
| EG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. | 0 | 283 | 8 | 93 | 253 | 283 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Microcytic anaemia | Blood and lymphatic system disorders | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | Systematic Assessment |
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| Peripheral swelling | General disorders | Systematic Assessment |
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| Adenovirus infection | Infections and infestations | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Ear infection | Infections and infestations | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | Systematic Assessment |
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| Gastroenteritis rotavirus | Infections and infestations | Systematic Assessment |
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| Laryngitis | Infections and infestations | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Otitis media | Infections and infestations | Systematic Assessment |
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| Pharyngitis | Infections and infestations | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | Systematic Assessment |
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| Toxicity to various agents | Injury, poisoning and procedural complications | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
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| Weight gain poor | Metabolism and nutrition disorders | Systematic Assessment |
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| Febrile convulsion | Nervous system disorders | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Purpura | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Injection site induration | General disorders | Systematic Assessment |
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| Irritability | Psychiatric disorders | Systematic Assessment |
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| Otitis media | Infections and infestations | Systematic Assessment |
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| Pain | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Rhinitis | Infections and infestations | Systematic Assessment |
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| Somnolence | Nervous system disorders | Systematic Assessment |
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| Swelling | General disorders | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
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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 |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C547294 | PHiD-CV vaccine |
| C586648 | 10-valent pneumococcal conjugate vaccine |
| D000069443 | Heptavalent Pneumococcal Conjugate Vaccine |
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| ID | Term |
|---|---|
| D022242 | Pneumococcal Vaccines |
| D022541 | Streptococcal Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D017778 | Vaccines, Combined |
Not provided
Not provided
| Male |
|
| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
|
|
| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
|
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| Prevenar-Prevenar Group |
This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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| OG001 | Prevenar-Prevenar Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Prevenarâ„¢ vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Prevenarâ„¢ vaccine, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
| OG002 | Prevenar-Synflorix Group | This group consisted of subjects previously vaccinated with the Prevenarâ„¢ vaccine as part of a previous study by GSK Biologicals - the 10PN-PD-DIT-001 (105553) study (EuDRA-CT number: 2005-003300-11). As part of the 105553 study, subjects had received a 3-dose primary vaccination of Synflorix vaccine at 2, 3 and 4 months of age (injected intramuscularly [IM] in the right thigh) co-administered with Infanrix hexaâ„¢ vaccine, except for the second dose in France, which was co-administered with Infanrixâ„¢ IPV Hib, injected intramuscularly in the left thigh. As part of this study, at 12-18 months of age, subjects received a booster dose of Synflorixâ„¢, injected IM in the right thigh or deltoid, co-administered with Infanrix hexaâ„¢ vaccine, injected IM in the left thigh or deltoid. |
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