Infections, Streptococcal, Streptococcus Pneumoniae Vaccines
Conditions
Keywords
pneumococcal conjugate vaccine, Synflorix, Prevnar 13, Pneumococcal diseases
Brief summary
The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.
Detailed description
This study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.
Interventions
BIOLOGICALSynflorix (3-Dose)
3 doses administered intramuscularly
BIOLOGICALSynflorix (2-Dose)
2 doses administered intramuscularly
BIOLOGICALSynflorix (Single Dose)
1 dose administered intramuscularly
BIOLOGICALPrevenar 13 (Single Dose)
1 dose administered intramuscularly
BIOLOGICALPrevenar 13 (2-Dose)
2 doses administered intramuscularly
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol. * A male or female between, and including, 6-12 weeks of age at the time of the first vaccination. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Born after a gestation period of at least 36 weeks. * Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine. * Major congenital defects or serious chronic illness. * History of any seizures or progressive neurological disease. * Administration of immunoglobulins and/or blood products since birth or planned use during the study. * Acute disease and/or fever at the time of enrolment. * Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Within 31-day (Day 0-Day 30) after any dose of primary vaccination | The number of subjects with Grade 3 AEs (solicited and unsolicited), during the 31-day post-vaccination period following each primary dose is reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | During the 4-day (Days 0-3) post-booster vaccination 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. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | During the 4-day (Days 0-3) post-vaccination period following each primary dose | 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. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | During the 4-day (Days 0-3) post-booster vaccination 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. |
| Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | During the 31-day (Days 0-30) post-booster vaccination period | The number of subjects with any and grade 3 symptoms (solicited and unsolicited), during the 31-day post-booster vaccination period is reported. |
| Number of Subjects With Unsolicited AEs - Primary Period | During the 31-day (Days 0-30) post-primary vaccination 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. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | During the 4-day (Days 0-3) post-vaccination period following each primary dose | 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. |
| Number of Subjects With Serious Adverse Events (SAEs) | From first vaccination (Month 0) up to study end (11-14 months) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Antibody Concentrations Against Pneumococcal Serotypes | 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) | 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. |
| Concentrations of Antibodies Against Protein D (Anti-PD) | At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination) | 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. |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | 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) | 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. |
| Number of Subjects With Unsolicited AEs - Booster Period | During the 31-day (Days 0-30) post-booster vaccination 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. |
Countries
Mexico
Participant flow
Pre-assignment details
457 subjects were enrolled in the study. Of these, 5 subjects were not included in the Total Vaccinated Cohort, as the study vaccine was not administered. In addition, 157 subjects enrolled at one center were excluded from analysis because of GCP deficiencies, and 1 subject from another center because of invalid Informed Consent form.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 97 |
| 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. | 99 |
| 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. | 98 |
| Total | 294 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 2 | 2 |
| Overall Study | Migrated/moved from study area | 5 | 3 | 1 |
| Overall Study | Protocol Violation | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 3 | 3 |
Baseline characteristics
| Characteristic | Synflorix Group | Prevnar 1 Group | Prevnar 2 Group | Total |
|---|---|---|---|---|
| Age, Continuous | 7.4 Weeks STANDARD_DEVIATION 1.3 | 7.4 Weeks STANDARD_DEVIATION 1.5 | 7.4 Weeks STANDARD_DEVIATION 1.6 | 7.4 Weeks STANDARD_DEVIATION 1.47 |
| Sex: Female, Male Female | 55 Participants | 47 Participants | 53 Participants | 155 Participants |
| Sex: Female, Male Male | 42 Participants | 52 Participants | 45 Participants | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 99 | 0 / 98 |
| other Total, other adverse events | 85 / 97 | 88 / 99 | 86 / 98 |
| serious Total, serious adverse events | 3 / 97 | 4 / 99 | 1 / 98 |
Outcome results
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.
Time frame: Within 31-day (Day 0-Day 30) after any dose of primary vaccination
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Any AEs Dose 1 | 18 Participants |
| Synflorix Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Any AEs Dose 2 | 12 Participants |
| Synflorix Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | General AEs Dose 1 | 5 Participants |
| Synflorix Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | General AEs Dose 2 | 8 Participants |
| Synflorix Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Local AEs Dose 1 | 17 Participants |
| Synflorix Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Local AEs Dose 2 | 7 Participants |
| Prevnar 1 Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Local AEs Dose 2 | 9 Participants |
| Prevnar 1 Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Any AEs Dose 1 | 10 Participants |
| Prevnar 1 Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | General AEs Dose 2 | 4 Participants |
| Prevnar 1 Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Local AEs Dose 1 | 8 Participants |
| Prevnar 1 Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Any AEs Dose 2 | 11 Participants |
| Prevnar 1 Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | General AEs Dose 1 | 3 Participants |
| Prevnar 2 Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Any AEs Dose 2 | 6 Participants |
| Prevnar 2 Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | General AEs Dose 1 | 2 Participants |
| Prevnar 2 Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Local AEs Dose 2 | 4 Participants |
| Prevnar 2 Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | General AEs Dose 2 | 2 Participants |
| Prevnar 2 Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Any AEs Dose 1 | 10 Participants |
| Prevnar 2 Group | Number of Subjects With Grade 3 Adverse Events (AEs) (Solicited and Unsolicited) - Primary Period | Local AEs Dose 1 | 9 Participants |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6A Month 10 | 0.25 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F Month 10 | 1.19 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14 Month 11 | 10.04 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6A Month 11 | 1.3 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-3 Month 11 | 0.1 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14 Month 10 | 1.15 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B Month 3 | 0.96 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1 Month 11 | 4.61 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14 Month 3 | 4.74 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B Month 10 | 0.48 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F Month 3 | 4.62 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V Month 11 | 7.04 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B Month 11 | 3.53 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4 Month 3 | 3.54 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V Month 10 | 0.86 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F Month 3 | 3.36 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1 Month 10 | 0.34 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V Month 3 | 2.67 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F Month 10 | 1.16 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19A Month 11 | 1.64 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F Month 11 | 7.63 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4 Month 10 | 0.57 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F Month 3 | 1.43 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19A Month 10 | 0.19 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4 Month 11 | 6.76 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-3 Month 3 | 0.06 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19A Month 3 | 0.24 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5 Month 3 | 4.55 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F Month 11 | 4.16 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1 Month 3 | 2.74 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5 Month 10 | 0.96 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F Month 11 | 14.43 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C Month 11 | 25.18 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5 Month 11 | 8.31 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-3 Month 10 | 0.09 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C Month 10 | 0.81 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6A Month 3 | 0.22 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F Month 10 | 0.53 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C Month 3 | 3.3 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C Month 11 | 19.39 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1 Month 3 | 3.12 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1 Month 10 | 0.53 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1 Month 11 | 4.2 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-3 Month 3 | 0.84 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-3 Month 10 | 0.21 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-3 Month 11 | 0.21 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4 Month 3 | 2.73 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4 Month 10 | 0.56 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4 Month 11 | 4.7 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5 Month 3 | 2.59 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5 Month 10 | 0.77 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5 Month 11 | 5.27 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6A Month 3 | 0.36 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6A Month 10 | 0.28 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6A Month 11 | 0.93 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B Month 3 | 0.21 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B Month 10 | 0.3 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B Month 11 | 1.92 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F Month 3 | 2.74 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F Month 10 | 1 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F Month 11 | 5.07 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V Month 3 | 1.34 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V Month 10 | 0.49 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V Month 11 | 2.48 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14 Month 3 | 3.45 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14 Month 10 | 1.05 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14 Month 11 | 8.1 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C Month 3 | 3.22 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C Month 10 | 0.65 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19A Month 3 | 0.72 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19A Month 10 | 0.36 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19A Month 11 | 1.67 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F Month 3 | 5.67 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F Month 10 | 1.39 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F Month 11 | 13.57 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F Month 3 | 0.53 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F Month 10 | 0.24 µg/mL |
| Prevnar 1 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F Month 11 | 1.76 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6A Month 10 | 0.67 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-3 Month 3 | 2.48 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14 Month 11 | 7.62 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6A Month 3 | 3.35 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F Month 10 | 0.36 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C Month 3 | 3.24 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5 Month 11 | 6.15 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F Month 11 | 13.81 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C Month 10 | 0.56 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5 Month 10 | 1.05 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-5 Month 3 | 4.89 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-18C Month 11 | 19.27 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4 Month 11 | 8.77 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1 Month 11 | 5.22 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19A Month 3 | 2.43 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4 Month 10 | 0.39 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1 Month 3 | 4 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19A Month 10 | 0.34 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-4 Month 3 | 2.74 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F Month 3 | 1.74 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19A Month 11 | 2.17 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F Month 10 | 1.24 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-3 Month 11 | 0.33 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F Month 11 | 5.83 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-7F Month 3 | 4.83 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-1 Month 10 | 0.62 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V Month 3 | 2.96 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B Month 11 | 3.03 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F Month 3 | 4.17 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V Month 10 | 0.53 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B Month 10 | 0.24 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-3 Month 10 | 0.37 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-9V Month 11 | 2.84 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6B Month 3 | 0.38 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-23F Month 11 | 2.76 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14 Month 3 | 4.99 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-6A Month 11 | 1.97 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-19F Month 10 | 0.53 µg/mL |
| Prevnar 2 Group | Antibody Concentrations Against Pneumococcal Serotypes | Anti-14 Month 10 | 1.78 µg/mL |
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.
Time frame: At study Month 3 (one month after primary vaccination) and at study Month 11 (one month after booster vaccination)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Concentrations of Antibodies Against Protein D (Anti-PD) | Anti-PD Month 3 (N=45,50,37) | 2025.1 EL.U/mL |
| Synflorix Group | Concentrations of Antibodies Against Protein D (Anti-PD) | Anti-PD Month 11 (N=45,42,37) | 3658.5 EL.U/mL |
| Prevnar 1 Group | Concentrations of Antibodies Against Protein D (Anti-PD) | Anti-PD Month 3 (N=45,50,37) | 117.2 EL.U/mL |
| Prevnar 1 Group | Concentrations of Antibodies Against Protein D (Anti-PD) | Anti-PD Month 11 (N=45,42,37) | 791 EL.U/mL |
| Prevnar 2 Group | Concentrations of Antibodies Against Protein D (Anti-PD) | Anti-PD Month 3 (N=45,50,37) | 143.2 EL.U/mL |
| Prevnar 2 Group | Concentrations of Antibodies Against Protein D (Anti-PD) | Anti-PD Month 11 (N=45,42,37) | 219.7 EL.U/mL |
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.
Time frame: During the 4-day (Days 0-3) post-booster vaccination period
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Any Swelling | 12 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Any Redness | 20 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Grade 3 Swelling | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Any Pain | 44 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Grade 3 Redness | 4 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Grade 3 Pain | 2 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Grade 3 Redness | 2 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Any Swelling | 14 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Grade 3 Swelling | 3 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Grade 3 Pain | 6 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Any Pain | 44 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Any Redness | 10 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Grade 3 Swelling | 4 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Any Pain | 45 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Grade 3 Pain | 9 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Any Redness | 17 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Grade 3 Redness | 3 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Booster Period | Any Swelling | 19 Participants |
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.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each primary dose
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Pain Dose 1 | 61 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Pain Dose 1 | 14 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Redness Dose 1 | 9 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Redness Dose 1 | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Swelling Dose 1 | 16 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Swelling Dose 1 | 3 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Pain Dose 2 | 48 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Pain Dose 2 | 6 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Redness Dose 2 | 5 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Redness Dose 2 | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Swelling Dose 2 | 5 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Swelling Dose 2 | 0 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Swelling Dose 2 | 0 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Pain Dose 1 | 49 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Pain Dose 2 | 49 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Redness Dose 2 | 9 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Pain Dose 1 | 8 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Swelling Dose 1 | 0 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Swelling Dose 2 | 9 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Redness Dose 1 | 11 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Pain Dose 2 | 9 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Swelling Dose 1 | 12 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Redness Dose 1 | 0 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Redness Dose 2 | 0 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Redness Dose 1 | 0 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Swelling Dose 1 | 10 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Redness Dose 2 | 0 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Swelling Dose 1 | 0 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Pain Dose 2 | 42 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Pain Dose 2 | 4 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Swelling Dose 2 | 11 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Pain Dose 1 | 55 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Pain Dose 1 | 9 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Redness Dose 2 | 12 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Any Redness Dose 1 | 7 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms - Primary Period | Grade 3 Swelling Dose 2 | 1 Participants |
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.
Time frame: During the 31-day (Days 0-30) post-booster vaccination period
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Any symptom | 66 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Any Grade 3 symptom | 10 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | General symptom | 57 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Grade 3 general symptom | 4 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Local symptom | 50 Participants |
| Synflorix Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Grade 3 local symptom | 6 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Grade 3 local symptom | 9 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Any symptom | 70 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Grade 3 general symptom | 5 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Local symptom | 47 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Any Grade 3 symptom | 12 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | General symptom | 66 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Any Grade 3 symptom | 14 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | General symptom | 61 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Grade 3 local symptom | 13 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Grade 3 general symptom | 4 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Any symptom | 67 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any and Grade 3 Symptoms (Solicited and Unsolicited) - Booster Period | Local symptom | 47 Participants |
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.
Time frame: During the 4-day (Days 0-3) post-booster vaccination period
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Any Drowsiness | 25 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Grade 3 Drowsiness | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Related Drowsiness | 25 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Any Irritability | 33 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Grade 3 Irritability | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Related Irritability | 33 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Any Loss of appetite | 24 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Grade 3 Loss of appetite | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Related Loss of appetite | 22 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Any Fever | 9 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Grade 3 Fever | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Related Fever | 9 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Related Fever | 8 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Any Drowsiness | 27 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Any Loss of appetite | 22 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Related Loss of appetite | 21 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Grade 3 Drowsiness | 0 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Related Irritability | 36 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Grade 3 Fever | 0 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Related Drowsiness | 24 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Grade 3 Loss of appetite | 1 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Grade 3 Irritability | 2 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Any Irritability | 39 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Any Fever | 11 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Any Irritability | 45 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Grade 3 Irritability | 3 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Any Fever | 11 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Related Irritability | 44 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Any Loss of appetite | 17 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Grade 3 Loss of appetite | 0 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Grade 3 Fever | 0 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Any Drowsiness | 26 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Grade 3 Drowsiness | 3 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Related Loss of appetite | 17 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Related Drowsiness | 26 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Booster Period | Related Fever | 10 Participants |
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.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each primary dose
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Loss of appetite Dose 1 | 21 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Drowsiness Dose 1 | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Drowsiness Dose 1 | 35 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Irritability Dose 1 | 48 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Irritability Dose 1 | 5 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Irritability Dose 1 | 46 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Drowsiness Dose 1 | 35 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Loss of appetite Dose 1 | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Loss of appetite Dose 1 | 20 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Fever Dose 1 | 18 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Fever Dose 1 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Fever Dose 1 | 17 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Drowsiness Dose 2 | 27 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Drowsiness Dose 2 | 1 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Drowsiness Dose 2 | 25 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Irritability Dose 2 | 39 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Irritability Dose 2 | 4 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Irritability Dose 2 | 37 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Loss of appetite Dose 2 | 12 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Loss of appetite Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Loss of appetite Dose 2 | 12 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Fever Dose 2 | 15 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Fever Dose 2 | 0 Participants |
| Synflorix Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Fever Dose 2 | 15 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Fever Dose 2 | 14 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Drowsiness Dose 1 | 36 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Drowsiness Dose 2 | 24 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Irritability Dose 2 | 1 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Drowsiness Dose 1 | 1 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Fever Dose 1 | 0 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Loss of appetite Dose 2 | 17 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Drowsiness Dose 1 | 32 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Drowsiness Dose 2 | 1 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Fever Dose 2 | 0 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Irritability Dose 1 | 46 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Fever Dose 1 | 12 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Irritability Dose 2 | 51 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Irritability Dose 1 | 2 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Drowsiness Dose 2 | 23 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Fever Dose 1 | 11 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Irritability Dose 1 | 41 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Loss of appetite Dose 1 | 18 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Fever Dose 2 | 14 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Loss of appetite Dose 1 | 20 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Irritability Dose 2 | 52 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Loss of appetite Dose 2 | 17 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Loss of appetite Dose 1 | 0 Participants |
| Prevnar 1 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Loss of appetite Dose 2 | 0 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Loss of appetite Dose 1 | 0 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Loss of appetite Dose 1 | 16 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Fever Dose 1 | 11 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Fever Dose 1 | 0 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Loss of appetite Dose 2 | 0 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Fever Dose 1 | 10 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Fever Dose 2 | 0 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Drowsiness Dose 2 | 31 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Drowsiness Dose 2 | 0 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Loss of appetite Dose 2 | 18 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Drowsiness Dose 2 | 31 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Fever Dose 2 | 16 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Irritability Dose 2 | 41 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Drowsiness Dose 1 | 45 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Drowsiness Dose 1 | 2 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Irritability Dose 2 | 1 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Drowsiness Dose 1 | 42 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Fever Dose 2 | 17 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Irritability Dose 1 | 53 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Grade 3 Irritability Dose 1 | 2 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Irritability Dose 2 | 39 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Related Irritability Dose 1 | 49 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Loss of appetite Dose 1 | 19 Participants |
| Prevnar 2 Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms - Primary Period | Any Loss of appetite Dose 2 | 19 Participants |
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.
Time frame: From first vaccination (Month 0) up to study end (11-14 months)
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| Prevnar 1 Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
| Prevnar 2 Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
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.
Time frame: During the 31-day (Days 0-30) post-booster vaccination period
Population: The analysis was performed on the Total Vaccinated cohort for Booster Epoch, which included all subjects with booster vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Group | Number of Subjects With Unsolicited AEs - Booster Period | 25 Participants |
| Prevnar 1 Group | Number of Subjects With Unsolicited AEs - Booster Period | 27 Participants |
| Prevnar 2 Group | Number of Subjects With Unsolicited AEs - Booster Period | 28 Participants |
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.
Time frame: During the 31-day (Days 0-30) post-primary vaccination period
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Group | Number of Subjects With Unsolicited AEs - Primary Period | 55 Participants |
| Prevnar 1 Group | Number of Subjects With Unsolicited AEs - Primary Period | 58 Participants |
| Prevnar 2 Group | Number of Subjects With Unsolicited AEs - Primary Period | 61 Participants |
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.
Time frame: 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)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6A Month 10 | 96.1 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19F Month 10 | 127.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-14 Month 11 | 3132.1 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6A Month 11 | 480.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-3 Month 11 | 11.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-14 Month 10 | 303.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6B Month 3 | 603.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-1 Month 11 | 311.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-14 Month 3 | 1497.1 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6B Month 10 | 182.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19F Month 3 | 1306.1 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-9V Month 11 | 5130.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6B Month 11 | 1868.1 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-4 Month 3 | 1327.9 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-9V Month 10 | 424.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-7F Month 3 | 2595.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-1 Month 10 | 10.3 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-9V Month 3 | 1904.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-7F Month 10 | 654.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19A Month 11 | 748.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-7F Month 11 | 3557.9 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-4 Month 10 | 128.1 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-23F Month 3 | 633.3 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19A Month 10 | 37.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-4 Month 11 | 2729.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-3 Month 3 | 5.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19A Month 3 | 85.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-5 Month 3 | 335.9 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-23F Month 11 | 1500.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-1 Month 3 | 58.9 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-5 Month 10 | 68.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19F Month 11 | 2900.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-18C Month 11 | 6271.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-5 Month 11 | 669.2 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-3 Month 10 | 18.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-18C Month 10 | 116.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6A Month 3 | 60.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-23F Month 10 | 234.9 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-18C Month 3 | 965.3 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-18C Month 11 | 4731.5 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-1 Month 3 | 51.5 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-1 Month 10 | 8.8 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-1 Month 11 | 139.3 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-3 Month 3 | 50.5 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-3 Month 10 | 33.2 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-3 Month 11 | 22.7 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-4 Month 3 | 812.1 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-4 Month 10 | 123.5 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-4 Month 11 | 1583.4 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-5 Month 3 | 132.0 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-5 Month 10 | 29.3 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-5 Month 11 | 266.2 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6A Month 3 | 91.9 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6A Month 10 | 73.5 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6A Month 11 | 216.8 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6B Month 3 | 107.4 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6B Month 10 | 131.3 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6B Month 11 | 958.5 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-7F Month 3 | 1702.1 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-7F Month 10 | 676.6 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-7F Month 11 | 2337.9 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-9V Month 3 | 1141.6 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-9V Month 10 | 441.3 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-9V Month 11 | 2391.0 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-14 Month 3 | 924.2 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-14 Month 10 | 270.2 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-14 Month 11 | 2043.1 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-18C Month 3 | 685.5 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-18C Month 10 | 72.3 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19A Month 3 | 173.4 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19A Month 10 | 71.7 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19A Month 11 | 642.2 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19F Month 3 | 1492.8 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19F Month 10 | 158.8 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19F Month 11 | 2749.9 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-23F Month 3 | 143.9 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-23F Month 10 | 199.1 Titers |
| Prevnar 1 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-23F Month 11 | 1005.7 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6A Month 10 | 112.1 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-3 Month 3 | 190.7 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-14 Month 11 | 1413.9 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6A Month 3 | 1185.5 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-23F Month 10 | 164.3 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-18C Month 3 | 1114.7 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-5 Month 11 | 379.4 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19F Month 11 | 3696.9 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-18C Month 10 | 61.8 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-5 Month 10 | 37.3 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-5 Month 3 | 250.2 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-18C Month 11 | 4358.6 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-4 Month 11 | 3033.2 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-1 Month 11 | 240.3 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19A Month 3 | 677.2 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-4 Month 10 | 91.4 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-1 Month 3 | 96.4 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19A Month 10 | 69.5 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-4 Month 3 | 1391.5 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-23F Month 3 | 1089.4 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19A Month 11 | 1061.6 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-7F Month 10 | 858.3 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-3 Month 11 | 29.7 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-7F Month 11 | 2178.5 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-7F Month 3 | 4654.8 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-1 Month 10 | 9.4 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-9V Month 3 | 2916.6 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6B Month 11 | 1202.2 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19F Month 3 | 842.3 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-9V Month 10 | 353.9 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6B Month 10 | 60.1 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-3 Month 10 | 41.3 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-9V Month 11 | 1720.7 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6B Month 3 | 331.6 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-23F Month 11 | 1097.8 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-14 Month 3 | 1391.5 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-6A Month 11 | 363.5 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-19F Month 10 | 42.0 Titers |
| Prevnar 2 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes | OPA-14 Month 10 | 342.3 Titers |