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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019730-27 | EudraCT Number |
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This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.
This study will assess the safety, reactogenicity, immunogenicity and persistence of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A [high dose (HD) or low dose (LD)] given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age when co-administered with Infanrix hexa™ and compared to the vaccination with Synflorix™ and with Prevnar 13™ similarly co-administered with the Infanrix hexa™ vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10PP-LD/Infanrix hexa Group | Experimental | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
|
| 10PP-HD/Infanrix hexa Group | Experimental | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
|
| Synflorix/Infanrix hexa Group | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pneumococcal vaccine GSK 2189242A (LD formulation 1) | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study | Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to [>=] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (>) 40.0°C. Primary results correspond to results for occurrences of G3 fever symptoms assessed by the investigators as related to vaccination (Related G3 fever). | Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course |
| Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group | Grade 3 fever was defined as fever by rectal measurement > 40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-LD/Infanrix hexa (or 10PP-LD) and Synflorix/Infanrix hexa (or 10PN) groups only. | During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses |
| Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group | Grade 3 fever was defined as fever by rectal measurement >40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-HD/Infanrix hexa (or 10PP-HD) and Synflorix/Infanrix hexa (or 10PN) groups only. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Primary Phase of the Study | Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Primary Phase of the study. |
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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 | Benešov | 256 01 | Czechia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28729019 | Background | Prymula R, Szenborn L, Silfverdal SA, Wysocki J, Albrecht P, Traskine M, Gardev A, Song Y, Borys D. Safety, reactogenicity and immunogenicity of two investigational pneumococcal protein-based vaccines: Results from a randomized phase II study in infants. Vaccine. 2017 Aug 16;35(35 Pt B):4603-4611. doi: 10.1016/j.vaccine.2017.07.008. Epub 2017 Jul 17. |
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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
The study duration is approximately 10 to 14 months depending on age at recruitment and age at booster vaccination. 2 Phases in the study: Primary Phase when subjects received a 3-dose of pneumococcal vaccine co-administered with Infanrix hexa™ (Months 0, 1, 2), and Booster Phase when subjects received one dose of the same vaccines (Month 10).
A total of 576 subjects were initially enrolled in the study. Of these, one subject was older than protocol defined age range for the first vaccination, and therefore did not receive any vaccination.
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| ID | Title | Description |
|---|---|---|
| FG000 | 10PP-LD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Phase |
|
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This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
|
| Prevnar 13/Infanrix hexa Group | Active Comparator | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
|
| Pneumococcal vaccine GSK 2189242A (HD formulation 2) | Biological | Intramuscular injection |
|
|
| Synflorix | Biological | Intramuscular injection |
|
| Prevenar 13 | Biological | Intramuscular injection |
|
| Infanrix Hexa (DTPa-HBV-IPV/Hib) | Biological | Intramuscular injection |
|
| During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses |
| At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Booster Phase of the Study | Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Booster Phase of the study. | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Antibody Concentrations Against Protein D (Anti-PD) - Primary Phase of the Study | Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Primary Phase of the study. | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Antibody Concentrations Against Protein D (Anti-PD) - Booster Phase of the Study | Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Booster Phase of the study. | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study | Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. This outcome concerns results for the Primary Phase of the study. | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study | Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns results for the Booster Phase of the study. | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Primary Phase of the study. | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Booster Phase of the study. | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Primary Phase of the Study | Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Primary Phase of the study. | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Booster Phase of the Study | Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Booster Phase of the study. | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Primary Phase of the Study | Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Primary Phase of the study. | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Booster Phase of the Study | Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Booster Phase of the study. | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Primary Phase of the Study | Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the primary Phase of the study. | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study | Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the Booster Phase of the study. | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Primary Phase of the Study | Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Primary Phase of the study. Note that the percentage of subjects with concentration ≥10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Booster Phase of the Study | Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Booster Phase of the study. * A decrease in the specificity of the anti-HB Enzyme-Linked ImmunoSorbent Assay (ELISA) assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete reanalysis. The retest has been performed in using Food and Drug Administration (FDA)-approved ChemiLuminescence ImmunoAssay (CLIA) commercial assay Centaur™. | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Primary Phase of the Study | Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Primary Phase of the study. | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Booster Phase of the Study | Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Booster Phase of the study. | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Primary Phase of the Study | Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study. | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study | Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study. | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study | Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). | Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study | Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). | Within the 7-day (Days 0-6) period after booster vaccination |
| Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study | Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Axillary temperature higher than (>) 40.0°C. | Within the 7-day (Days 0-6) period post vaccination after booster vaccination |
| Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Phase of the Study | An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. | Within the 31-day (Days 0-30) period post primary vaccination, across doses |
| Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Phase of the Study | An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. | Within the 31-day (Days 0-30) period post booster vaccination |
| Number of Subjects With Serious Adverse Events (SAEs) | An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination. | During the entire study period (Months 0-11) |
| Brno |
| 613 00 |
| Czechia |
| GSK Investigational Site | Děčín | 405 01 | Czechia |
| GSK Investigational Site | Jindřichův Hradec | 37701 | Czechia |
| GSK Investigational Site | Kladno | 272 01 | Czechia |
| GSK Investigational Site | Liberec | 46015 | Czechia |
| GSK Investigational Site | Náchod | 547 01 | Czechia |
| GSK Investigational Site | Ostrov | 363 01 | Czechia |
| GSK Investigational Site | Pardubice | 532 03 | Czechia |
| GSK Investigational Site | Prague | 1600 | Czechia |
| GSK Investigational Site | Schwäbisch Hall | Baden-Wurttemberg | 74523 | Germany |
| GSK Investigational Site | Tuttlingen | Baden-Wurttemberg | 78532 | Germany |
| GSK Investigational Site | Detmold | North Rhine-Westphalia | 32756 | Germany |
| GSK Investigational Site | Frankenthal | Rhineland-Palatinate | 67227 | Germany |
| GSK Investigational Site | Berlin | 13055 | Germany |
| GSK Investigational Site | Dębica | 39-200 | Poland |
| GSK Investigational Site | Krakow | 31-503 | Poland |
| GSK Investigational Site | Poznan | 61-709 | Poland |
| GSK Investigational Site | Siemianowice Śląskie | 41-103 | Poland |
| GSK Investigational Site | Warsaw | 01-184 | Poland |
| GSK Investigational Site | Wroclaw | 50345 | Poland |
| GSK Investigational Site | Örebro | SE-702 11 | Sweden |
| GSK Investigational Site | Östersund | SE-831 83 | Sweden |
| GSK Investigational Site | Umeå | SE-901 85 | Sweden |
| FG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| FG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| FG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
| COMPLETED |
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| NOT COMPLETED |
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| Booster Phase |
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| ID | Title | Description |
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| BG000 | 10PP-LD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| BG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| BG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| BG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
| BG004 | 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 | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Weeks |
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| 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 Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study | Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to [>=] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (>) 40.0°C. Primary results correspond to results for occurrences of G3 fever symptoms assessed by the investigators as related to vaccination (Related G3 fever). | The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available. | Posted | Count of Participants | Participants | Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course |
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| Primary | Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group | Grade 3 fever was defined as fever by rectal measurement > 40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-LD/Infanrix hexa (or 10PP-LD) and Synflorix/Infanrix hexa (or 10PN) groups only. | The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available. | Posted | Number | Percentage of participants | During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses |
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| Primary | Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group | Grade 3 fever was defined as fever by rectal measurement >40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-HD/Infanrix hexa (or 10PP-HD) and Synflorix/Infanrix hexa (or 10PN) groups only. | The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available. | Posted | Number | Percentage of participants | During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses |
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| Secondary | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Primary Phase of the Study | Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Primary Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Booster Phase of the Study | Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Booster Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Antibody Concentrations Against Protein D (Anti-PD) - Primary Phase of the Study | Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Primary Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Antibody Concentrations Against Protein D (Anti-PD) - Booster Phase of the Study | Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Booster Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study | Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. This outcome concerns results for the Primary Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study | Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns results for the Booster Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Primary Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Booster Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Primary Phase of the Study | Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Primary Phase of the study. | This analysis could not be performed as no validated assay was available. | Posted | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Booster Phase of the Study | Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Booster Phase of the study. | This analysis could not be performed as no validated assay was available. | Posted | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Primary Phase of the Study | Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Primary Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Booster Phase of the Study | Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Booster Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | IU/mL | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Primary Phase of the Study | Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the primary Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study | Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the Booster Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Primary Phase of the Study | Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Primary Phase of the study. Note that the percentage of subjects with concentration ≥10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Booster Phase of the Study | Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Booster Phase of the study. * A decrease in the specificity of the anti-HB Enzyme-Linked ImmunoSorbent Assay (ELISA) assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete reanalysis. The retest has been performed in using Food and Drug Administration (FDA)-approved ChemiLuminescence ImmunoAssay (CLIA) commercial assay Centaur™. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Primary Phase of the Study | Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Primary Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Booster Phase of the Study | Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Booster Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | µg/mL | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Primary Phase of the Study | Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study | Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study. | The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase). | Posted | Geometric Mean | 95% Confidence Interval | Titers | At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™) |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study | Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). | The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available. | Posted | Count of Participants | Participants | Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course |
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| Secondary | Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study | Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm). | The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available. | Posted | Count of Participants | Participants | Within the 7-day (Days 0-6) period after booster vaccination |
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| Secondary | Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study | Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Axillary temperature higher than (>) 40.0°C. | The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available. | Posted | Count of Participants | Participants | Within the 7-day (Days 0-6) period post vaccination after booster vaccination |
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| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Phase of the Study | An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. | The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases. | Posted | Count of Participants | Participants | Within the 31-day (Days 0-30) period post primary vaccination, across doses |
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| Secondary | Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Phase of the Study | An unsolicited AE was defined as 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. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. | The analysis was performed on the Total Vaccinated cohort of Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases. | Posted | Count of Participants | Participants | Within the 31-day (Days 0-30) period post booster vaccination |
| |||||||||||||||||||||||||||||
| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination. | The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases. | Posted | Count of Participants | Participants | During the entire study period (Months 0-11) |
|
Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
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 | 10PP-LD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. | 0 | 146 | 13 | 146 | 141 | 146 |
| EG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. | 0 | 142 | 9 | 142 | 137 | 142 |
| EG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. | 0 | 145 | 21 | 145 | 139 | 145 |
| EG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. | 0 | 142 | 17 | 142 | 134 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis rotavirus | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bacterial infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Febrile convulsion | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Phimosis | Congenital, familial and genetic disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Psychomotor retardation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Accidental exposure to product by child | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Breath holding | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Exanthema subitum | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis Escherichia coli | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotonic-hyporesponsive episode | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Localised oedema | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Rectal fissure | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Type 1 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-primary vaccination periods, across doses |
|
| Redness | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-primary vaccination periods, across doses |
|
| Swelling | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-primary vaccination periods , across doses |
|
| Drowsiness | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-primary vaccination periods, across doses |
|
| Irritability | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-primary vaccination periods, across doses |
|
| Loss of appetite | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-primary vaccination periods, across doses |
|
| Fever (rectal temperature >= 38°C) | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-primary vaccination periods, across doses |
|
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-booster vaccination period |
|
| Redness | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-booster vaccination period |
|
| Swelling | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-booster vaccination period |
|
| Drowsiness | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-booster vaccination period |
|
| Irritability | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-booster vaccination period |
|
| Loss of appetite | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-booster vaccination period |
|
| Fever (rectal temperature >= 38°C) | General disorders | MedDRA 18.1 | Systematic Assessment | Symptom reported during the 7-day post-booster vaccination period |
|
| Conjunctivitis | Eye disorders | MedDRA 18.1 | Systematic Assessment | Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses |
|
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment | Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment | Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment | Unsolicited AE reported during the 31-day post-booster vaccination period |
|
| Rhinitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment | Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses |
|
| Viral infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment | Unsolicited AE reported during the 31-day post-primary vaccination periods, across doses |
|
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 |
| D006192 | Haemophilus Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D016871 | Pasteurellaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| C547294 | PHiD-CV vaccine |
| C538862 | 13-valent pneumococcal vaccine |
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
Not provided
Not provided
Not provided
| Male |
|
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
|
| G3 Drowsiness, post D1 |
|
|
| Related Drowsiness, post D1 |
|
|
| Any Irritability, post D1 |
|
|
| G3 Irritability, post D1 |
|
|
| Related Irritability, post D1 |
|
|
| Any Loss Appet., post D1 |
|
|
| G3 Loss Appet., post D1 |
|
|
| Related Loss Appet., post D1 |
|
|
| Any Fever, post D1 |
|
|
| G3 Fever, post D1 |
|
|
| Related Fever, post D1 |
|
|
| Related G3 Fever, post D1 |
|
|
| Any Drowsiness, post D2 |
|
|
| G3 Drowsiness, post D2 |
|
|
| Related Drowsiness, post D2 |
|
|
| Any Irritability, post D2 |
|
|
| G3 Irritability, post D2 |
|
|
| Related Irritability, post D2 |
|
|
| Any Loss Appet., post D2 |
|
|
| G3 Loss Appet., post D2 |
|
|
| Related Loss Appet., post D2 |
|
|
| Any Fever, post D2 |
|
|
| G3 Fever, post D2 |
|
|
| Related Fever, post D2 |
|
|
| Related G3 Fever, post D2 |
|
|
| Any Drowsiness, post D3 |
|
|
| Grade 3 Drowsiness, post D3 |
|
|
| Related Drowsiness, post D3 |
|
|
| Any Irritability, post D3 |
|
|
| G3 Irritability, post D3 |
|
|
| Related Irritability, post D3 |
|
|
| Any Loss Appet., post D3 |
|
|
| G3 Loss Appet., post D3 |
|
|
| Related Loss Appet., post D3 |
|
|
| Any Fever, post D3 |
|
|
| G3 Fever, post D3 |
|
|
| Related Fever, post D3 |
|
|
| Related G3 Fever, post D3 |
|
|
| OG001 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
|
|
|
| OG001 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
|
|
|
| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
|
|
| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
|
|
| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
|
|
| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
|
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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|
| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
|
|
| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
|
|
| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
|
|
| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
|
|
| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
|
|
| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
|
|
| OG001 | 10PP-HD/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. |
| OG002 | Synflorix/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. |
| OG003 | Prevnar 13/Infanrix Hexa Group | This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. |
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