Trial Outcomes & Findings for Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A (NCT NCT00792909)
NCT ID: NCT00792909
Last Updated: 2017-12-14
Results Overview
Antibodies assessed 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) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
172 participants
Primary outcome timeframe
Pre-vaccination (PRE/ Day 0)
Results posted on
2017-12-14
Participant Flow
This study was an extension study of study 10PN-PD-DIT-002 (105539) for the primed subjects, and a self-contained study for the unprimed subjects.
During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
Synflorix™ Group 1
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
59
|
62
|
|
Overall Study
COMPLETED
|
51
|
58
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Synflorix™ Group 1
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A
Baseline characteristics by cohort
| Measure |
Synflorix™ Group 1
n=51 Participants
Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Synflorix™ Group 2
n=59 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
|
Unprimed Group
n=62 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
38.2 Months
STANDARD_DEVIATION 1.83 • n=5 Participants
|
38.0 Months
STANDARD_DEVIATION 1.81 • n=7 Participants
|
40.1 Months
STANDARD_DEVIATION 2.64 • n=5 Participants
|
38.82 Months
STANDARD_DEVIATION 2.35 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White - Caucasian / European heritage
|
50 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
168 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - central/ south Asian heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - east Asian heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian - south east Asian heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Pre-vaccination (PRE/ Day 0)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed 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) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=60 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-1 at PRE
|
0.06 μg/mL
Interval 0.05 to 0.08
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-4 at PRE
|
0.04 μg/mL
Interval 0.03 to 0.05
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-5 at PRE
|
0.07 μg/mL
Interval 0.05 to 0.09
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-6B at PRE
|
0.1 μg/mL
Interval 0.07 to 0.13
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-7F at PRE
|
0.08 μg/mL
Interval 0.05 to 0.12
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-9V at PRE
|
0.05 μg/mL
Interval 0.04 to 0.07
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-14 at PRE
|
0.25 μg/mL
Interval 0.16 to 0.38
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-18C at PRE
|
0.06 μg/mL
Interval 0.04 to 0.08
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-19F at PRE
|
0.23 μg/mL
Interval 0.14 to 0.38
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-23F at PRE
|
0.06 μg/mL
Interval 0.04 to 0.08
|
—
|
—
|
PRIMARY outcome
Timeframe: One week after dose 1 (Day 7)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed 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) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=60 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-1 at Day 7
|
0.6 μg/mL
Interval 0.47 to 0.76
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-4 at Day 7
|
2.37 μg/mL
Interval 1.91 to 2.94
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-5 at Day 7
|
0.45 μg/mL
Interval 0.34 to 0.59
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-6B at Day 7
|
0.2 μg/mL
Interval 0.14 to 0.29
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-7F at Day 7
|
0.92 μg/mL
Interval 0.67 to 1.25
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-9V at Day 7
|
0.33 μg/mL
Interval 0.23 to 0.48
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-14 at Day 7
|
0.54 μg/mL
Interval 0.34 to 0.86
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-18C at Day 7
|
1.45 μg/mL
Interval 1.01 to 2.06
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-19F at Day 7
|
1.82 μg/mL
Interval 1.27 to 2.6
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-23F at Day 7
|
0.1 μg/mL
Interval 0.07 to 0.15
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after dose 2 (Month 3)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed 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) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=60 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-1 at Month 3
|
2.81 μg/mL
Interval 2.25 to 3.51
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-4 at Month 3
|
8.44 μg/mL
Interval 7.16 to 9.94
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-5 at Month 3
|
3.54 μg/mL
Interval 2.96 to 4.23
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-6B at Month 3
|
1.11 μg/mL
Interval 0.84 to 1.46
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-7F at Month 3
|
6.1 μg/mL
Interval 4.99 to 7.46
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-9V at Month 3
|
2.22 μg/mL
Interval 1.74 to 2.82
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-14 at Month 3
|
6.48 μg/mL
Interval 4.98 to 8.44
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-18C at Month 3
|
22.28 μg/mL
Interval 18.14 to 27.36
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-19F at Month 3
|
17.03 μg/mL
Interval 13.38 to 21.68
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Anti-23F at Month 3
|
1.09 μg/mL
Interval 0.81 to 1.45
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 month after booster dose (Month 10) - in primary study (105539)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed 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) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=50 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=57 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-9V at Month 10
|
2.59 μg/mL
Interval 2.03 to 3.31
|
3.81 μg/mL
Interval 3.11 to 4.67
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-1 at Month 10
|
1.91 μg/mL
Interval 1.52 to 2.42
|
1.87 μg/mL
Interval 1.49 to 2.33
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-4 at Month 10
|
2.97 μg/mL
Interval 2.34 to 3.77
|
3.2 μg/mL
Interval 2.62 to 3.91
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-5 at Month 10
|
2.71 μg/mL
Interval 2.15 to 3.41
|
3.01 μg/mL
Interval 2.4 to 3.76
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-6B at Month 10
|
0.9 μg/mL
Interval 0.59 to 1.36
|
1.62 μg/mL
Interval 1.16 to 2.27
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-7F at Month 10
|
2.94 μg/mL
Interval 2.4 to 3.59
|
3.88 μg/mL
Interval 3.23 to 4.65
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-14 at Month 10
|
3.91 μg/mL
Interval 3.05 to 5.0
|
5.22 μg/mL
Interval 4.22 to 6.46
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-18C at Month 10
|
4.87 μg/mL
Interval 3.77 to 6.29
|
5.52 μg/mL
Interval 4.2 to 7.26
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-19F at Month 10
|
6.68 μg/mL
Interval 5.2 to 8.59
|
6.6 μg/mL
Interval 5.16 to 8.46
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-23F at Month 10
|
2.12 μg/mL
Interval 1.52 to 2.97
|
2.67 μg/mL
Interval 1.99 to 3.59
|
—
|
PRIMARY outcome
Timeframe: Pre-additional dose at Month 34 in the current study (Month 34)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed 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) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=50 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=57 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-1 at Month 34
|
0.13 μg/mL
Interval 0.1 to 0.17
|
0.17 μg/mL
Interval 0.14 to 0.22
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-4 at Month 34
|
0.15 μg/mL
Interval 0.1 to 0.23
|
0.19 μg/mL
Interval 0.14 to 0.25
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-5 at Month 34
|
0.24 μg/mL
Interval 0.19 to 0.31
|
0.33 μg/mL
Interval 0.26 to 0.42
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-6B at Month 34
|
0.5 μg/mL
Interval 0.29 to 0.88
|
1.01 μg/mL
Interval 0.62 to 1.64
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-7F at Month 34
|
0.33 μg/mL
Interval 0.24 to 0.46
|
0.51 μg/mL
Interval 0.42 to 0.61
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-9V at Month 34
|
0.24 μg/mL
Interval 0.18 to 0.33
|
0.49 μg/mL
Interval 0.34 to 0.69
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-14 at Month 34
|
0.62 μg/mL
Interval 0.39 to 0.97
|
1.1 μg/mL
Interval 0.69 to 1.75
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-18C at Month 34
|
0.37 μg/mL
Interval 0.26 to 0.54
|
0.49 μg/mL
Interval 0.35 to 0.7
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-19F at Month 34
|
1.42 μg/mL
Interval 0.8 to 2.51
|
1.44 μg/mL
Interval 0.82 to 2.53
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-23F at Month 34
|
0.41 μg/mL
Interval 0.23 to 0.71
|
0.67 μg/mL
Interval 0.41 to 1.11
|
—
|
PRIMARY outcome
Timeframe: One week after vaccination at Month 34+7 days (Mth34+D7)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed 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) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=50 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=57 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-1 at Mth34+D7
|
4.06 μg/mL
Interval 3.2 to 5.15
|
4.72 μg/mL
Interval 3.77 to 5.92
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-4 at Mth34+D7
|
7.54 μg/mL
Interval 5.98 to 9.5
|
9.97 μg/mL
Interval 7.68 to 12.95
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-5 at Mth34+D7
|
5.38 μg/mL
Interval 4.09 to 7.08
|
7.07 μg/mL
Interval 5.51 to 9.09
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-6B at Mth34+D7
|
4 μg/mL
Interval 2.82 to 5.69
|
6.33 μg/mL
Interval 4.75 to 8.45
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-7F at Mth34+D7
|
6.18 μg/mL
Interval 5.05 to 7.56
|
7.27 μg/mL
Interval 5.87 to 9.01
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-9V at Mth34+D7
|
7.48 μg/mL
Interval 5.88 to 9.51
|
10.17 μg/mL
Interval 7.86 to 13.16
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-14 at Mth34+D7
|
13.42 μg/mL
Interval 9.7 to 18.55
|
19.67 μg/mL
Interval 14.97 to 25.84
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-18C at Mth34+D7
|
17.12 μg/mL
Interval 12.77 to 22.94
|
22.62 μg/mL
Interval 17.58 to 29.11
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-19F at Mth34+D7
|
20.28 μg/mL
Interval 15.71 to 26.19
|
30.55 μg/mL
Interval 24.32 to 38.37
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix Group 1 and Synflorix Group 2
Anti-23F at Mth34+D7
|
6.23 μg/mL
Interval 4.34 to 8.94
|
8.42 μg/mL
Interval 6.38 to 11.11
|
—
|
SECONDARY outcome
Timeframe: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+ D7);Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed 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) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL..
Outcome measures
| Measure |
Unprimed Group
n=50 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=57 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-23F at Month 34
|
43 Participants
|
56 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-1 at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-1 at Month 34
|
43 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-1 at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-4 at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-4 at Month 34
|
41 Participants
|
54 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-4 at Mth34+D7
|
49 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-5 at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-5 at Month 34
|
49 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-5 at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-6B at Month 10
|
45 Participants
|
54 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-6B at Month 34
|
43 Participants
|
56 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-6B at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-7F at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-7F at Month 34
|
47 Participants
|
56 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-7F at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-9V at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-9V at Month 34
|
48 Participants
|
56 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-9V at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-14 at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-14 at Month 34
|
50 Participants
|
56 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-14 at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-18C at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-18C at Month 34
|
48 Participants
|
56 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-18C at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-19F at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-19F at Month 34
|
47 Participants
|
56 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-19F at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-23F at Month 10
|
49 Participants
|
56 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-23F at Mth34+D7
|
49 Participants
|
55 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed 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) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=60 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-1 at PRE
|
34 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-1 at Day 7
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-1 at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-4 at PRE
|
9 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-4 at Day 7
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-4 at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-5 at PRE
|
37 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-5 at Day 7
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-5 at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-6B at PRE
|
40 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-6B at Day 7
|
49 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-6B at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-7F at PRE
|
29 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-7F at Day 7
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-7F at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-9V at PRE
|
21 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-9V at Day 7
|
58 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-9V at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-14 at PRE
|
56 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-14 at Day 7
|
58 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-14 at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-18C at PRE
|
23 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-18C at Day 7
|
59 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-18C at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-19F at PRE
|
44 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-19F at Day 7
|
59 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-19F at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-23F at PRE
|
23 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-23F at Day 7
|
39 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group;
Anti-23F at Month 3
|
60 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
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 enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.2 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=50 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=57 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-1 at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-6B at Month 34
|
29 Participants
|
44 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-9V at Month 34
|
27 Participants
|
45 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-1 at Month 34
|
16 Participants
|
28 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-1 at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-4 at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-4 at Month 34
|
12 Participants
|
20 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-4 at Mth34+D7
|
49 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-5 at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-5 at Month 34
|
31 Participants
|
35 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-5 at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-6B at Month 10
|
44 Participants
|
54 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-6B at Mth34+D7
|
49 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-7F at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-7F at Month 34
|
37 Participants
|
53 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-7F at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-9V at Month 10
|
49 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-9V at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-14 at Month 10
|
50 Participants
|
57 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-14 at Month 34
|
37 Participants
|
49 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-14 at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-18C at Month 10
|
50 Participants
|
56 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-18C at Month 34
|
35 Participants
|
44 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-18C at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-19F at Month 10
|
49 Participants
|
56 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-19F at Month 34
|
39 Participants
|
47 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-19F at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-23F at Month 10
|
47 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-23F at Month 34
|
29 Participants
|
36 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-23F at Mth34+D7
|
49 Participants
|
55 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed 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) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=60 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-1 at PRE
|
10 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-1 at Day 7
|
54 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-1 at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-4 at PRE
|
4 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-4 at Day 7
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-4 at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-5 at PRE
|
9 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-5 at Day 7
|
47 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-5 at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-6B at PRE
|
19 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-6B at Day 7
|
29 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-6B at Month 3
|
56 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-7F at PRE
|
11 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-7F at Day 7
|
54 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-7F at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-9V at PRE
|
7 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-9V at Day 7
|
40 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-9V at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-14 at PRE
|
27 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-14 at Day 7
|
42 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-14 at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-18C at PRE
|
8 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-18C at Day 7
|
56 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-18C at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-19F at PRE
|
29 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-19F at Day 7
|
57 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-19F at Month 3
|
60 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-23F at PRE
|
11 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-23F at Day 7
|
16 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-23F at Month 3
|
56 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.
Outcome measures
| Measure |
Unprimed Group
n=48 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=55 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-6B at Month 10
|
292.2 Titers
Interval 147.1 to 580.3
|
458.8 Titers
Interval 254.8 to 825.9
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-6B at Month 34
|
61.5 Titers
Interval 22.8 to 165.6
|
126.3 Titers
Interval 59.4 to 268.5
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-6B at Mth34+D7
|
3312.9 Titers
Interval 1751.2 to 6267.2
|
3136 Titers
Interval 1730.0 to 5684.6
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-7F at Month 10
|
2257.8 Titers
Interval 1601.9 to 3182.3
|
3856.8 Titers
Interval 2890.4 to 5146.2
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-7F at Month 34
|
1329.1 Titers
Interval 778.8 to 2268.4
|
1225.5 Titers
Interval 842.5 to 1782.6
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-7F at Mth34+D7
|
20779 Titers
Interval 14616.7 to 29539.1
|
22461.4 Titers
Interval 16876.9 to 29893.7
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-9V at Month 10
|
1581.7 Titers
Interval 1147.7 to 2179.9
|
2013.9 Titers
Interval 1565.3 to 2591.0
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-9V at Month 34
|
307.4 Titers
Interval 210.3 to 449.4
|
292.3 Titers
Interval 221.0 to 386.6
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-1 at Month 10
|
243.9 Titers
Interval 137.3 to 433.3
|
176.9 Titers
Interval 104.0 to 301.0
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-1 at Month 34
|
5.5 Titers
Interval 4.3 to 7.0
|
6.2 Titers
Interval 4.9 to 8.0
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-1 at Mth34+D7
|
2342.2 Titers
Interval 1788.8 to 3066.7
|
2321.5 Titers
Interval 1827.1 to 2949.7
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-4 at Month 10
|
937.6 Titers
Interval 600.8 to 1463.4
|
1347 Titers
Interval 1068.8 to 1697.7
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-4 at Month 34
|
9.6 Titers
Interval 4.9 to 18.8
|
9.5 Titers
Interval 5.8 to 15.6
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-4 at Mth34+D7
|
13247.5 Titers
Interval 9898.0 to 17730.4
|
17732.6 Titers
Interval 13218.8 to 23787.7
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-5 at Month 10
|
154 Titers
Interval 94.2 to 251.6
|
181.2 Titers
Interval 125.4 to 262.0
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-5 at Month 34
|
6.7 Titers
Interval 5.2 to 8.6
|
8 Titers
Interval 6.1 to 10.6
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-5 at Mth34+D7
|
991.5 Titers
Interval 769.8 to 1277.1
|
1221.1 Titers
Interval 912.4 to 1634.2
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-9V at Mth34+D7
|
21193.6 Titers
Interval 16100.3 to 27898.2
|
19038.4 Titers
Interval 14154.7 to 25607.2
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-14 at Month 10
|
1092.5 Titers
Interval 691.9 to 1725.0
|
1207.1 Titers
Interval 961.4 to 1515.5
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-14 at Month 34
|
421.5 Titers
Interval 258.8 to 686.5
|
738.6 Titers
Interval 540.0 to 1010.2
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-14 at Mth34+D7
|
14310 Titers
Interval 10214.0 to 20048.7
|
14670.9 Titers
Interval 10258.0 to 20982.2
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-18C at Month 10
|
375.8 Titers
Interval 251.3 to 562.1
|
567.4 Titers
Interval 422.8 to 761.5
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-18C at Month 34
|
11 Titers
Interval 6.0 to 20.2
|
17.7 Titers
Interval 9.6 to 32.9
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-18C at Mth34+D7
|
6095.8 Titers
Interval 4090.7 to 9083.8
|
6448.7 Titers
Interval 4258.7 to 9764.9
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-19F at Month 10
|
463.7 Titers
Interval 318.3 to 675.6
|
950.5 Titers
Interval 653.3 to 1383.0
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-19F at Month 34
|
34.1 Titers
Interval 18.4 to 63.2
|
48.4 Titers
Interval 25.9 to 90.6
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-19F at Mth34+D7
|
2231.5 Titers
Interval 1267.7 to 3927.9
|
5684.4 Titers
Interval 3647.8 to 8858.0
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-23F at Month 10
|
1414.6 Titers
Interval 827.9 to 2417.1
|
1984.8 Titers
Interval 1520.3 to 2591.3
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-23F at Month 34
|
458.5 Titers
Interval 186.3 to 1128.2
|
465.6 Titers
Interval 209.6 to 1034.0
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-23F at Mth34+D7
|
15688.3 Titers
Interval 10571.2 to 23282.4
|
13812.6 Titers
Interval 9566.0 to 19944.4
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.
Outcome measures
| Measure |
Unprimed Group
n=59 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-14 at PRE
|
252.5 Titers
Interval 138.1 to 461.5
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-14 at Day 7
|
3948.7 Titers
Interval 2958.9 to 5269.5
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-14 at Month 3
|
4978.9 Titers
Interval 3857.8 to 6425.9
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-1 at PRE
|
4 Titers
Interval 4.0 to 4.0
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-1 at Day 7
|
441.1 Titers
Interval 302.4 to 643.4
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-1 at Month 3
|
103 Titers
Interval 67.6 to 157.0
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-4 at PRE
|
5.1 Titers
Interval 3.9 to 6.7
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-4 at Day 7
|
9675.9 Titers
Interval 7792.2 to 12014.9
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-4 at Month 3
|
2687.5 Titers
Interval 2165.0 to 3336.1
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-5 at PRE
|
4.1 Titers
Interval 3.9 to 4.5
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-5 at Day 7
|
330 Titers
Interval 200.5 to 543.0
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-5 at Month 3
|
127.6 Titers
Interval 92.7 to 175.6
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-6B at PRE
|
21.6 Titers
Interval 11.0 to 42.4
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-6B at Day 7
|
438.2 Titers
Interval 208.4 to 921.5
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-6B at Month 3
|
1040.9 Titers
Interval 652.8 to 1659.5
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-7F at PRE
|
644.2 Titers
Interval 355.5 to 1167.3
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-7F at Day 7
|
11048.4 Titers
Interval 8626.3 to 14150.5
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-7F at Month 3
|
6213.1 Titers
Interval 4793.1 to 8053.7
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-9V at PRE
|
103.1 Titers
Interval 53.8 to 197.6
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-9V at Day 7
|
12217.8 Titers
Interval 9359.1 to 15949.8
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-9V at Month 3
|
6085.2 Titers
Interval 4718.5 to 7847.9
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-18C at PRE
|
6.1 Titers
Interval 4.0 to 9.3
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-18C at Day 7
|
3905.6 Titers
Interval 2648.0 to 5760.4
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-18C at Month 3
|
3984.5 Titers
Interval 3187.9 to 4980.2
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-19F at PRE
|
8.4 Titers
Interval 5.6 to 12.7
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-19F at Day 7
|
367.5 Titers
Interval 202.7 to 666.5
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-19F at Month 3
|
1772.5 Titers
Interval 1285.9 to 2443.3
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-23F at PRE
|
265.3 Titers
Interval 121.5 to 579.6
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-23F at Day 7
|
5059 Titers
Interval 3800.6 to 6734.0
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Opsono-23F at Month 3
|
5095.5 Titers
Interval 3992.3 to 6503.6
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and19A (ANTI-6A and19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=50 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=57 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-6A at Month 10
|
0.31 μg/mL
Interval 0.2 to 0.48
|
0.51 μg/mL
Interval 0.33 to 0.77
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-6A at Month 34
|
0.26 μg/mL
Interval 0.16 to 0.42
|
0.45 μg/mL
Interval 0.28 to 0.71
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-6A at Mth34+D7
|
1.13 μg/mL
Interval 0.71 to 1.79
|
2 μg/mL
Interval 1.32 to 3.03
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-19A at Month 10
|
0.8 μg/mL
Interval 0.53 to 1.2
|
0.75 μg/mL
Interval 0.5 to 1.12
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-19A at Month 34
|
0.31 μg/mL
Interval 0.2 to 0.49
|
0.26 μg/mL
Interval 0.17 to 0.4
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-19A at Mth34+D7
|
3.44 μg/mL
Interval 2.3 to 5.15
|
3.76 μg/mL
Interval 2.47 to 5.73
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=60 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Anti-6A at PRE
|
0.11 μg/mL
Interval 0.08 to 0.16
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Anti-6A at Day 7
|
0.15 μg/mL
Interval 0.11 to 0.21
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Anti-6A at Month 3
|
0.58 μg/mL
Interval 0.42 to 0.79
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Anti-19A at PRE
|
0.13 μg/mL
Interval 0.09 to 0.2
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Anti-19A at Day 7
|
0.32 μg/mL
Interval 0.21 to 0.49
|
—
|
—
|
|
Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Anti-19A at Month 3
|
1.97 μg/mL
Interval 1.46 to 2.65
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=50 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=57 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-6A at Month 10
|
42 Participants
|
51 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-6A at Month 34
|
43 Participants
|
51 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-6A at Mth34+D7
|
48 Participants
|
55 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-19A at Month 10
|
48 Participants
|
54 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-19A at Month 34
|
44 Participants
|
50 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-19A at Mth34+D7
|
50 Participants
|
55 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=60 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-6A at PRE
|
47 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-6A at Day 7
|
50 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-6A at Month 3
|
59 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-19A at PRE
|
41 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-19A at Day 7
|
55 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Anti-19A at Month 3
|
60 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7);Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=50 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=57 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;
Anti-6A at Month 10
|
31 Participants
|
43 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;
Anti-6A at Month 34
|
22 Participants
|
38 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;
Anti-6A at Mth34+D7
|
44 Participants
|
51 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;
Anti-19A at Month 10
|
41 Participants
|
45 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;
Anti-19A at Month 34
|
26 Participants
|
30 Participants
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;
Anti-19A at Mth34+D7
|
47 Participants
|
54 Participants
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Antibodies assessed were those against the vaccine pneumococcal serotypes 6A and 19A (ANTI-6A and 19A) and were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (μg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.20 μg/mL.
Outcome measures
| Measure |
Unprimed Group
n=60 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group
Anti-19A at Month 3
|
58 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group
Anti-6A at PRE
|
13 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group
Anti-6A at Day 7
|
24 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group
Anti-6A at Month 3
|
49 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group
Anti-19A at PRE
|
22 Participants
|
—
|
—
|
|
Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group
Anti-19A at Day 7
|
33 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8
Outcome measures
| Measure |
Unprimed Group
n=48 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=55 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-6A at Month 10
|
60.9 Titers
Interval 25.9 to 143.1
|
135 Titers
Interval 68.3 to 267.0
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-6A at Month 34
|
64.3 Titers
Interval 27.1 to 152.7
|
81.5 Titers
Interval 39.7 to 167.5
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-6A at Mth34+D7
|
1639.4 Titers
Interval 958.6 to 2803.9
|
1267.3 Titers
Interval 713.8 to 2250.0
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-19A at Month 10
|
14.4 Titers
Interval 7.6 to 27.3
|
35.9 Titers
Interval 18.0 to 71.6
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-19A at Month 34
|
8 Titers
Interval 5.2 to 12.2
|
8.6 Titers
Interval 5.6 to 13.4
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Opsono-19A at Mth34+D7
|
799.3 Titers
Interval 372.8 to 1713.4
|
1871.6 Titers
Interval 975.8 to 3589.8
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.
Outcome measures
| Measure |
Unprimed Group
n=58 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Opsono-19A at Day 7
|
211.9 Titers
Interval 99.9 to 449.7
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Opsono-6A at PRE
|
36.3 Titers
Interval 18.9 to 69.6
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Opsono-6A at Day
|
389.6 Titers
Interval 215.2 to 705.5
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Opsono-6A at Month
|
715.2 Titers
Interval 487.3 to 1049.6
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Opsono-19A at PRE
|
5.4 Titers
Interval 4.2 to 6.9
|
—
|
—
|
|
Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Opsono-19A at Month 3
|
406.4 Titers
Interval 227.3 to 726.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 month after booster dose (Month 10) - in primary study (105539), pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
ANTI-PD concentrations were expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status was defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.
Outcome measures
| Measure |
Unprimed Group
n=50 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=57 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Concentrations of Antibodies Against Protein D (ANTI-PD) in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-PD at Month 10
|
1438 EL.U/mL
Interval 1018.9 to 2029.4
|
2241.3 EL.U/mL
Interval 1752.5 to 2866.3
|
—
|
|
Concentrations of Antibodies Against Protein D (ANTI-PD) in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-PD at Month 34
|
301.6 EL.U/mL
Interval 219.5 to 414.3
|
461.3 EL.U/mL
Interval 351.1 to 606.0
|
—
|
|
Concentrations of Antibodies Against Protein D (ANTI-PD) in the Synflorix™ Group 1 and Synflorix™ Group 2
Anti-PD at Mth34+D7
|
1724.1 EL.U/mL
Interval 1299.4 to 2287.5
|
2113.2 EL.U/mL
Interval 1651.2 to 2704.5
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
ANTI-PD concentrations were expressed as geometric mean concentrations (GMCs), in enzyme-linked immunosorbent assay (ELISA) unit per milliliter (EL.U/mL). Seropositivity status was defined as Anti-PD antibody concentrations ≥ 100 EL.U/mL.
Outcome measures
| Measure |
Unprimed Group
n=60 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Concentrations of Antibodies Against Protein D (ANTI-PD) in the Unprimed Group
Anti-PD at PRE
|
110.9 EL.U/mL
Interval 88.8 to 138.6
|
—
|
—
|
|
Concentrations of Antibodies Against Protein D (ANTI-PD) in the Unprimed Group
Anti-PD at Day 7
|
536.3 EL.U/mL
Interval 390.7 to 736.2
|
—
|
—
|
|
Concentrations of Antibodies Against Protein D (ANTI-PD) in the Unprimed Group
Anti-PD at Month 3
|
960.4 EL.U/mL
Interval 752.7 to 1225.5
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to and 7-10 days post- additional dose.
Outcome measures
| Measure |
Unprimed Group
n=10 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=13 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2
18C PS at Month 34
|
377 Participants
Standard Deviation 459.3
|
424.9 Participants
Standard Deviation 668.2
|
—
|
|
Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2
18C PS at Mth34+D7
|
1205.3 Participants
Standard Deviation 661.4
|
2891.2 Participants
Standard Deviation 2274.5
|
—
|
|
Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2
19F PS at Month 34
|
163.1 Participants
Standard Deviation 306.4
|
635.4 Participants
Standard Deviation 1196.6
|
—
|
|
Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2
19F PS at Mth34+D7
|
856.7 Participants
Standard Deviation 1211.7
|
1626 Participants
Standard Deviation 1760.5
|
—
|
|
Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2
23F PS at Month 34
|
174.2 Participants
Standard Deviation 285
|
212.2 Participants
Standard Deviation 320.8
|
—
|
|
Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2
23F PS at Mth34+D7
|
120.1 Participants
Standard Deviation 92
|
351.9 Participants
Standard Deviation 400.4
|
—
|
|
Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2
6B PS at Month 34
|
136.1 Participants
Standard Deviation 131.8
|
508.5 Participants
Standard Deviation 606.3
|
—
|
|
Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2
6B PS at Mth34+D7
|
153.1 Participants
Standard Deviation 216
|
469.7 Participants
Standard Deviation 554.5
|
—
|
|
Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2
C-PS at Month 34
|
246.3 Participants
Standard Deviation 247.3
|
751.2 Participants
Standard Deviation 790.5
|
—
|
|
Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2
C-PS at Mth34+D7
|
167.6 Participants
Standard Deviation 92
|
600.5 Participants
Standard Deviation 488.8
|
—
|
SECONDARY outcome
Timeframe: Pre-vaccination (PRE/ Day 0) and one week after dose 1 (Day 7)Population: The According-To-Protocol (ATP) cohort for immunogenicity included all evaluable subjects with available immunogenicity data. This included subjects for whom assay results were available for antibodies against at least one pneumococcal vaccine serotype or protein D after vaccination.
Quantification of memory B-cells that produce antibodies against vaccine pneumococcal serotypes (PS) 6B, 18C, 19F, 23F and C-PS (Elispot assay), prior to, and 7-10 days post-dose 1.
Outcome measures
| Measure |
Unprimed Group
n=13 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number of Subjects With B-cells Detection in the Unprimed Group
18C PS at PRE
|
246.5 Participants
Standard Deviation 310.8
|
—
|
—
|
|
Number of Subjects With B-cells Detection in the Unprimed Group
18C PS at Day 7
|
3014.2 Participants
Standard Deviation 4168.4
|
—
|
—
|
|
Number of Subjects With B-cells Detection in the Unprimed Group
19F PS at PRE
|
306.4 Participants
Standard Deviation 423.1
|
—
|
—
|
|
Number of Subjects With B-cells Detection in the Unprimed Group
19F PS at Day 7
|
599.8 Participants
Standard Deviation 643.8
|
—
|
—
|
|
Number of Subjects With B-cells Detection in the Unprimed Group
23F PS at PRE
|
280 Participants
Standard Deviation 492.2
|
—
|
—
|
|
Number of Subjects With B-cells Detection in the Unprimed Group
23F PS at Day 7
|
450 Participants
Standard Deviation 529.4
|
—
|
—
|
|
Number of Subjects With B-cells Detection in the Unprimed Group
6B PS at PRE
|
159.8 Participants
Standard Deviation 220.7
|
—
|
—
|
|
Number of Subjects With B-cells Detection in the Unprimed Group
6B PS at Day 7
|
432.4 Participants
Standard Deviation 478.3
|
—
|
—
|
|
Number of Subjects With B-cells Detection in the Unprimed Group
C-PS at PRE
|
751.9 Participants
Standard Deviation 463
|
—
|
—
|
|
Number of Subjects With B-cells Detection in the Unprimed Group
C-PS at Day 7
|
789.2 Participants
Standard Deviation 751.1
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group1 and the Synflorix Group2 and across the 2 doses in the Unprimed GroupPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
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 greater than (\>) 30 millimeters (mm).
Outcome measures
| Measure |
Unprimed Group
n=51 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=59 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
n=62 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Pain
|
41 Participants
|
44 Participants
|
49 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Redness
|
34 Participants
|
35 Participants
|
41 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness
|
9 Participants
|
12 Participants
|
15 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Any Swelling
|
28 Participants
|
27 Participants
|
30 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling
|
5 Participants
|
9 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period with the Synflorix™ vaccine, following the additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Assessed solicited general symptoms were drowsiness, irritability/ fussiness (Irr./Fuss.), loss of appetite (Loss Appet.) and Fever (rectal temperature ≥ 38.0 °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 everyday activities. Grade 3 Irr./Fuss. = crying that could not be comforted/ prevented normal everyday activities. Grade 3 loss of appetite = not eating at all. Grade 3 fever = rectal temperature \> 40.0°C.
Outcome measures
| Measure |
Unprimed Group
n=51 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=59 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
n=62 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss Appet.
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness
|
20 Participants
|
23 Participants
|
17 Participants
|
|
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness
|
20 Participants
|
23 Participants
|
17 Participants
|
|
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Fever
|
9 Participants
|
5 Participants
|
8 Participants
|
|
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Fever
|
9 Participants
|
4 Participants
|
7 Participants
|
|
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Irr./Fuss.
|
20 Participants
|
27 Participants
|
21 Participants
|
|
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irr./Fuss.
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Irr./Fuss.
|
20 Participants
|
25 Participants
|
20 Participants
|
|
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Any Loss Appet.
|
12 Participants
|
13 Participants
|
14 Participants
|
|
Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Related Loss Appet.
|
12 Participants
|
13 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) period post vaccination, with the Synflorix™ vaccine, following the additional dose in the Synflorix group1 and the Synflorix Group 2 and across the 2 doses in the Unprimed GroupPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
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. Any = occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
Outcome measures
| Measure |
Unprimed Group
n=51 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=59 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
n=62 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number (%) of Subjects With Unsolicited Adverse Events
|
24 Participants
|
24 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: During the 31-day period following vaccination periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
A serious adverse event (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.
Outcome measures
| Measure |
Unprimed Group
n=51 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
Synflorix™ Group 2
n=59 Participants
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Unprimed Group
n=62 Participants
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Number (%) of Subjects With Serious Adverse Events
|
1 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Synflorix™ Group 1
Serious events: 1 serious events
Other events: 41 other events
Deaths: 1 deaths
Synflorix™ Group 2
Serious events: 1 serious events
Other events: 44 other events
Deaths: 1 deaths
Unprimed Group
Serious events: 1 serious events
Other events: 49 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Synflorix™ Group 1
n=51 participants at risk
Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Synflorix™ Group 2
n=59 participants at risk
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
|
Unprimed Group
n=62 participants at risk
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
0.00%
0/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
0.00%
0/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
0.00%
0/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
1.6%
1/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
1.7%
1/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
0.00%
0/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
Other adverse events
| Measure |
Synflorix™ Group 1
n=51 participants at risk
Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
|
Synflorix™ Group 2
n=59 participants at risk
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
|
Unprimed Group
n=62 participants at risk
Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.
|
|---|---|---|---|
|
General disorders
Pyrexia
|
13.7%
7/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
13.6%
8/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
11.3%
7/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
General disorders
Swelling
|
54.9%
28/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
45.8%
27/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
48.4%
30/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
1/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
6.8%
4/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
19.4%
12/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
General disorders
Pain
|
80.4%
41/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
74.6%
44/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
79.0%
49/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
8.5%
5/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
8.1%
5/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
Psychiatric disorders
Irritability
|
39.2%
20/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
45.8%
27/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
33.9%
21/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
General disorders
Redness
|
66.7%
34/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
59.3%
35/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
66.1%
41/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
General disorders
Drowsiness
|
39.2%
20/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
39.0%
23/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
27.4%
17/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
General disorders
Fever (Rectally, ≥ 38.0°C)
|
17.6%
9/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
8.5%
5/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
12.9%
8/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
General disorders
Loss of appetite
|
23.5%
12/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
22.0%
13/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
22.6%
14/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.9%
2/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
5.1%
3/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
6.5%
4/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
Infections and infestations
Viral infection
|
0.00%
0/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
1.7%
1/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
9.7%
6/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
3/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
5.1%
3/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
3.2%
2/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
|
Infections and infestations
Bronchitis
|
3.9%
2/51 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
5.1%
3/59 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
9.7%
6/62 • Solicited symptoms during the 4-day post-vaccination period and unsolicited AEs and SAEs: during the 31-day post-vaccination period, following additional dose in the Synflorix Group 1 and the Synflorix Group 2 and across the 2 doses in the Unprimed Group.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER