Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00792909
Recruitment Status : Completed
First Posted : November 18, 2008
Results First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Streptococcal
Intervention Biological: Pneumococcal conjugate vaccine GSK1024850A
Enrollment 172
Recruitment Details 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.
Pre-assignment Details During the screening the following steps occurred: check for inclusion/ exclusion criteria, contraindications/ precautions, medical history of the subjects and signing informed consent forms.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2 Unprimed Group
Hide Arm/Group Description Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age. Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age, 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.
Period Title: Overall Study
Started 51 59 62
Completed 51 58 62
Not Completed 0 1 0
Reason Not Completed
Withdrawal by Subject             0             1             0
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2 Unprimed Group Total
Hide Arm/Group Description Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age. Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age, 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 of all reporting groups
Overall Number of Baseline Participants 51 59 62 172
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Geometric Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 51 participants 59 participants 62 participants 172 participants
38.2  (1.83) 38.0  (1.81) 40.1  (2.64) 38.82  (2.35)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 59 participants 62 participants 172 participants
Female
25
  49.0%
25
  42.4%
31
  50.0%
81
  47.1%
Male
26
  51.0%
34
  57.6%
31
  50.0%
91
  52.9%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 59 participants 62 participants 172 participants
White – Caucasian / European heritage
50
  98.0%
59
 100.0%
59
  95.2%
168
  97.7%
Asian - central/ south Asian heritage
0
   0.0%
0
   0.0%
1
   1.6%
1
   0.6%
Asian - east Asian heritage
0
   0.0%
0
   0.0%
1
   1.6%
1
   0.6%
Asian - south east Asian heritage
0
   0.0%
0
   0.0%
1
   1.6%
1
   0.6%
Other
1
   2.0%
0
   0.0%
0
   0.0%
1
   0.6%
1.Primary Outcome
Title 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
Hide Description 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.
Time Frame Pre-vaccination (PRE/ Day 0)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unprimed Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Anti-1 at PRE
0.06
(0.05 to 0.08)
Anti-4 at PRE
0.04
(0.03 to 0.05)
Anti-5 at PRE
0.07
(0.05 to 0.09)
Anti-6B at PRE
0.1
(0.07 to 0.13)
Anti-7F at PRE
0.08
(0.05 to 0.12)
Anti-9V at PRE
0.05
(0.04 to 0.07)
Anti-14 at PRE
0.25
(0.16 to 0.38)
Anti-18C at PRE
0.06
(0.04 to 0.08)
Anti-19F at PRE
0.23
(0.14 to 0.38)
Anti-23F at PRE
0.06
(0.04 to 0.08)
2.Primary Outcome
Title 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
Hide Description 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.
Time Frame One week after dose 1 (Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unprimed Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Anti-1 at Day 7 Number Analyzed 60 participants
0.6
(0.47 to 0.76)
Anti-4 at Day 7 Number Analyzed 60 participants
2.37
(1.91 to 2.94)
Anti-5 at Day 7 Number Analyzed 60 participants
0.45
(0.34 to 0.59)
Anti-6B at Day 7 Number Analyzed 58 participants
0.2
(0.14 to 0.29)
Anti-7F at Day 7 Number Analyzed 60 participants
0.92
(0.67 to 1.25)
Anti-9V at Day 7 Number Analyzed 60 participants
0.33
(0.23 to 0.48)
Anti-14 at Day 7 Number Analyzed 60 participants
0.54
(0.34 to 0.86)
Anti-18C at Day 7 Number Analyzed 59 participants
1.45
(1.01 to 2.06)
Anti-19F at Day 7 Number Analyzed 59 participants
1.82
(1.27 to 2.6)
Anti-23F at Day 7 Number Analyzed 60 participants
0.1
(0.07 to 0.15)
3.Primary Outcome
Title 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
Hide Description 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.
Time Frame One month after dose 2 (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unprimed Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Anti-1 at Month 3
2.81
(2.25 to 3.51)
Anti-4 at Month 3
8.44
(7.16 to 9.94)
Anti-5 at Month 3
3.54
(2.96 to 4.23)
Anti-6B at Month 3
1.11
(0.84 to 1.46)
Anti-7F at Month 3
6.1
(4.99 to 7.46)
Anti-9V at Month 3
2.22
(1.74 to 2.82)
Anti-14 at Month 3
6.48
(4.98 to 8.44)
Anti-18C at Month 3
22.28
(18.14 to 27.36)
Anti-19F at Month 3
17.03
(13.38 to 21.68)
Anti-23F at Month 3
1.09
(0.81 to 1.45)
4.Primary Outcome
Title 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
Hide Description 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.
Time Frame 1 month after booster dose (Month 10) – in primary study (105539)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Overall Number of Participants Analyzed 50 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Anti-1 at Month 10
1.91
(1.52 to 2.42)
1.87
(1.49 to 2.33)
Anti-4 at Month 10
2.97
(2.34 to 3.77)
3.2
(2.62 to 3.91)
Anti-5 at Month 10
2.71
(2.15 to 3.41)
3.01
(2.4 to 3.76)
Anti-6B at Month 10
0.9
(0.59 to 1.36)
1.62
(1.16 to 2.27)
Anti-7F at Month 10
2.94
(2.4 to 3.59)
3.88
(3.23 to 4.65)
Anti-9V at Month 10
2.59
(2.03 to 3.31)
3.81
(3.11 to 4.67)
Anti-14 at Month 10
3.91
(3.05 to 5)
5.22
(4.22 to 6.46)
Anti-18C at Month 10
4.87
(3.77 to 6.29)
5.52
(4.2 to 7.26)
Anti-19F at Month 10
6.68
(5.2 to 8.59)
6.6
(5.16 to 8.46)
Anti-23F at Month 10
2.12
(1.52 to 2.97)
2.67
(1.99 to 3.59)
5.Primary Outcome
Title 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
Hide Description 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.
Time Frame Pre-additional dose at Month 34 in the current study (Month 34)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
Overall Number of Participants Analyzed 50 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Anti-1 at Month 34 Number Analyzed 49 participants 57 participants
0.13
(0.1 to 0.17)
0.17
(0.14 to 0.22)
Anti-4 at Month 34 Number Analyzed 48 participants 54 participants
0.15
(0.1 to 0.23)
0.19
(0.14 to 0.25)
Anti-5 at Month 34 Number Analyzed 50 participants 57 participants
0.24
(0.19 to 0.31)
0.33
(0.26 to 0.42)
Anti-6B at Month 34 Number Analyzed 48 participants 57 participants
0.5
(0.29 to 0.88)
1.01
(0.62 to 1.64)
Anti-7F at Month 34 Number Analyzed 49 participants 56 participants
0.33
(0.24 to 0.46)
0.51
(0.42 to 0.61)
Anti-9V at Month 34 Number Analyzed 50 participants 57 participants
0.24
(0.18 to 0.33)
0.49
(0.34 to 0.69)
Anti-14 at Month 34 Number Analyzed 50 participants 56 participants
0.62
(0.39 to 0.97)
1.1
(0.69 to 1.75)
Anti-18C at Month 34 Number Analyzed 50 participants 56 participants
0.37
(0.26 to 0.54)
0.49
(0.35 to 0.7)
Anti-19F at Month 34 Number Analyzed 47 participants 56 participants
1.42
(0.8 to 2.51)
1.44
(0.82 to 2.53)
Anti-23F at Month 34 Number Analyzed 49 participants 56 participants
0.41
(0.23 to 0.71)
0.67
(0.41 to 1.11)
6.Primary Outcome
Title 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
Hide Description 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.
Time Frame One week after vaccination at Month 34+7 days (Mth34+D7)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
Overall Number of Participants Analyzed 50 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Anti-1 at Mth34+D7 Number Analyzed 50 participants 55 participants
4.06
(3.2 to 5.15)
4.72
(3.77 to 5.92)
Anti-4 at Mth34+D7 Number Analyzed 49 participants 55 participants
7.54
(5.98 to 9.5)
9.97
(7.68 to 12.95)
Anti-5 at Mth34+D7 Number Analyzed 50 participants 55 participants
5.38
(4.09 to 7.08)
7.07
(5.51 to 9.09)
Anti-6B at Mth34+D7 Number Analyzed 50 participants 55 participants
4
(2.82 to 5.69)
6.33
(4.75 to 8.45)
Anti-7F at Mth34+D7 Number Analyzed 50 participants 55 participants
6.18
(5.05 to 7.56)
7.27
(5.87 to 9.01)
Anti-9V at Mth34+D7 Number Analyzed 50 participants 55 participants
7.48
(5.88 to 9.51)
10.17
(7.86 to 13.16)
Anti-14 at Mth34+D7 Number Analyzed 50 participants 55 participants
13.42
(9.7 to 18.55)
19.67
(14.97 to 25.84)
Anti-18C at Mth34+D7 Number Analyzed 50 participants 55 participants
17.12
(12.77 to 22.94)
22.62
(17.58 to 29.11)
Anti-19F at Mth34+D7 Number Analyzed 50 participants 55 participants
20.28
(15.71 to 26.19)
30.55
(24.32 to 38.37)
Anti-23F at Mth34+D7 Number Analyzed 50 participants 55 participants
6.23
(4.34 to 8.94)
8.42
(6.38 to 11.11)
7.Secondary Outcome
Title 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
Hide Description 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..
Time Frame 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);
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Overall Number of Participants Analyzed 50 57
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-1 at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-1 at Month 34 Number Analyzed 49 participants 57 participants
43
  87.8%
55
  96.5%
Anti-1 at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-4 at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-4 at Month 34 Number Analyzed 48 participants 54 participants
41
  85.4%
54
 100.0%
Anti-4 at Mth34+D7 Number Analyzed 49 participants 55 participants
49
 100.0%
55
 100.0%
Anti-5 at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-5 at Month 34 Number Analyzed 50 participants 57 participants
49
  98.0%
57
 100.0%
Anti-5 at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-6B at Month 10 Number Analyzed 50 participants 57 participants
45
  90.0%
54
  94.7%
Anti-6B at Month 34 Number Analyzed 48 participants 57 participants
43
  89.6%
56
  98.2%
Anti-6B at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-7F at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-7F at Month 34 Number Analyzed 49 participants 56 participants
47
  95.9%
56
 100.0%
Anti-7F at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-9V at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-9V at Month 34 Number Analyzed 50 participants 57 participants
48
  96.0%
56
  98.2%
Anti-9V at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-14 at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-14 at Month 34 Number Analyzed 50 participants 56 participants
50
 100.0%
56
 100.0%
Anti-14 at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-18C at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-18C at Month 34 Number Analyzed 50 participants 56 participants
48
  96.0%
56
 100.0%
Anti-18C at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-19F at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-19F at Month 34 Number Analyzed 47 participants 56 participants
47
 100.0%
56
 100.0%
Anti-19F at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-23F at Month 10 Number Analyzed 50 participants 57 participants
49
  98.0%
56
  98.2%
Anti-23F at Month 34 Number Analyzed 49 participants 56 participants
43
  87.8%
56
 100.0%
Anti-23F at Mth34+D7 Number Analyzed 50 participants 55 participants
49
  98.0%
55
 100.0%
8.Secondary Outcome
Title 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;
Hide Description 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.
Time Frame Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unprimed Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-1 at PRE Number Analyzed 60 participants
34
  56.7%
Anti-1 at Day 7 Number Analyzed 60 participants
60
 100.0%
Anti-1 at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-4 at PRE Number Analyzed 60 participants
9
  15.0%
Anti-4 at Day 7 Number Analyzed 60 participants
60
 100.0%
Anti-4 at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-5 at PRE Number Analyzed 60 participants
37
  61.7%
Anti-5 at Day 7 Number Analyzed 60 participants
60
 100.0%
Anti-5 at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-6B at PRE Number Analyzed 60 participants
40
  66.7%
Anti-6B at Day 7 Number Analyzed 58 participants
49
  84.5%
Anti-6B at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-7F at PRE Number Analyzed 60 participants
29
  48.3%
Anti-7F at Day 7 Number Analyzed 60 participants
60
 100.0%
Anti-7F at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-9V at PRE Number Analyzed 60 participants
21
  35.0%
Anti-9V at Day 7 Number Analyzed 60 participants
58
  96.7%
Anti-9V at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-14 at PRE Number Analyzed 60 participants
56
  93.3%
Anti-14 at Day 7 Number Analyzed 60 participants
58
  96.7%
Anti-14 at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-18C at PRE Number Analyzed 60 participants
23
  38.3%
Anti-18C at Day 7 Number Analyzed 59 participants
59
 100.0%
Anti-18C at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-19F at PRE Number Analyzed 60 participants
44
  73.3%
Anti-19F at Day 7 Number Analyzed 59 participants
59
 100.0%
Anti-19F at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-23F at PRE Number Analyzed 60 participants
23
  38.3%
Anti-23F at Day 7 Number Analyzed 60 participants
39
  65.0%
Anti-23F at Month 3 Number Analyzed 60 participants
60
 100.0%
9.Secondary Outcome
Title 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
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
Overall Number of Participants Analyzed 50 57
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-1 at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-1 at Month 34 Number Analyzed 49 participants 57 participants
16
  32.7%
28
  49.1%
Anti-1 at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-4 at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-4 at Month 34 Number Analyzed 48 participants 54 participants
12
  25.0%
20
  37.0%
Anti-4 at Mth34+D7 Number Analyzed 49 participants 55 participants
49
 100.0%
55
 100.0%
Anti-5 at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-5 at Month 34 Number Analyzed 50 participants 57 participants
31
  62.0%
35
  61.4%
Anti-5 at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-6B at Month 10 Number Analyzed 50 participants 57 participants
44
  88.0%
54
  94.7%
Anti-6B at Month 34 Number Analyzed 48 participants 57 participants
29
  60.4%
44
  77.2%
Anti-6B at Mth34+D7 Number Analyzed 50 participants 55 participants
49
  98.0%
55
 100.0%
Anti-7F at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-7F at Month 34 Number Analyzed 49 participants 56 participants
37
  75.5%
53
  94.6%
Anti-7F at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-9V at Month 10 Number Analyzed 50 participants 57 participants
49
  98.0%
57
 100.0%
Anti-9V at Month 34 Number Analyzed 50 participants 57 participants
27
  54.0%
45
  78.9%
Anti-9V at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-14 at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
57
 100.0%
Anti-14 at Month 34 Number Analyzed 50 participants 56 participants
37
  74.0%
49
  87.5%
Anti-14 at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-18C at Month 10 Number Analyzed 50 participants 57 participants
50
 100.0%
56
  98.2%
Anti-18C at Month 34 Number Analyzed 50 participants 56 participants
35
  70.0%
44
  78.6%
Anti-18C at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-19F at Month 10 Number Analyzed 50 participants 57 participants
49
  98.0%
56
  98.2%
Anti-19F at Month 34 Number Analyzed 47 participants 56 participants
39
  83.0%
47
  83.9%
Anti-19F at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
Anti-23F at Month 10 Number Analyzed 50 participants 57 participants
47
  94.0%
55
  96.5%
Anti-23F at Month 34 Number Analyzed 49 participants 56 participants
29
  59.2%
36
  64.3%
Anti-23F at Mth34+D7 Number Analyzed 50 participants 55 participants
49
  98.0%
55
 100.0%
10.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3);
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unprimed Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-1 at PRE Number Analyzed 60 participants
10
  16.7%
Anti-1 at Day 7 Number Analyzed 60 participants
54
  90.0%
Anti-1 at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-4 at PRE Number Analyzed 60 participants
4
   6.7%
Anti-4 at Day 7 Number Analyzed 60 participants
60
 100.0%
Anti-4 at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-5 at PRE Number Analyzed 60 participants
9
  15.0%
Anti-5 at Day 7 Number Analyzed 60 participants
47
  78.3%
Anti-5 at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-6B at PRE Number Analyzed 60 participants
19
  31.7%
Anti-6B at Day 7 Number Analyzed 58 participants
29
  50.0%
Anti-6B at Month 3 Number Analyzed 60 participants
56
  93.3%
Anti-7F at PRE Number Analyzed 60 participants
11
  18.3%
Anti-7F at Day 7 Number Analyzed 60 participants
54
  90.0%
Anti-7F at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-9V at PRE Number Analyzed 60 participants
7
  11.7%
Anti-9V at Day 7 Number Analyzed 60 participants
40
  66.7%
Anti-9V at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-14 at PRE Number Analyzed 60 participants
27
  45.0%
Anti-14 at Day 7 Number Analyzed 60 participants
42
  70.0%
Anti-14 at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-18C at PRE Number Analyzed 60 participants
8
  13.3%
Anti-18C at Day 7 Number Analyzed 59 participants
56
  94.9%
Anti-18C at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-19F at PRE Number Analyzed 60 participants
29
  48.3%
Anti-19F at Day 7 Number Analyzed 59 participants
57
  96.6%
Anti-19F at Month 3 Number Analyzed 60 participants
60
 100.0%
Anti-23F at PRE Number Analyzed 60 participants
11
  18.3%
Anti-23F at Day 7 Number Analyzed 60 participants
16
  26.7%
Anti-23F at Month 3 Number Analyzed 60 participants
56
  93.3%
11.Secondary Outcome
Title 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
Hide Description Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
Overall Number of Participants Analyzed 48 55
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Opsono-1 at Month 10 Number Analyzed 44 participants 53 participants
243.9
(137.3 to 433.3)
176.9
(104 to 301)
Opsono-1 at Month 34 Number Analyzed 47 participants 55 participants
5.5
(4.3 to 7)
6.2
(4.9 to 8)
Opsono-1 at Mth34+D7 Number Analyzed 48 participants 55 participants
2342.2
(1788.8 to 3066.7)
2321.5
(1827.1 to 2949.7)
Opsono-4 at Month 10 Number Analyzed 43 participants 55 participants
937.6
(600.8 to 1463.4)
1347
(1068.8 to 1697.7)
Opsono-4 at Month 34 Number Analyzed 44 participants 52 participants
9.6
(4.9 to 18.8)
9.5
(5.8 to 15.6)
Opsono-4 at Mth34+D7 Number Analyzed 48 participants 53 participants
13247.5
(9898 to 17730.4)
17732.6
(13218.8 to 23787.7)
Opsono-5 at Month 10 Number Analyzed 45 participants 54 participants
154
(94.2 to 251.6)
181.2
(125.4 to 262)
Opsono-5 at Month 34 Number Analyzed 47 participants 54 participants
6.7
(5.2 to 8.6)
8
(6.1 to 10.6)
Opsono-5 at Mth34+D7 Number Analyzed 48 participants 55 participants
991.5
(769.8 to 1277.1)
1221.1
(912.4 to 1634.2)
Opsono-6B at Month 10 Number Analyzed 44 participants 51 participants
292.2
(147.1 to 580.3)
458.8
(254.8 to 825.9)
Opsono-6B at Month 34 Number Analyzed 42 participants 54 participants
61.5
(22.8 to 165.6)
126.3
(59.4 to 268.5)
Opsono-6B at Mth34+D7 Number Analyzed 47 participants 54 participants
3312.9
(1751.2 to 6267.2)
3136
(1730 to 5684.6)
Opsono-7F at Month 10 Number Analyzed 44 participants 53 participants
2257.8
(1601.9 to 3182.3)
3856.8
(2890.4 to 5146.2)
Opsono-7F at Month 34 Number Analyzed 45 participants 53 participants
1329.1
(778.8 to 2268.4)
1225.5
(842.5 to 1782.6)
Opsono-7F at Mth34+D7 Number Analyzed 48 participants 52 participants
20779
(14616.7 to 29539.1)
22461.4
(16876.9 to 29893.7)
Opsono-9V at Month 10 Number Analyzed 44 participants 54 participants
1581.7
(1147.7 to 2179.9)
2013.9
(1565.3 to 2591)
Opsono-9V at Month 34 Number Analyzed 43 participants 53 participants
307.4
(210.3 to 449.4)
292.3
(221 to 386.6)
Opsono-9V at Mth34+D7 Number Analyzed 48 participants 52 participants
21193.6
(16100.3 to 27898.2)
19038.4
(14154.7 to 25607.2)
Opsono-14 at Month 10 Number Analyzed 35 participants 52 participants
1092.5
(691.9 to 1725)
1207.1
(961.4 to 1515.5)
Opsono-14 at Month 34 Number Analyzed 41 participants 49 participants
421.5
(258.8 to 686.5)
738.6
(540 to 1010.2)
Opsono-14 at Mth34+D7 Number Analyzed 48 participants 54 participants
14310
(10214 to 20048.7)
14670.9
(10258 to 20982.2)
Opsono-18C at Month 10 Number Analyzed 45 participants 54 participants
375.8
(251.3 to 562.1)
567.4
(422.8 to 761.5)
Opsono-18C at Month 34 Number Analyzed 45 participants 54 participants
11
(6 to 20.2)
17.7
(9.6 to 32.9)
Opsono-18C at Mth34+D7 Number Analyzed 48 participants 51 participants
6095.8
(4090.7 to 9083.8)
6448.7
(4258.7 to 9764.9)
Opsono-19F at Month 10 Number Analyzed 43 participants 54 participants
463.7
(318.3 to 675.6)
950.5
(653.3 to 1383)
Opsono-19F at Month 34 Number Analyzed 47 participants 55 participants
34.1
(18.4 to 63.2)
48.4
(25.9 to 90.6)
Opsono-19F at Mth34+D7 Number Analyzed 48 participants 55 participants
2231.5
(1267.7 to 3927.9)
5684.4
(3647.8 to 8858)
Opsono-23F at Month 10 Number Analyzed 45 participants 53 participants
1414.6
(827.9 to 2417.1)
1984.8
(1520.3 to 2591.3)
Opsono-23F at Month 34 Number Analyzed 43 participants 49 participants
458.5
(186.3 to 1128.2)
465.6
(209.6 to 1034)
Opsono-23F at Mth34+D7 Number Analyzed 48 participants 54 participants
15688.3
(10571.2 to 23282.4)
13812.6
(9566 to 19944.4)
12.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F in the Unprimed Group
Hide Description Seropositivity status was defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.
Time Frame Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unprimed Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 59
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Opsono-1 at PRE Number Analyzed 58 participants
4
(4 to 4)
Opsono-1 at Day 7 Number Analyzed 58 participants
441.1
(302.4 to 643.4)
Opsono-1 at Month 3 Number Analyzed 56 participants
103
(67.6 to 157)
Opsono-4 at PRE Number Analyzed 58 participants
5.1
(3.9 to 6.7)
Opsono-4 at Day 7 Number Analyzed 58 participants
9675.9
(7792.2 to 12014.9)
Opsono-4 at Month 3 Number Analyzed 56 participants
2687.5
(2165 to 3336.1)
Opsono-5 at PRE Number Analyzed 59 participants
4.1
(3.9 to 4.5)
Opsono-5 at Day 7 Number Analyzed 57 participants
330
(200.5 to 543)
Opsono-5 at Month 3 Number Analyzed 56 participants
127.6
(92.7 to 175.6)
Opsono-6B at PRE Number Analyzed 55 participants
21.6
(11 to 42.4)
Opsono-6B at Day 7 Number Analyzed 54 participants
438.2
(208.4 to 921.5)
Opsono-6B at Month 3 Number Analyzed 57 participants
1040.9
(652.8 to 1659.5)
Opsono-7F at PRE Number Analyzed 55 participants
644.2
(355.5 to 1167.3)
Opsono-7F at Day 7 Number Analyzed 57 participants
11048.4
(8626.3 to 14150.5)
Opsono-7F at Month 3 Number Analyzed 55 participants
6213.1
(4793.1 to 8053.7)
Opsono-9V at PRE Number Analyzed 55 participants
103.1
(53.8 to 197.6)
Opsono-9V at Day 7 Number Analyzed 57 participants
12217.8
(9359.1 to 15949.8)
Opsono-9V at Month 3 Number Analyzed 55 participants
6085.2
(4718.5 to 7847.9)
Opsono-14 at PRE Number Analyzed 55 participants
252.5
(138.1 to 461.5)
Opsono-14 at Day 7 Number Analyzed 57 participants
3948.7
(2958.9 to 5269.5)
Opsono-14 at Month 3 Number Analyzed 55 participants
4978.9
(3857.8 to 6425.9)
Opsono-18C at PRE Number Analyzed 53 participants
6.1
(4 to 9.3)
Opsono-18C at Day 7 Number Analyzed 57 participants
3905.6
(2648 to 5760.4)
Opsono-18C at Month 3 Number Analyzed 56 participants
3984.5
(3187.9 to 4980.2)
Opsono-19F at PRE Number Analyzed 48 participants
8.4
(5.6 to 12.7)
Opsono-19F at Day 7 Number Analyzed 57 participants
367.5
(202.7 to 666.5)
Opsono-19F at Month 3 Number Analyzed 56 participants
1772.5
(1285.9 to 2443.3)
Opsono-23F at PRE Number Analyzed 52 participants
265.3
(121.5 to 579.6)
Opsono-23F at Day 7 Number Analyzed 58 participants
5059
(3800.6 to 6734)
Opsono-23F at Month 3 Number Analyzed 57 participants
5095.5
(3992.3 to 6503.6)
13.Secondary Outcome
Title Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2
Hide Arm/Group Description:
Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
Overall Number of Participants Analyzed 50 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Anti-6A at Month 10 Number Analyzed 49 participants 57 participants
0.31
(0.2 to 0.48)
0.51
(0.33 to 0.77)
Anti-6A at Month 34 Number Analyzed 48 participants 55 participants
0.26
(0.16 to 0.42)
0.45
(0.28 to 0.71)
Anti-6A at Mth34+D7 Number Analyzed 50 participants 55 participants
1.13
(0.71 to 1.79)
2
(1.32 to 3.03)
Anti-19A at Month 10 Number Analyzed 50 participants 57 participants
0.8
(0.53 to 1.2)
0.75
(0.5 to 1.12)
Anti-19A at Month 34 Number Analyzed 49 participants 57 participants
0.31
(0.2 to 0.49)
0.26
(0.17 to 0.4)
Anti-19A at Mth34+D7 Number Analyzed 50 participants 55 participants
3.44
(2.3 to 5.15)
3.76
(2.47 to 5.73)
14.Secondary Outcome
Title Antibody Geometric Mean Concentrations (GMCs) Against the Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Hide Description 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.
Time Frame Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unprimed Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Anti-6A at PRE Number Analyzed 60 participants
0.11
(0.08 to 0.16)
Anti-6A at Day 7 Number Analyzed 60 participants
0.15
(0.11 to 0.21)
Anti-6A at Month 3 Number Analyzed 60 participants
0.58
(0.42 to 0.79)
Anti-19A at PRE Number Analyzed 60 participants
0.13
(0.09 to 0.2)
Anti-19A at Day 7 Number Analyzed 59 participants
0.32
(0.21 to 0.49)
Anti-19A at Month 3 Number Analyzed 60 participants
1.97
(1.46 to 2.65)
15.Secondary Outcome
Title Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
Overall Number of Participants Analyzed 50 57
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-6A at Month 10 Number Analyzed 49 participants 57 participants
42
  85.7%
51
  89.5%
Anti-6A at Month 34 Number Analyzed 48 participants 55 participants
43
  89.6%
51
  92.7%
Anti-6A at Mth34+D7 Number Analyzed 50 participants 55 participants
48
  96.0%
55
 100.0%
Anti-19A at Month 10 Number Analyzed 50 participants 57 participants
48
  96.0%
54
  94.7%
Anti-19A at Month 34 Number Analyzed 49 participants 57 participants
44
  89.8%
50
  87.7%
Anti-19A at Mth34+D7 Number Analyzed 50 participants 55 participants
50
 100.0%
55
 100.0%
16.Secondary Outcome
Title Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Unprimed Group
Hide Description 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.
Time Frame Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unprimed Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-6A at PRE Number Analyzed 60 participants
47
  78.3%
Anti-6A at Day 7 Number Analyzed 60 participants
50
  83.3%
Anti-6A at Month 3 Number Analyzed 60 participants
59
  98.3%
Anti-19A at PRE Number Analyzed 60 participants
41
  68.3%
Anti-19A at Day 7 Number Analyzed 59 participants
55
  93.2%
Anti-19A at Month 3 Number Analyzed 60 participants
60
 100.0%
17.Secondary Outcome
Title Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ the Cut-off in the Synflorix™ Group 1 and Synflorix™ Group 2;
Hide Description 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.
Time Frame 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);
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
Overall Number of Participants Analyzed 50 57
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-6A at Month 10 Number Analyzed 49 participants 57 participants
31
  63.3%
43
  75.4%
Anti-6A at Month 34 Number Analyzed 48 participants 55 participants
22
  45.8%
38
  69.1%
Anti-6A at Mth34+D7 Number Analyzed 50 participants 55 participants
44
  88.0%
51
  92.7%
Anti-19A at Month 10 Number Analyzed 50 participants 57 participants
41
  82.0%
45
  78.9%
Anti-19A at Month 34 Number Analyzed 49 participants 57 participants
26
  53.1%
30
  52.6%
Anti-19A at Mth34+D7 Number Analyzed 50 participants 55 participants
47
  94.0%
54
  98.2%
18.Secondary Outcome
Title Number of Subjects With Anti-pneumococcal Serotypes 6A and 19A Antibody Concentrations ≥ 0.20 μg/mL in the Unprimed Group
Hide Description 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.
Time Frame Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unprimed Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 60
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-6A at PRE Number Analyzed 60 participants
13
  21.7%
Anti-6A at Day 7 Number Analyzed 60 participants
24
  40.0%
Anti-6A at Month 3 Number Analyzed 60 participants
49
  81.7%
Anti-19A at PRE Number Analyzed 60 participants
22
  36.7%
Anti-19A at Day 7 Number Analyzed 59 participants
33
  55.9%
Anti-19A at Month 3 Number Analyzed 60 participants
58
  96.7%
19.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Synflorix™ Group 1 and Synflorix™ Group 2
Hide Description Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
Overall Number of Participants Analyzed 48 55
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Opsono-6A at Month 10 Number Analyzed 35 participants 44 participants
60.9
(25.9 to 143.1)
135
(68.3 to 267)
Opsono-6A at Month 34 Number Analyzed 40 participants 47 participants
64.3
(27.1 to 152.7)
81.5
(39.7 to 167.5)
Opsono-6A at Mth34+D7 Number Analyzed 45 participants 50 participants
1639.4
(958.6 to 2803.9)
1267.3
(713.8 to 2250)
Opsono-19A at Month 10 Number Analyzed 36 participants 46 participants
14.4
(7.6 to 27.3)
35.9
(18 to 71.6)
Opsono-19A at Month 34 Number Analyzed 45 participants 55 participants
8
(5.2 to 12.2)
8.6
(5.6 to 13.4)
Opsono-19A at Mth34+D7 Number Analyzed 48 participants 55 participants
799.3
(372.8 to 1713.4)
1871.6
(975.8 to 3589.8)
20.Secondary Outcome
Title Titers for Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes 6A and 19A in the Unprimed Group
Hide Description Seropositivity status defined as opsonophacocytic activity against pneumococcal serotypes ≥ 8.
Time Frame Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unprimed Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 58
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Opsono-6A at PRE Number Analyzed 50 participants
36.3
(18.9 to 69.6)
Opsono-6A at Day Number Analyzed 52 participants
389.6
(215.2 to 705.5)
Opsono-6A at Month Number Analyzed 52 participants
715.2
(487.3 to 1049.6)
Opsono-19A at PRE Number Analyzed 58 participants
5.4
(4.2 to 6.9)
Opsono-19A at Day 7 Number Analyzed 55 participants
211.9
(99.9 to 449.7)
Opsono-19A at Month 3 Number Analyzed 53 participants
406.4
(227.3 to 726.9)
21.Secondary Outcome
Title Concentrations of Antibodies Against Protein D (ANTI-PD) in the Synflorix™ Group 1 and Synflorix™ Group 2
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
Overall Number of Participants Analyzed 50 57
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PD at Month 10 Number Analyzed 48 participants 56 participants
1438
(1018.9 to 2029.4)
2241.3
(1752.5 to 2866.3)
Anti-PD at Month 34 Number Analyzed 50 participants 57 participants
301.6
(219.5 to 414.3)
461.3
(351.1 to 606)
Anti-PD at Mth34+D7 Number Analyzed 50 participants 55 participants
1724.1
(1299.4 to 2287.5)
2113.2
(1651.2 to 2704.5)
22.Secondary Outcome
Title Concentrations of Antibodies Against Protein D (ANTI-PD) in the Unprimed Group
Hide Description 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.
Time Frame Pre-vaccination (PRE/ Day 0), one week after dose 1 (Day 7) and one month after dose 2 (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unprimed Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 60
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PD at PRE
110.9
(88.8 to 138.6)
Anti-PD at Day 7
536.3
(390.7 to 736.2)
Anti-PD at Month 3
960.4
(752.7 to 1225.5)
23.Secondary Outcome
Title Number of Subjects With B-cells Detection in the Synflorix™ Group 1 and Synflorix™ Group 2
Hide Description 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.
Time Frame Pre-additional dose at Month 34 in the current study (Month 34) and one week after vaccination at Month 34+7 days (Mth34+D7)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
Overall Number of Participants Analyzed 10 13
Mean (Standard Deviation)
Unit of Measure: Participants
18C PS at Month 34 Number Analyzed 10 participants 11 participants
377  (459.3) 424.9  (668.2)
18C PS at Mth34+D7 Number Analyzed 7 participants 13 participants
1205.3  (661.4) 2891.2  (2274.5)
19F PS at Month 34 Number Analyzed 10 participants 11 participants
163.1  (306.4) 635.4  (1196.6)
19F PS at Mth34+D7 Number Analyzed 7 participants 13 participants
856.7  (1211.7) 1626  (1760.5)
23F PS at Month 34 Number Analyzed 10 participants 11 participants
174.2  (285) 212.2  (320.8)
23F PS at Mth34+D7 Number Analyzed 7 participants 13 participants
120.1  (92) 351.9  (400.4)
6B PS at Month 34 Number Analyzed 10 participants 11 participants
136.1  (131.8) 508.5  (606.3)
6B PS at Mth34+D7 Number Analyzed 7 participants 13 participants
153.1  (216) 469.7  (554.5)
C-PS at Month 34 Number Analyzed 10 participants 11 participants
246.3  (247.3) 751.2  (790.5)
C-PS at Mth34+D7 Number Analyzed 7 participants 13 participants
167.6  (92) 600.5  (488.8)
24.Secondary Outcome
Title Number of Subjects With B-cells Detection in the Unprimed Group
Hide Description 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.
Time Frame Pre-vaccination (PRE/ Day 0) and one week after dose 1 (Day 7)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Unprimed Group
Hide Arm/Group Description:
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 Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: Participants
18C PS at PRE Number Analyzed 12 participants
246.5  (310.8)
18C PS at Day 7 Number Analyzed 13 participants
3014.2  (4168.4)
19F PS at PRE Number Analyzed 12 participants
306.4  (423.1)
19F PS at Day 7 Number Analyzed 13 participants
599.8  (643.8)
23F PS at PRE Number Analyzed 12 participants
280  (492.2)
23F PS at Day 7 Number Analyzed 13 participants
450  (529.4)
6B PS at PRE Number Analyzed 12 participants
159.8  (220.7)
6B PS at Day 7 Number Analyzed 13 participants
432.4  (478.3)
C-PS at PRE Number Analyzed 12 participants
751.9  (463)
C-PS at Day 7 Number Analyzed 13 participants
789.2  (751.1)
25.Secondary Outcome
Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Hide Description 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).
Time Frame 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 Group
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2 Unprimed Group
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
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 Number of Participants Analyzed 51 59 62
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
41
  80.4%
44
  74.6%
49
  79.0%
Grade 3 Pain
3
   5.9%
4
   6.8%
6
   9.7%
Any Redness
34
  66.7%
35
  59.3%
41
  66.1%
Grade 3 Redness
9
  17.6%
12
  20.3%
15
  24.2%
Any Swelling
28
  54.9%
27
  45.8%
30
  48.4%
Grade 3 Swelling
5
   9.8%
9
  15.3%
9
  14.5%
26.Secondary Outcome
Title Number/ Percentage of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2 Unprimed Group
Hide Arm/Group Description:
Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
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 Number of Participants Analyzed 51 59 62
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness
20
  39.2%
23
  39.0%
17
  27.4%
Grade 3 Drowsiness
0
   0.0%
0
   0.0%
0
   0.0%
Related Drowsiness
20
  39.2%
23
  39.0%
17
  27.4%
Any Fever
9
  17.6%
5
   8.5%
8
  12.9%
Grade 3 Fever
0
   0.0%
0
   0.0%
0
   0.0%
Related Fever
9
  17.6%
4
   6.8%
7
  11.3%
Any Irr./Fuss.
20
  39.2%
27
  45.8%
21
  33.9%
Grade 3 Irr./Fuss.
0
   0.0%
0
   0.0%
0
   0.0%
Related Irr./Fuss.
20
  39.2%
25
  42.4%
20
  32.3%
Any Loss Appet.
12
  23.5%
13
  22.0%
14
  22.6%
Grade 3 Loss Appet.
0
   0.0%
0
   0.0%
0
   0.0%
Related Loss Appet.
12
  23.5%
13
  22.0%
14
  22.6%
27.Secondary Outcome
Title Number (%) of Subjects With Unsolicited Adverse Events
Hide Description 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.
Time Frame 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 Group
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2 Unprimed Group
Hide Arm/Group Description:
Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
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 Number of Participants Analyzed 51 59 62
Measure Type: Count of Participants
Unit of Measure: Participants
24
  47.1%
24
  40.7%
40
  64.5%
28.Secondary Outcome
Title Number (%) of Subjects With Serious Adverse Events
Hide Description 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.
Time Frame During the 31-day period following vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2 Unprimed Group
Hide Arm/Group Description:
Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.
Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age,
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 Number of Participants Analyzed 51 59 62
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.0%
1
   1.7%
1
   1.6%
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Synflorix™ Group 1 Synflorix™ Group 2 Unprimed Group
Hide Arm/Group Description Subjects previously vaccinated with the C™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age. Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age, 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.
All-Cause Mortality
Synflorix™ Group 1 Synflorix™ Group 2 Unprimed Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/51 (1.96%)   1/59 (1.69%)   1/62 (1.61%) 
Show Serious Adverse Events Hide Serious Adverse Events
Synflorix™ Group 1 Synflorix™ Group 2 Unprimed Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/51 (1.96%)   1/59 (1.69%)   1/62 (1.61%) 
Gastrointestinal disorders       
Gastritis  1  1/51 (1.96%)  0/59 (0.00%)  0/62 (0.00%) 
Infections and infestations       
Bronchitis  1  0/51 (0.00%)  0/59 (0.00%)  1/62 (1.61%) 
Pyelonephritis  1  0/51 (0.00%)  1/59 (1.69%)  0/62 (0.00%) 
1
Term from vocabulary, MedDRA 12.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Synflorix™ Group 1 Synflorix™ Group 2 Unprimed Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   41/51 (80.39%)   44/59 (74.58%)   49/62 (79.03%) 
Gastrointestinal disorders       
Vomiting  1  3/51 (5.88%)  3/59 (5.08%)  2/62 (3.23%) 
General disorders       
Pain  1  41/51 (80.39%)  44/59 (74.58%)  49/62 (79.03%) 
Pyrexia  1  7/51 (13.73%)  8/59 (13.56%)  7/62 (11.29%) 
Swelling  1  28/51 (54.90%)  27/59 (45.76%)  30/62 (48.39%) 
Redness  1  34/51 (66.67%)  35/59 (59.32%)  41/62 (66.13%) 
Drowsiness  1  20/51 (39.22%)  23/59 (38.98%)  17/62 (27.42%) 
Fever (Rectally, ≥ 38.0°C)  1  9/51 (17.65%)  5/59 (8.47%)  8/62 (12.90%) 
Loss of appetite  1  12/51 (23.53%)  13/59 (22.03%)  14/62 (22.58%) 
Infections and infestations       
Bronchitis  1  2/51 (3.92%)  3/59 (5.08%)  6/62 (9.68%) 
Nasopharyngitis  1  1/51 (1.96%)  4/59 (6.78%)  12/62 (19.35%) 
Upper respiratory tract infection  1  2/51 (3.92%)  3/59 (5.08%)  4/62 (6.45%) 
Viral infection  1  0/51 (0.00%)  1/59 (1.69%)  6/62 (9.68%) 
Psychiatric disorders       
Irritability  1  20/51 (39.22%)  27/59 (45.76%)  21/62 (33.87%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/51 (1.96%)  5/59 (8.47%)  5/62 (8.06%) 
1
Term from vocabulary, MedDRA 12.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Silfverdal SA et al. Assessment of immunological memory following PHiD-CV immunisation according to 2+1 or 3+1 schedules in the first year of life. Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Silfverdal SA et al. Immunogenicity/reactogenicity of 2-dose catch-up vaccination with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) during fourth year of life. Abstract presented at the 8th Biennial International Symposium on Pneumococci & Pneumococcal Diseases (ISPPD), Foz de Iguaçu, Brazil, 11-15 March 2012.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00792909     History of Changes
Other Study ID Numbers: 111736
First Submitted: November 17, 2008
First Posted: November 18, 2008
Results First Submitted: May 12, 2017
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017