Infections, Streptococcal
Conditions
Keywords
Booster vaccination, Pneumococcal vaccine, Catch-up vaccination, Pneumococcal disease, Safety, Immunogenicity
Brief summary
The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects previously enrolled in the primary vaccination study NCT00678301. This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00678301).
Interventions
BIOLOGICALPneumococcal vaccine GSK1024850A
Intramuscular injection, 1 or 2 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Months to 21 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol. * A male or female, between and including 15-21 months of age at the time of visit 1. * For the Pn-Pn group, subjects who completed the full vaccination course in study NCT00678301. For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT00678301. * Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination. * Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF. * 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 (pharmaceutical product or device). * Administration of any pneumococcal vaccine since the end of study NCT00678301. * Any confirmed or suspected immunosuppressive or immunodeficient condition, since the end of study NCT00678301, based on medical history and physical examination. * Major congenital defects or serious chronic illness. * History of any progressive neurological disorders or seizures. * Acute disease and/or fever at the time of enrolment. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. * Administration of immunoglobulins and/or any blood products less than 3 months prior to visit 1 or planned use during the study. * Child in care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited) | Within 31 days (Day 0-Day 30) after booster vaccination | The incidence and nature of Grade 3 symptoms (solicited and unsolicited), reported during the 31-day (Days 0-30) post-vaccination are presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Within 4 days (Day 0-Day 3) after the booster dose | Assessed solicited general symptoms were drowsiness, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness and Irritability = symptom that prevented normal activity. Grade 3 Loss of appetite = not eating at all. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 31 days (Day 0-Day 30) after each vaccine dose | An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From the first vaccination up to one month (31 days) after the last vaccination for each subject | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group | Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (μg/mL). Pneumococcal serotype specific total immunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was ≥ 0.05 μg/mL. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Within 4 days (Day 0-Day 3) after the booster dose | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site. |
| Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group | Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (μg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was ≥ 0.05 μg/mL. |
| Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group | OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and Opsono-19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. |
| Concentrations of Antibodies Against Protein D (PD) | Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group | Concentrations of antibodies against protein D (PD) were determined by ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is ≥ 100 ELISA units per milliliter (EL.U/mL). |
| Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group | OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8. |
Countries
Mali
Participant flow
Pre-assignment details
A total of 218 subjects were enrolled (147 subjects in the Synflorix Primed Group and 71 subjects in the Synflorix Unprimed Group). A total of 210 subjects were vaccinated in the booster vaccination study (141 out of 160 from the Synflorix Primed Group and 69 out of 78 from the Synflorix Unprimed Group).
Participants by arm
| Arm | Count |
|---|---|
| Synflorix Primed Group Subjects who were previously primed with the Synflorix™ vaccine in study 10PN-PD-DIT-032, received a booster dose of the Synflorix™ vaccine, administered intramuscularly in the thigh or deltoid, at 15-21 months of age (Study Month 0). | 141 |
| Synflorix Unprimed Group Unprimed subjects from the control group of study 10PN-PD-DIT-032, received a two dose catch-up vaccination with the Synflorix™ vaccine, administered intramuscularly in the thigh or deltoid, during the second year of life (at 15-21 months of age \[Study Month 0\] and at 17-23 months of age \[Study Month 2\]). | 69 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Considered to be part of the other group | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | Synflorix Primed Group | Synflorix Unprimed Group | Total |
|---|---|---|---|
| Age, Continuous | 17 Months STANDARD_DEVIATION 1.11 | 16.9 Months STANDARD_DEVIATION 1.16 | 16.97 Months STANDARD_DEVIATION 1.12 |
| Sex: Female, Male Female | 75 Participants | 35 Participants | 110 Participants |
| Sex: Female, Male Male | 66 Participants | 34 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 125 / 141 | 64 / 69 |
| serious Total, serious adverse events | 0 / 141 | 0 / 69 |
Outcome results
Primary
Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited)
The incidence and nature of Grade 3 symptoms (solicited and unsolicited), reported during the 31-day (Days 0-30) post-vaccination are presented.
Time frame: Within 31 days (Day 0-Day 30) after booster vaccination
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Primed Group | Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited) | Local symptoms | 2 Participants |
| Synflorix Primed Group | Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited) | General symptoms | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited) | Any symptom | 3 Participants |
Secondary
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (μg/mL). The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was ≥ 0.05 μg/mL.
Time frame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Primed Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-6A, PRE | 0.13 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-6A, POST | 0.55 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-19A, PRE | 0.16 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-19A, POST | 1.13 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-19A, POST | 1.36 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-6A, PRE | 0.04 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-19A, PRE | 0.06 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Anti-6A, POST | 0.1 μg/mL |
Secondary
Concentrations of Antibodies Against Protein D (PD)
Concentrations of antibodies against protein D (PD) were determined by ELISA assay. Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per milliliter (EL.U/mL). Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is ≥ 100 ELISA units per milliliter (EL.U/mL).
Time frame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Primed Group | Concentrations of Antibodies Against Protein D (PD) | Anti-PD, PRE | 301.1 EL.U/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Protein D (PD) | Anti-PD, POST | 3710.1 EL.U/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Protein D (PD) | Anti-PD, PRE | 62.1 EL.U/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Protein D (PD) | Anti-PD, POST | 839.3 EL.U/mL |
Secondary
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per milliliter (μg/mL). Pneumococcal serotype specific total immunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was ≥ 0.05 μg/mL.
Time frame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-6B, POST | 4.44 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-9V, POST | 7.99 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-18C, PRE | 0.92 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-19F, POST | 12.96 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-1, PRE | 0.28 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-1, POST | 5.85 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-4, PRE | 0.32 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-4, POST | 10.44 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-5, PRE | 0.37 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-5, POST | 6.07 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-6B, PRE | 0.66 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-7F, PRE | 0.68 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-7F, POST | 7.82 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-9V, PRE | 0.73 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-14, PRE | 0.9 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-14, POST | 9.75 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-18C, POST | 23.99 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-19F, PRE | 0.82 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-23F, PRE | 0.35 μg/mL |
| Synflorix Primed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-23F, POST | 4.25 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-5, POST | 3.05 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-7F, POST | 4.5 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-9V, PRE | 0.03 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-14, PRE | 0.11 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-14, POST | 4.51 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-6B, PRE | 0.03 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-6B, POST | 0.78 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-19F, POST | 8.52 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-23F, POST | 1.05 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-23F, PRE | 0.03 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-1, PRE | 0.04 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-7F, PRE | 0.04 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-1, POST | 3.2 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-18C, PRE | 0.05 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-4, PRE | 0.06 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-19F, PRE | 0.09 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-4, POST | 6.54 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-9V, POST | 1.48 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-5, PRE | 0.04 μg/mL |
| Synflorix Unprimed Group | Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Anti-18C, POST | 10.95 μg/mL |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: Within 4 days (Day 0-Day 3) after the booster dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain | 40 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness | 17 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness | 2 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling | 67 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time frame: Within 4 days (Day 0-Day 3) after each vaccine dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 22 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 1 | 6 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 46 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 7 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Dose 2 | 2 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 55 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 31 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 25 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Redness, Across Doses | 8 Participants |
| Synflorix Primed Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Across Doses | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness and Irritability = symptom that prevented normal activity. Grade 3 Loss of appetite = not eating at all. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within 4 days (Day 0-Day 3) after each vaccine dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 15 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 3 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across Doses | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 21 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 19 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 3 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 3 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 17 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 3 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across Doses | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across Doses | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 34 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across Doses | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across Doses | 30 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 6 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across Doses | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across Doses | 6 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across Doses | 2 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across Doses | 1 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fatigue, fever \[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness and Irritability = symptom that prevented normal activity. Grade 3 Loss of appetite = not eating at all. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: Within 4 days (Day 0-Day 3) after the booster dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever | 34 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever | 31 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability | 8 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability | 8 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 1 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 0 Participants |
| Synflorix Primed Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 1 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: Within 31 days (Day 0-Day 30) after each vaccine dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Primed Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 95 Participants |
| Synflorix Unprimed Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 57 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From the first vaccination up to one month (31 days) after the last vaccination for each subject
Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine dose administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Synflorix Primed Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Synflorix Unprimed Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and Opsono-19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.
Time frame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Primed Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-6A, POST | 100.7 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-6A, PRE | 18.7 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-19A, PRE | 6.2 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-19A, POST | 91.5 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-19A, POST | 171.2 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-6A, POST | 106.3 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-19A, PRE | 5.9 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A | Opsono-6A, PRE | 24 Titers |
Secondary
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F
OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.
Time frame: Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group
Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects (i.e. those meeting all eligibility criteria, complying with the procedures and intervals defined in the protocol, with no elimination criteria during the study) for whom immunogenicity data were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F, PRE | 3230.6 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F, POST | 1084.2 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F, POST | 3476.4 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1, PRE | 9.3 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1, POST | 661.7 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4, PRE | 24 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4, POST | 6541.7 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5, PRE | 9 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5, POST | 340.5 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B, PRE | 82.6 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B, POST | 1729 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F, POST | 9116.9 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V, PRE | 407.9 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V, POST | 3640.4 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14, PRE | 84.3 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14, POST | 3281.8 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C, PRE | 6 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C, POST | 2413.2 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F, PRE | 12.8 Titers |
| Synflorix Primed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F, PRE | 90.7 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B, PRE | 38.7 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F, PRE | 2454.4 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C, PRE | 6.4 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14, PRE | 18.8 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F, PRE | 30.4 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-6B, POST | 1202.9 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-23F, POST | 3571 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-18C, POST | 2045.3 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1, PRE | 5.8 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-7F, POST | 9161.1 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-1, POST | 108.7 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-14, POST | 2246.1 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4, PRE | 11.8 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V, PRE | 138.2 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-4, POST | 2716.7 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F, POST | 693.7 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5, PRE | 4.3 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-9V, POST | 4596.5 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-5, POST | 71.9 Titers |
| Synflorix Unprimed Group | Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F | Opsono-19F, PRE | 4.8 Titers |