| Primary | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported. | The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in. | Posted | | Count of Participants | | Participants | | Within 31-day (Day 0-Day 30) after any dose of primary vaccination | | | | ID | Title | Description |
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| OG000 | Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | | OG001 | Prevnar 1 Group | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. | | OG002 | Prevnar 2 Group | Subjects who were primed with two doses of Prevnar 13 vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. |
| | | Title | Denominators | Categories |
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| Any AEs Dose 1 | - ParticipantsOG00090
- ParticipantsOG00194
- ParticipantsOG00294
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity. | The analysis was performed on The Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period following each primary dose | | | | ID | Title | Description |
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| OG000 | Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | | OG001 | Prevnar 1 Group | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity. | The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-booster vaccination period | | | | ID | Title | Description |
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| OG000 | Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | | OG001 | Prevnar 1 Group | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. | |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. | The analysis was performed on The Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented and the symptom sheet filled in. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-vaccination period following each primary dose | | | | ID | Title | Description |
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| OG000 | Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | | OG001 | Prevnar 1 Group | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. |
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| Secondary | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Solicited general symptoms assessed include drowsiness, fever (defined as axillary temperature ≥ 37.5°C), irritability, and loss of appetite. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (axillary temperature) above (>) 39.5 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination. | The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in. | Posted | | Count of Participants | | Participants | | During the 4-day (Days 0-3) post-booster vaccination period | | | | ID | Title | Description |
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| OG000 | Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | | OG001 | Prevnar 1 Group | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. |
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| Secondary | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported. | The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented and the symptom sheet filled in. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) post-booster vaccination period | | | | ID | Title | Description |
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| OG000 | Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | | OG001 | Prevnar 1 Group | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. | | OG002 | Prevnar 2 Group | |
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| Secondary | Number of Subjects With Unsolicited AEs - Primary Period | An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. | The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) post-primary vaccination period | | | | ID | Title | Description |
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| OG000 | Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | | OG001 | Prevnar 1 Group | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. | | OG002 |
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| Secondary | Number of Subjects With Unsolicited AEs - Booster Period | An unsolicited AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. | The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented. | Posted | | Count of Participants | | Participants | | During the 31-day (Days 0-30) post-booster vaccination period | | | | ID | Title | Description |
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| OG000 | Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | | OG001 | Prevnar 1 Group | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. | | OG002 |
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| Secondary | Number of Subjects With Serious Adverse Events (SAEs) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. | The analysis was performed on the Total Vaccinated cohort for Primary Epoch, which included all subjects with at least one primary vaccine dose administration documented. | Posted | | Count of Participants | | Participants | | From first vaccination (Month 0) up to study end (11-14 months) | | | | ID | Title | Description |
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| OG000 | Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | | OG001 | Prevnar 1 Group | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. | | OG002 | Prevnar 2 Group | |
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| Secondary | Antibody Concentrations Against Pneumococcal Serotypes | 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-inhibition enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. | The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | µg/mL | | At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination) | | | | ID | Title | Description |
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| OG000 | Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | | OG001 | Prevnar 1 Group | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. |
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| Secondary | Concentrations of Antibodies Against Protein D (Anti-PD) | Anti-PD 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 cut-off of the assay was an anti-PD antibody concentration higher than or equal to (≥) 153 EL.U/mL. | The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available. | Posted | | Geometric Mean | 95% Confidence Interval | EL.U/mL | | At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination) | | | | ID | Title | Description |
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| OG000 | Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. | | OG001 | Prevnar 1 Group | Subjects who were primed with Prevnar 13 and Synflorix vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age. |
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| Secondary | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | The immunogenicity assessment was based on multiplex opsonophagocytic activity assay (MOPA). Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against 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 cut-off of the assay was a serotype specific titer for opsonophagocytic activity higher than or equal to (≥) the Lower Limit of Quantification (LLOQ) i.e.: 14 for OPA-1, 11 for OPA-3; 40 for OPA-4; 15 for OPA-5; 45 for OPA-6A; 29 for OPA-6B; 28 for OPA-7F; 39 for OPA-9V; 16 for OPA-14; 40 for OPA-18C; 13 for OPA-19A; 33 for OPA-19F and 40 for OPA-23F. | The analysis was performed on the ATP cohort for immunogenicity adapted for each epoch, which included all evaluable subjects for whom data concerning primary or booster immunogenicity outcome measures were available. OPA testing was performed on a random subset of 50% per group. | Posted | | Geometric Mean | 95% Confidence Interval | Titers | | At study Month 3 (one month after the primary vaccination), at study Month 10 (prior to booster vaccination) and at study Month 11 (one month after the booster vaccination) | | | | ID | Title | Description |
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| OG000 | Synflorix Group | Subjects who were primed with two doses of Synflorix vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age. |
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