Infections, Streptococcal
Conditions
Keywords
Streptococcus pneumoniae, Haemophilus influenzae, Pneumococcal vaccine, Infants, Safety, Immunogenicity
Brief summary
The purpose of this study is to assess the immunogenicity, reactogenicity and safety of two formulations of GSK Biologicals' pneumococcal vaccine (2830929A and 2830930A) administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine will be co-administered in infants with the pneumococcal study vaccines.
Detailed description
The purpose of this study is to assess the immunogenicity of the two formulations of GSK Biologicals' pneumococcal vaccine 2830929A (11-valent vaccine or 11Pn vaccine) and 2830930A (12-valent vaccine or 12Pn vaccine), when administered as 3-dose primary vaccination during the first 6 months of life followed by a booster dose in the second year of life, when compared to immune responses to the licensed vaccines Synflorix™ and Prevnar 13™, and to assess the reactogenicity and safety of these two same investigational formulations when administered according to this schedule. To comply with the routine infant immunisation program, the licensed GSK Biologicals DTPa-HBV-IPV/Hib (Infanrix hexa™) vaccine will be co-administered in infants with the pneumococcal study vaccines.
Interventions
BIOLOGICALPneumococcal conjugate vaccine GSK2830929A
Intramuscular injection
BIOLOGICALPneumococcal conjugate vaccine GSK2830930A
Intramuscular injection
BIOLOGICALSynflorix™
Intramuscular injection
BIOLOGICALPrevnar 13™
Intramuscular injection
BIOLOGICALInfanrix hexa™
Intramuscular injection
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LARs) can and will comply with the requirements of the protocol. * A male or female between, and including 6 to 12 weeks (42-90 days) of age at the time of the first vaccination. In addition, the first pneumococcal and DTPa-HBV-IPV/Hib vaccination should be given in accordance with the official national recommendations for the immunisation schedule of infants. * Written informed consent obtained from the parents/LAR(s) of the subject. * 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.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs since birth. * Planned administration/administration of a vaccine containing diphtheria toxoid, tetanus toxoid (except MenC-TT in Spain) or CRM197 and not foreseen by the study protocol during any time of the study period, or of any other vaccines not foreseen by the protocol in the period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the following exceptions: * Licensed influenza vaccines are always allowed, even if concomitantly administered with the study vaccines. * Licensed rotavirus vaccines are allowed if administered at least 7 days before or after each dose of study of vaccines. * Licensed MenC-TT vaccine is allowed in Spain and should be concomitantly administered with the study vaccine at around 2, 4 and 12-15 months of age. * In case an emergency mass vaccination for an unforeseen public health threat (e.g. a pandemic) is organised by the public health authorities, outside the routine immunization program, that vaccine can be administered at any time during the study period provided it is licensed and used according to its Summary of Product Characteristics or Prescribing Information and according to the local governmental recommendations. * 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. * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness, including Kawasaki's syndrome. * History of any neurological disorders or seizures, including conditions such as hypotensive-hyporesponsive episodes, encephalopathy and any convulsions (afebrile and febrile). * Acute disease and/or fever at the time of enrolment. * Administration of immunoglobulins and/or any blood products since birth or planned administration during study period. * Previous vaccination against diphtheria, tetanus, pertussis, polio, H. influenzae type b. * Previous vaccination against S. pneumoniae. * History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b disease. * Any medical condition which might interfere with the assessment of the study objectives in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine | 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. Primary outcome results correspond to antibody concentrations for all serotypes presented at the exception of those for the antibodies against the cross-reactive pneumococcal serotype 3 (ANTI-3). |
| Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | 1 month post-dose 3 (primary phase) | N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA). |
| Percentage (%) of Subjects (Prevnar13 and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-19A Pneumococcal Serotype | 1 month post-dose 3 (primary phase) | N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 19A (ANTI-19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA). |
| Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | 1 month post-dose 3 (primary phase) | N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA). |
| Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes | 1 month post-dose 3 (primary phase) | N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 6A and 19A (ANTI-6A and 19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D). | Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Within the 4-day (Days 0-3) period after booster vaccination | Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm). |
| Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D). | Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \[≥\] 38.0 degrees Celsius \[°C\]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (\>) 40.0°C. |
| Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Within the 4-day (Days 0-3) period after booster vaccination | Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \[≥\] 38.0 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (\>) 40.0°C. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study | Within the 31-day (Days 0-30) period post primary vaccination, across doses | An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study | Within the 31-day (Days 0-30) period post booster vaccination | An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination. |
| Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study | From Month 0 to Month 3 | A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination. |
| Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine | Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -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. Analysis of concentrations of antibodies against the cross-reactive pneumococcal serotype 6C (ANTI-6C) will not be performed due to unavailability of a specific qualified assay. |
| Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study | At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine | Antibodies assessed for this outcome measure was that against the cross-reactive pneumococcal serotype 6A (ANTI-6A). 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. |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study | At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143). |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study | At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143). |
| Antibody Concentrations Against Pneumococcal Serotype 6C During the Primary Phase of the Study. | At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine | No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. |
| Antibody Concentrations Against Pneumococcal Serotype 6C During the Booster Phase of the Study. | At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine | No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available. |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Primary Phase of the Study | At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine | No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Booster Phase of the Study | At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine | No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available. |
| Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study | From Day 0 to Month 11 | A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination. |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay. |
| Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | At study Month 11, e.g.: at one month post booster vaccination with pneumococcal vaccine | Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay. |
| Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study | At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine | 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 (≥) 100 EL.U/mL. |
| Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study | At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine | 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 (≥) 100 EL.U/mL. |
Countries
Czechia, Germany, Poland, Spain
Participant flow
Recruitment details
953 subjects were enrolled in the study, among whom 951 received at least one dose of study vaccine, while 2 were allocated a subject number but did not receive any study vaccine dose.
Pre-assignment details
Study vaccines were administered as a 3-dose primary vaccination in healthy infants between 6-12 weeks (42-90 days) of age at the time of the first vaccination (Primary Phase), and then as an additional booster dose when subjects reached 12-15 months of age (Booster Phase).
Participants by arm
| Arm | Count |
|---|---|
| 11Pn Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate). | 240 |
| 12Pn Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate). | 240 |
| Synflorix Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate). | 230 |
| Prevnar13 Group Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ). | 241 |
| Total | 951 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 2 | 0 |
| Overall Study | Lost to Follow-up | 1 | 11 | 3 | 2 |
| Overall Study | Other reason | 0 | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 4 | 4 | 4 |
Baseline characteristics
| Characteristic | 11Pn Group | 12Pn Group | Synflorix Group | Prevnar13 Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 8.6 Weeks STANDARD_DEVIATION 1.49 | 8.7 Weeks STANDARD_DEVIATION 1.61 | 8.7 Weeks STANDARD_DEVIATION 1.62 | 8.6 Weeks STANDARD_DEVIATION 1.54 | 8.6 Weeks STANDARD_DEVIATION 1.56 |
| Sex: Female, Male Female | 113 Participants | 120 Participants | 113 Participants | 121 Participants | 467 Participants |
| Sex: Female, Male Male | 127 Participants | 120 Participants | 117 Participants | 120 Participants | 484 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 240 | 0 / 240 | 0 / 230 | 0 / 241 |
| other Total, other adverse events | 234 / 240 | 229 / 240 | 221 / 230 | 235 / 241 |
| serious Total, serious adverse events | 29 / 240 | 26 / 240 | 38 / 230 | 24 / 241 |
Outcome results
Primary
Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F-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. Primary outcome results correspond to antibody concentrations for all serotypes presented at the exception of those for the antibodies against the cross-reactive pneumococcal serotype 3 (ANTI-3).
Time frame: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-1 | 1.54 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-3 | 0.06 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-4 | 1.78 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-5 | 2.48 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-6A | 0.14 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-6B | 0.51 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-7F | 2.30 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-9V | 1.57 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-14 | 4.19 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-18C | 2.84 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-19A | 1.63 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-19F | 3.65 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-23F | 0.62 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-5 | 2.37 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-23F | 0.69 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-19A | 1.18 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-9V | 1.77 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-4 | 1.99 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-1 | 1.59 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-18C | 2.56 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-14 | 4.45 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-6B | 0.58 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-6A | 1.12 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-3 | 0.06 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-19F | 3.31 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-7F | 2.44 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-19A | 0.18 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-5 | 2.19 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-6A | 0.12 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-23F | 0.72 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-6B | 0.48 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-7F | 2.20 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-19F | 3.68 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-9V | 1.42 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-14 | 4.21 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-18C | 2.56 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-1 | 1.37 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-3 | 0.05 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-4 | 1.68 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-18C | 3.17 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-9V | 2.27 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-5 | 2.81 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-1 | 2.18 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-7F | 3.16 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-6B | 0.49 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-4 | 2.83 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-3 | 2.27 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-6A | 2.05 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-14 | 4.20 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-23F | 1.59 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-19F | 3.07 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Primary Phase of the Study | ANTI-19A | 2.67 µg/mL |
Comparison: ANTI-1 serotype test :to demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [0.75, 1.07]
Comparison: ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [0.77, 1.14]
Comparison: ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [0.75, 1.03]
Comparison: ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [0.71, 1.23]
Comparison: ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [0.81, 1.1]
Comparison: ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [0.76, 1.06]
Comparison: ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [0.81, 1.15]
Comparison: ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [0.74, 1.14]
Comparison: ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [0.81, 1.23]
Comparison: ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [0.89, 1.48]
Comparison: ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 9 out of 11 vaccine serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.9% CI of the ELISA GMC ratios (Prevnar13/11Pn) and (Synflorix/11Pn) groups \< a limit of 2-fold for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [1.44, 2.03]
Comparison: ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [0.72, 1.02]
Comparison: ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [0.7, 1.05]
Comparison: ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [0.78, 1.07]
Comparison: ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [0.64, 1.11]
Comparison: ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [0.76, 1.06]
Comparison: ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [0.67, 0.93]
Comparison: ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [0.77, 1.09]
Comparison: ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [0.81, 1.26]
Comparison: ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [0.9, 1.38]
Comparison: ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [0.81, 1.37]
Comparison: ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [1.51, 2.39]
Comparison: ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™ 1 month post-dose 3 was non-inferior for at least 10 out of 12 vaccine serotypes to Prevnar13 (for 6A\&19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of Enzyme-linked immunosorbent assay (ELISA) GMCs. Criteria: UL of the 2-sided 95.8 CI of the ELISA GMC ratios (Prevnar13/12Pn) and (Synflorix/12Pn) groups \< a limit of 2-fold for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [1.94, 2.77]
Primary
Percentage (%) of Subjects (Prevnar13 and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-19A Pneumococcal Serotype
N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 19A (ANTI-19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).
Time frame: 1 month post-dose 3 (primary phase)
Population: The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 11Pn Group | Percentage (%) of Subjects (Prevnar13 and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-19A Pneumococcal Serotype | 98.6 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Prevnar13 and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-19A Pneumococcal Serotype | 99.5 Percentage of participants |
Comparison: ANTI-19A serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [-1.46, 3.66]
Primary
Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes
N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotype 6A and 19A (ANTI-6A and 19A). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).
Time frame: 1 month post-dose 3 (primary phase)
Population: The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 11Pn Group | Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes | ANTI-6A | 88.3 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes | ANTI-19A | 95.8 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes | ANTI-6A | 99.5 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Prevnar13 and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Anti-6A and 19A Pneumococcal Serotypes | ANTI-19A | 99.5 Percentage of participants |
Comparison: ANTI-6A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \<10% for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [7.22, 16.49]
Comparison: ANTI-19A serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A \& 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \<10% for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [1.03, 7.57]
Primary
Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes
N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).
Time frame: 1 month post-dose 3 (primary phase)
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-1 | 99.5 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-4 | 97.7 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-5 | 100 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-6B | 77.5 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-7F | 99.6 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-9V | 98.6 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-14 | 99.5 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-18C | 99.1 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-19F | 100 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-23F | 81.1 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-18C | 98.1 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-1 | 98.6 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-9V | 99.0 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-4 | 96.7 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-23F | 83.8 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-5 | 99.5 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-14 | 100 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-6B | 75.2 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-19F | 97.6 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 11Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-7F | 99.5 Percentage of participants |
Comparison: ANTI-1 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [-3.89, 1.36]
Comparison: ANTI-4 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [-4.94, 2.45]
Comparison: ANTI-5 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [-2.82, 1.38]
Comparison: ANTI-6B serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [-10.65, 6.13]
Comparison: ANTI-7F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [-2.39, 2.21]
Comparison: ANTI-9V serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [-2.36, 3.22]
Comparison: ANTI-14 serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [-1.51, 2.66]
Comparison: ANTI-18C serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [-4.18, 1.7]
Comparison: ANTI-19F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [-5.64, -0.52]
Comparison: ANTI-23F serotype test: To demonstrate that 11Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 9 out of 11 serotypes to Prevnar13 (for 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.9 % CI of the difference between (Prevnar13 minus 11Pn) and (Synflorix minus 11Pn) groups \< 10 % for at least 9 out of 11 vaccine pneumococcal serotypes.95.9% CI: [-4.84, 10.25]
Primary
Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes
N = number of subjects with post primary vaccination results available. % = percentage of subjects with ELISA pneumococcal antibody concentrations ≥ 0.2 μg/mL. Antibodies assessed for this outcome measure were those against the vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (ANTI-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F). Antibody concentrations were measured by 22F-Inhibition enzyme-linked immunosorbent assay (ELISA).
Time frame: 1 month post-dose 3 (primary phase)
Population: The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-1 | 99.1 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-4 | 96.7 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-5 | 99.5 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-6B | 79.9 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-7F | 99.1 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-9V | 99.1 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-14 | 100 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-18C | 98.6 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-19F | 98.6 Percentage of participants |
| 11Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-23F | 81.3 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-18C | 98.1 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-1 | 98.6 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-9V | 99.0 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-4 | 96.7 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-23F | 83.8 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-5 | 99.5 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-14 | 100 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-6B | 75.2 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-19F | 97.6 Percentage of participants |
| 12Pn Group | Percentage (%) of Subjects (Synflorix and 12Pn Groups) With Antibody Concentration ≥ 0.2 μg/mL for Pneumococcal Serotypes | ANTI-7F | 99.5 Percentage of participants |
Comparison: ANTI-1 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [-3.44, 2.22]
Comparison: ANTI-4 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [-4.03, 3.86]
Comparison: ANTI-5 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [-2.37, 2.3]
Comparison: ANTI-6B serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [-12.94, 3.6]
Comparison: ANTI-7F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [-1.93, 3.06]
Comparison: ANTI-9V serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [-2.72, 2.64]
Comparison: ANTI-14 serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [-1.94, 1.9]
Comparison: ANTI-18C serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [-3.72, 2.52]
Comparison: ANTI-19F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [-4.38, 2.1]
Comparison: ANTI-23F serotype test: To demonstrate that 12Pn co-administered with Infanrix hexa™1 month post-dose 3 was non-inferior for at least 10 out of 12 serotypes to Prevnar13 (for 6A and 19A) or Synflorix™ (for 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) in terms of % of subjects with antibody concentrations ≥ 0.2 μg/mL. Criteria: UL of 2-sided 95.8 % CI of the difference between (Prevnar13 minus 12Pn) and (Synflorix minus 12Pn) groups \< 10 % for at least 10 out of 12 vaccine pneumococcal serotypes.95.8% CI: [-5.07, 10.06]
Secondary
Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study
Antibodies assessed for this outcome measure was that against the cross-reactive pneumococcal serotype 6A (ANTI-6A). 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 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study | ANTI-6A (M11) | 1.07 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study | ANTI-6A (M10) | 0.23 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study | ANTI-6A (M10) | 0.89 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study | ANTI-6A (M11) | 7.94 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study | ANTI-6A (M11) | 0.91 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study | ANTI-6A (M10) | 0.22 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study | ANTI-6A (M11) | 9.31 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotype 6A During the Booster Phase of the Study | ANTI-6A (M10) | 0.64 µg/mL |
Secondary
Antibody Concentrations Against Pneumococcal Serotype 6C During the Booster Phase of the Study.
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.
Time frame: At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine
Population: The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase but no analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.
Secondary
Antibody Concentrations Against Pneumococcal Serotype 6C During the Primary Phase of the Study.
No analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available.
Time frame: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine
Population: The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase. But no analysis was performed on Enzyme-Linked ImmunoSorbent Assay (ELISA) testing for antibody concentrations against vaccine serotype 6C as no specific qualified/validated assay was available
Secondary
Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -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. Analysis of concentrations of antibodies against the cross-reactive pneumococcal serotype 6C (ANTI-6C) will not be performed due to unavailability of a specific qualified assay.
Time frame: At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-9V (M10) | 0.76 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-5 (M10) | 0.51 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-18C (M11) | 7.65 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-3 (M11) | 0.07 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-18C (M10) | 0.76 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-5 (M11) | 3.23 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-4 (M11) | 3.89 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-7F (M11) | 4.88 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-3 (M10) | 0.06 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-6B (M10) | 0.57 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19F (M11) | 8.67 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-7F (M10) | 1.04 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19A (M11) | 5.35 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-6B (M11) | 2.66 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-1 (M10) | 0.26 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19A (M10) | 0.46 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-23F (M10) | 0.51 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-4 (M10) | 0.49 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-14 (M11) | 6.17 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-14 (M10) | 1.30 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-23F (M11) | 3.09 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-1 (M11) | 2.49 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-9V (M11) | 4.14 µg/mL |
| 11Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19F (M10) | 1.11 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-4 (M10) | 0.48 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19A (M10) | 0.36 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19A (M11) | 4.46 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19F (M10) | 1.11 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19F (M11) | 8.50 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-4 (M11) | 4.18 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-23F (M10) | 0.54 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-23F (M11) | 3.31 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-1 (M11) | 2.18 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-5 (M10) | 0.51 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-1 (M10) | 0.26 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-5 (M11) | 3.31 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-6B (M10) | 0.64 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-3 (M10) | 0.06 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-6B (M11) | 4.09 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-7F (M10) | 0.99 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-7F (M11) | 4.57 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-9V (M10) | 0.77 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-3 (M11) | 0.07 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-9V (M11) | 4.36 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-14 (M10) | 1.45 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-14 (M11) | 6.52 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-18C (M10) | 0.68 µg/mL |
| 12Pn Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-18C (M11) | 7.20 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-5 (M10) | 0.48 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-1 (M11) | 2.25 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-18C (M11) | 8.00 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-9V (M10) | 0.70 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-18C (M10) | 0.74 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-23F (M11) | 2.98 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19A (M11) | 1.11 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-9V (M11) | 3.68 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-4 (M11) | 4.06 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-4 (M10) | 0.50 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-14 (M10) | 1.12 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-3 (M11) | 0.07 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-23F (M10) | 0.49 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19A (M10) | 0.18 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-14 (M11) | 5.75 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-6B (M11) | 2.53 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-3 (M10) | 0.06 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-6B (M10) | 0.59 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19F (M11) | 8.22 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-7F (M10) | 0.94 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-1 (M10) | 0.26 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-5 (M11) | 3.05 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19F (M10) | 1.10 µg/mL |
| Synflorix Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-7F (M11) | 4.31 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-23F (M11) | 6.49 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-9V (M11) | 5.83 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-1 (M10) | 0.44 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-1 (M11) | 3.84 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-3 (M10) | 0.25 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-3 (M11) | 1.68 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-4 (M10) | 0.41 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-4 (M11) | 3.86 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-5 (M10) | 0.77 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-5 (M11) | 6.84 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-6B (M10) | 0.22 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-6B (M11) | 3.80 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-7F (M10) | 1.21 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-7F (M11) | 6.34 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-9V (M10) | 0.53 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-14 (M10) | 1.66 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-14 (M11) | 10.05 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-18C (M10) | 0.59 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-18C (M11) | 6.01 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19A (M10) | 0.42 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19A (M11) | 7.06 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19F (M10) | 0.50 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-19F (M11) | 6.40 µg/mL |
| Prevnar13 Group | Antibody Concentrations Against Pneumococcal Serotypes During the Booster Phase of the Study | ANTI-23F (M10) | 0.34 µg/mL |
Secondary
Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study
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 (≥) 100 EL.U/mL.
Time frame: At study Month 10 (M10) and Month 11 (M11), e.g.: prior to and at one month post booster vaccination with pneumococcal vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 11Pn Group | Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study | Anti-PD (M10) | 445.9 EL.U/mL |
| 11Pn Group | Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study | Anti-PD (M11) | 1866.0 EL.U/mL |
| 12Pn Group | Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study | Anti-PD (M11) | 1835.5 EL.U/mL |
| 12Pn Group | Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study | Anti-PD (M10) | 447.6 EL.U/mL |
| Synflorix Group | Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study | Anti-PD (M10) | 460.0 EL.U/mL |
| Synflorix Group | Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study | Anti-PD (M11) | 2128.4 EL.U/mL |
| Prevnar13 Group | Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study | Anti-PD (M10) | 70.9 EL.U/mL |
| Prevnar13 Group | Concentrations of Antibodies Against Protein D (Anti-PD) During the Booster Phase of the Study | Anti-PD (M11) | 77.8 EL.U/mL |
Secondary
Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study
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 (≥) 100 EL.U/mL.
Time frame: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 11Pn Group | Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study | 1430.1 EL.U/mL |
| 12Pn Group | Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study | 1194.2 EL.U/mL |
| Synflorix Group | Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study | 1344.8 EL.U/mL |
| Prevnar13 Group | Concentrations of Antibodies Against Protein D (Anti-PD) During the Primary Phase of the Study | 64.4 EL.U/mL |
Secondary
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study
Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \[≥\] 38.0 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (\>) 40.0°C.
Time frame: Within the 4-day (Days 0-3) period after booster vaccination
Population: The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Fever | 2 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Loss Appet. | 80 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Fever | 72 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Loss Appet. | 6 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Drowsiness | 93 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Loss Appet. | 66 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Irr./Fuss. | 140 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Drowsiness | 9 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Irr./Fuss. | 14 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Fever. | 80 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Irr./Fuss. | 107 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Drowsiness | 109 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Drowsiness | 6 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Irr./Fuss. | 136 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Loss Appet. | 85 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Irr./Fuss. | 117 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Loss Appet. | 64 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Fever. | 72 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Loss Appet. | 3 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Drowsiness | 100 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Irr./Fuss. | 14 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Drowsiness | 79 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Fever | 66 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Fever | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Loss Appet. | 65 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Drowsiness | 84 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Drowsiness | 4 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Drowsiness | 68 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Irr./Fuss. | 137 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Irr./Fuss. | 12 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Irr./Fuss. | 109 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Loss Appet. | 83 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Loss Appet. | 9 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Fever. | 68 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Fever | 1 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Fever | 60 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Loss Appet. | 45 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Irr./Fuss. | 9 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Irr./Fuss. | 129 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Drowsiness | 96 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Fever. | 75 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Drowsiness | 81 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Fever | 67 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Fever | 0 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Drowsiness | 2 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Grade 3 Loss Appet. | 7 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Any Loss Appet. | 61 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Booster Phase of the Study | Related Irr./Fuss. | 107 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study
Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness (Irr./Fuss.), Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \[≥\] 38.0 degrees Celsius \[°C\]),. Any = Occurrence of the specified solicited general symptom, regardless of intensity or relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irr./Fuss. = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Rectal temperature higher than (\>) 40.0°C.
Time frame: Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).
Population: The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Loss Appet., post D2 | 69 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Fever, post D1 | 108 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Fever, post D3 | 50 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Irr./Fuss., post D2 | 123 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Irr./Fuss., post D2 | 18 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Fever, post D1 | 0 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Loss Appet., post D3 | 0 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Irr./Fuss., post D2 | 151 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Drowsiness, post D2 | 96 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Fever, post D1 | 94 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Loss Appet., post D3 | 63 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Drowsiness, post D2 | 6 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Drowsiness, post D2 | 125 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Irr./Fuss., post D1 | 151 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Fever, post D3 | 0 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Irr./Fuss., post D3 | 95 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Irr./Fuss., post D3 | 6 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Irr./Fuss., post D1 | 16 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Drowsiness, post D1 | 7 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Irr./Fuss., post D3 | 117 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Drowsiness, post D3 | 80 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Irr./Fuss., post D1 | 119 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Drowsiness, post D1 | 148 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Drowsiness, post D3 | 4 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Drowsiness, post D3 | 99 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Loss Appet., post D1 | 85 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Fever, post D3 | 51 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Fever, post D2 | 87 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Fever, post D2 | 0 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Loss Appet., post D1 | 2 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Loss Appet., post D3 | 49 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Fever, post D2 | 97 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Loss Appet., post D2 | 52 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Loss Appet., post D1 | 59 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Drowsiness, post D1 | 124 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Loss Appet., post D2 | 2 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Drowsiness, post D3 | 67 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Drowsiness, post D1 | 144 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Drowsiness, post D1 | 6 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Drowsiness, post D1 | 104 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Irr./Fuss., post D1 | 156 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Irr./Fuss., post D1 | 15 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Irr./Fuss., post D1 | 122 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Loss Appet., post D1 | 89 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Loss Appet., post D1 | 2 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Loss Appet., post D1 | 65 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Fever, post D1 | 104 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Fever, post D1 | 0 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Fever, post D1 | 91 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Drowsiness, post D2 | 115 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Drowsiness, post D2 | 7 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Drowsiness, post D2 | 89 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Irr./Fuss., post D2 | 151 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Irr./Fuss., post D2 | 12 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Irr./Fuss., post D2 | 113 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Loss Appet., post D2 | 78 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Loss Appet., post D2 | 3 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Loss Appet., post D2 | 58 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Fever, post D2 | 84 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Fever, post D2 | 0 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Fever, post D2 | 75 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Drowsiness, post D3 | 92 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Drowsiness, post D3 | 2 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Irr./Fuss., post D3 | 123 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Irr./Fuss., post D3 | 7 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Irr./Fuss., post D3 | 92 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Loss Appet., post D3 | 62 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Loss Appet., post D3 | 3 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Loss Appet., post D3 | 42 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Fever, post D3 | 53 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Fever, post D3 | 0 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Fever, post D3 | 51 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Irr./Fuss., post D2 | 114 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Loss Appet., post D2 | 71 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Loss Appet., post D1 | 56 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Loss Appet., post D2 | 1 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Drowsiness, post D1 | 129 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Loss Appet., post D2 | 48 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Loss Appet., post D1 | 3 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Loss Appet., post D3 | 54 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Fever, post D2 | 90 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Fever, post D2 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Loss Appet., post D1 | 81 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Drowsiness, post D1 | 10 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Fever, post D2 | 82 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Drowsiness, post D3 | 88 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Irr./Fuss., post D1 | 98 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Fever, post D3 | 61 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Drowsiness, post D3 | 3 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Drowsiness, post D3 | 70 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Irr./Fuss., post D1 | 17 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Irr./Fuss., post D3 | 118 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Irr./Fuss., post D3 | 8 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Irr./Fuss., post D1 | 134 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Fever, post D3 | 56 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Irr./Fuss., post D3 | 96 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Fever, post D3 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Drowsiness, post D2 | 105 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Fever, post D1 | 92 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Loss Appet., post D3 | 67 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Drowsiness, post D2 | 6 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Drowsiness, post D2 | 81 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Fever, post D1 | 0 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Drowsiness, post D1 | 95 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Irr./Fuss., post D2 | 141 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Irr./Fuss., post D2 | 17 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Fever, post D1 | 107 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Loss Appet., post D3 | 3 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Irr./Fuss., post D2 | 10 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Loss Appet., post D1 | 57 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Loss Appet., post D3 | 5 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Fever, post D3 | 58 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Loss Appet., post D2 | 72 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Irr./Fuss., post D2 | 128 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Drowsiness, post D1 | 10 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Irr./Fuss., post D3 | 112 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Loss Appet., post D2 | 3 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Loss Appet., post D1 | 2 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Irr./Fuss., post D1 | 138 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Drowsiness, post D1 | 129 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Loss Appet., post D2 | 56 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Drowsiness, post D2 | 8 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Irr./Fuss., post D3 | 7 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Fever, post D1 | 0 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Fever, post D2 | 90 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Loss Appet., post D1 | 73 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Loss Appet., post D3 | 41 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Loss Appet., post D3 | 54 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Fever, post D2 | 0 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Fever, post D1 | 87 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Irr./Fuss., post D3 | 87 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Drowsiness, post D1 | 103 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Fever, post D2 | 82 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Irr./Fuss., post D1 | 103 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Fever, post D3 | 49 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Fever, post D1 | 76 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Drowsiness, post D3 | 87 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Drowsiness, post D2 | 97 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Fever, post D3 | 0 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Any Drowsiness, post D2 | 111 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Drowsiness, post D3 | 5 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Grade 3 Irr./Fuss., post D1 | 10 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Irr./Fuss., post D2 | 106 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms With Relationship to Vaccination, During the Primary Phase of the Study | Related Drowsiness, post D3 | 71 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm).
Time frame: Within the 4-day (Days 0-3) period after booster vaccination
Population: The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Grade 3 Pain | 13 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Any Swelling | 84 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Any Redness | 109 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Any Pain | 112 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Grade 3 Redness | 5 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Grade 3 Swelling | 8 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Any Swelling | 88 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Grade 3 Swelling | 7 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Any Redness | 117 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Grade 3 Pain | 16 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Any Pain | 123 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Grade 3 Redness | 10 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Any Pain | 119 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Grade 3 Swelling | 5 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Any Swelling | 89 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Grade 3 Redness | 7 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Grade 3 Pain | 18 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Any Redness | 108 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Grade 3 Swelling | 7 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Any Pain | 110 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Grade 3 Pain | 8 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Any Redness | 107 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Grade 3 Redness | 5 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Phase of the Study | Any Swelling | 85 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase
Assessed local symptoms were pain, redness and swelling. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm).
Time frame: Within the 4-day (Days 0-3) post-vaccination period following each primary dose (D).
Population: The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases, with analysis done solely on subjects for whom post-vaccination results about solicited symptoms were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Pain, post D3 | 76 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Pain, post D1 | 104 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Pain, post D2 | 12 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Swelling, post D1 | 1 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Pain, post D3 | 4 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Swelling, post D2 | 61 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Redness, post D2 | 2 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Pain, post D2 | 89 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Redness, post D3 | 93 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Swelling, post D2 | 2 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Swelling, post D3 | 2 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Swelling, post D1 | 51 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Redness, post D3 | 3 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Redness, post D1 | 82 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Redness, post D2 | 86 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Redness, post D1 | 0 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Swelling, post D3 | 72 Participants |
| 11Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Pain, post D1 | 16 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Swelling, post D3 | 76 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Redness, post D1 | 90 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Swelling, post D3 | 5 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Redness, post D1 | 0 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Pain, post D1 | 105 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Swelling, post D2 | 72 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Pain, post D1 | 5 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Redness, post D2 | 95 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Swelling, post D2 | 3 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Pain, post D2 | 12 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Swelling, post D1 | 4 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Pain, post D3 | 75 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Pain, post D3 | 4 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Swelling, post D1 | 57 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Redness, post D3 | 85 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Redness, post D2 | 1 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Redness, post D3 | 2 Participants |
| 12Pn Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Pain, post D2 | 100 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Pain, post D2 | 10 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Redness, post D2 | 78 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Redness, post D2 | 1 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Swelling, post D2 | 54 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Swelling, post D2 | 5 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Pain, post D3 | 76 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Pain, post D3 | 6 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Redness, post D3 | 91 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Redness, post D3 | 2 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Swelling, post D3 | 58 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Swelling, post D3 | 2 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Pain, post D1 | 94 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Pain, post D1 | 12 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Redness, post D1 | 72 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Redness, post D1 | 1 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Swelling, post D1 | 46 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Swelling, post D1 | 7 Participants |
| Synflorix Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Pain, post D2 | 88 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Redness, post D3 | 1 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Pain, post D2 | 90 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Redness, post D1 | 0 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Redness, post D3 | 85 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Pain, post D3 | 3 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Redness, post D2 | 79 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Swelling, post D1 | 47 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Pain, post D3 | 75 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Swelling, post D2 | 2 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Pain, post D2 | 6 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Swelling, post D1 | 1 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Swelling, post D2 | 49 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Redness, post D2 | 1 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Pain, post D1 | 6 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Pain, post D1 | 85 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Swelling, post D3 | 61 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Grade 3 Swelling, post D3 | 3 Participants |
| Prevnar13 Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Phase | Any Redness, post D1 | 75 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study
A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
Time frame: From Day 0 to Month 11
Population: The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 11Pn Group | Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study | 29 Participants |
| 12Pn Group | Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study | 26 Participants |
| Synflorix Group | Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study | 38 Participants |
| Prevnar13 Group | Number of Subjects With Any Serious Adverse Events (SAEs) During the Entire Duration of the Study | 24 Participants |
Secondary
Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study
A SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalisation, as per the medical or scientific judgement of the physician. Any = Occurrence of a SAE, regardless of relationship to vaccination.
Time frame: From Month 0 to Month 3
Population: The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 11Pn Group | Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study | 12 Participants |
| 12Pn Group | Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study | 11 Participants |
| Synflorix Group | Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study | 17 Participants |
| Prevnar13 Group | Number of Subjects With Any Serious Adverse Events (SAEs)During the Primary Phase of the Study | 12 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study
An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
Time frame: Within the 31-day (Days 0-30) period post booster vaccination
Population: The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose against pneumococcal diseases.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 11Pn Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study | 69 Participants |
| 12Pn Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study | 68 Participants |
| Synflorix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study | 74 Participants |
| Prevnar13 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Booster Phase of the Study | 53 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study
An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
Time frame: Within the 31-day (Days 0-30) period post primary vaccination, across doses
Population: The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses priming against pneumococcal diseases.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 11Pn Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study | 110 Participants |
| 12Pn Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study | 108 Participants |
| Synflorix Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study | 123 Participants |
| Prevnar13 Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) During the Primary Phase of the Study | 124 Participants |
Secondary
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study
Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143).
Time frame: At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study | 4866.4 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study | 3896.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study | 2191.0 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Booster Phase of the Study | 5720.1 Titers |
Secondary
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study
Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 19A (OPA-19A). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) serotype-specific Lower Limit of Quantification (143).
Time frame: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine
Population: The analysis was performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study | 1813.0 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study | 1523.9 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study | 759.6 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 19A During the Primary Phase of the Study | 2056.6 Titers |
Secondary
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Booster Phase of the Study
No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.
Time frame: At study Month 11, e. g. at one month post-Booster vaccination with pneumococcal vaccine
Population: The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Booster Phase but no analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.
Secondary
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes 6C During the Primary Phase of the Study
No analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.
Time frame: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine
Population: The analysis was to be performed on the According-to-Protocol cohort for immunogenicity of the Primary Phase but no analysis was performed on opsonophagocytic activity for antibody titers against vaccine serotype 6C as no specific qualified/validated assay was available.
Secondary
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study
Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.
Time frame: At study Month 11, e.g.: at one month post booster vaccination with pneumococcal vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity of the Booster Phase which included all evaluable subjects for whom data concerning booster immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component before or after booster vaccination against pneumococcal diseases.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-7F | 8362.9 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-5 | 134.5 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-23F | 2562.9 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-14 | 2038.4 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-19F | 523.9 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-6A | 116.8 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-4 | 1455.3 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-3 | 9.7 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-9V | 3406.9 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-6B | 681.4 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-1 | 192.4 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-18C | 914.8 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-3 | 10.5 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-7F | 7516.4 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-1 | 192.4 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-14 | 2519.9 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-9V | 3616.1 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-4 | 1650.5 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-19F | 565.3 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-5 | 133.3 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-23F | 2923.6 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-6A | 3436.7 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-18C | 781.2 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-6B | 1246.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-14 | 2285.1 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-1 | 216.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-3 | 10.9 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-4 | 1550.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-5 | 133.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-6A | 146.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-6B | 694.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-7F | 7880.8 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-9V | 3260.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-18C | 912.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-19F | 759.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-23F | 2600.0 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-14 | 2772.6 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-6B | 1727.9 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-6A | 5200.7 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-1 | 207.6 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-18C | 610.7 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-5 | 269.9 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-4 | 1972.2 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-23F | 24350.4 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-3 | 317.2 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-9V | 8470.4 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-7F | 16592.6 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Booster Phase of the Study | OPA-19F | 438.0 Titers |
Secondary
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study
Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19F and -23F). The cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8. Testing for opsonophagocytic activity against the cross-reactive pneumococcal serotype 6C will not be performed due to unavailability of a specific qualified assay.
Time frame: At study Month 3, e. g. at one month post-Dose 3 of pneumococcal vaccine
Population: The analysis was performed on the ATP cohort for immunogenicity of the Primary Phase which included all evaluable subjects for whom data concerning primary immunogenicity outcome measures were available for antibodies against at least one vaccine antigen component after primary vaccination against pneumococcal diseases.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-18C | 100.9 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-23F | 989.6 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-9V | 1212.9 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-1 | 13.2 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-14 | 1000.8 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-4 | 527.3 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-5 | 43.0 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-3 | 4.8 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-19F | 144.2 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-6A | 37.4 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-6B | 478.3 Titers |
| 11Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-7F | 3515.0 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-3 | 5.2 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-7F | 4472.3 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-5 | 46.7 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-14 | 1699.1 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-18C | 131.5 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-9V | 1629.0 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-1 | 15.6 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-6B | 603.2 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-6A | 1292.6 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-4 | 609.0 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-23F | 1377.9 Titers |
| 12Pn Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-19F | 201.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-9V | 1469.9 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-1 | 13.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-3 | 5.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-4 | 616.7 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-5 | 40.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-6A | 36.5 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-6B | 622.6 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-7F | 3424.1 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-14 | 1417.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-18C | 72.0 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-19F | 210.4 Titers |
| Synflorix Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-23F | 1097.3 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-6B | 742.3 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-6A | 2832.0 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-1 | 26.4 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-18C | 145.7 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-5 | 57.2 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-4 | 540.1 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-23F | 5136.4 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-19F | 66.0 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-9V | 1614.5 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-7F | 9737.9 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-3 | 97.2 Titers |
| Prevnar13 Group | Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes During the Primary Phase of the Study | OPA-14 | 2034.4 Titers |