Trial Outcomes & Findings for Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A (NCT NCT01175083)
NCT ID: NCT01175083
Last Updated: 2019-06-06
Results Overview
Antibodies have been assessed against the following 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), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (\<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
300 participants
Primary outcome timeframe
One month after primary vaccination (Month 3)
Results posted on
2019-06-06
Participant Flow
Participant milestones
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Primary Epoch
STARTED
|
50
|
50
|
50
|
50
|
50
|
50
|
|
Primary Epoch
COMPLETED
|
50
|
50
|
50
|
50
|
50
|
47
|
|
Primary Epoch
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
3
|
|
Booster Epoch
STARTED
|
49
|
49
|
50
|
50
|
0
|
0
|
|
Booster Epoch
COMPLETED
|
49
|
49
|
49
|
49
|
0
|
0
|
|
Booster Epoch
NOT COMPLETED
|
0
|
0
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Primary Epoch
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
2
|
|
Primary Epoch
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Booster Epoch
Death
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Booster Epoch
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Immunization of Children Between 8 Weeks and 2 Years of Age With GSK Pneumococcal Vaccine GSK1024850A
Baseline characteristics by cohort
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=50 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=50 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
n=50 Participants
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
n=50 Participants
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
n=50 Participants
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
n=50 Participants
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
8.4 Weeks
STANDARD_DEVIATION 0.9 • n=5 Participants
|
8.6 Weeks
STANDARD_DEVIATION 0.9 • n=7 Participants
|
8.6 Weeks
STANDARD_DEVIATION 1.5 • n=5 Participants
|
8.3 Weeks
STANDARD_DEVIATION 1.2 • n=4 Participants
|
16.6 Weeks
STANDARD_DEVIATION 3.3 • n=21 Participants
|
16.7 Weeks
STANDARD_DEVIATION 3.5 • n=8 Participants
|
11.2 Weeks
STANDARD_DEVIATION 4.4 • n=8 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
147 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
153 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
African Heritage/African American
|
50 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
50 Participants
n=8 Participants
|
300 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: One month after primary vaccination (Month 3)Population: The analysis was performed on the According To Protocol (ATP) immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at Month 3.
Antibodies have been assessed against the following 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), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration greater than or equal to (≥) 0.05 micrograms per milliliter (µg/mL). Antibody concentrations below than (\<) 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=48 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=46 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-1
|
3.51 µg/mL
Interval 2.77 to 4.44
|
3.63 µg/mL
Interval 2.91 to 4.53
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-9V
|
4.56 µg/mL
Interval 3.51 to 5.92
|
4.59 µg/mL
Interval 3.7 to 5.7
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-14
|
4.30 µg/mL
Interval 3.08 to 6.0
|
5.95 µg/mL
Interval 4.27 to 8.29
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-4
|
4.25 µg/mL
Interval 3.18 to 5.67
|
3.51 µg/mL
Interval 2.73 to 4.51
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-5
|
5.15 µg/mL
Interval 4.07 to 6.51
|
5.94 µg/mL
Interval 4.91 to 7.18
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-6B
|
1.29 µg/mL
Interval 0.83 to 1.99
|
1.13 µg/mL
Interval 0.74 to 1.72
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-7F
|
4.91 µg/mL
Interval 3.84 to 6.28
|
4.28 µg/mL
Interval 3.49 to 5.26
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-18C
|
14.60 µg/mL
Interval 11.01 to 19.36
|
11.33 µg/mL
Interval 8.47 to 15.17
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-19F
|
11.87 µg/mL
Interval 9.05 to 15.57
|
9.78 µg/mL
Interval 7.01 to 13.64
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-23F
|
1.32 µg/mL
Interval 0.9 to 1.93
|
1.41 µg/mL
Interval 0.95 to 2.11
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: One month after the primary vaccination (Month 3)Population: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at Month 3.
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=47 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=46 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
|
2789.09 EL.U/mL
Interval 2313.89 to 3361.87
|
3065.40 EL.U/mL
Interval 2530.54 to 3713.31
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to the primary vaccination (Month 0), prior to (Month 8) and one month after (Month 9) booster vaccinationPopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at the specified time point.
Antibodies have been assessed against the following 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), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=48 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=46 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-1, Month 0
|
0.09 μg/mL
Interval 0.06 to 0.12
|
0.09 μg/mL
Interval 0.06 to 0.12
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-4, Month 8
|
1.20 μg/mL
Interval 0.91 to 1.59
|
1.08 μg/mL
Interval 0.77 to 1.52
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-5, Month 8
|
1.13 μg/mL
Interval 0.87 to 1.47
|
1.23 μg/mL
Interval 0.93 to 1.63
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-5, Month 9
|
6.30 μg/mL
Interval 4.94 to 8.04
|
6.91 μg/mL
Interval 4.92 to 9.73
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-6B, Month 0
|
0.07 μg/mL
Interval 0.05 to 0.09
|
0.11 μg/mL
Interval 0.07 to 0.18
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-6B, Month 8
|
1.94 μg/mL
Interval 1.55 to 2.44
|
1.62 μg/mL
Interval 1.25 to 2.09
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-7F, Month 8
|
1.83 μg/mL
Interval 1.41 to 2.37
|
1.57 μg/mL
Interval 1.21 to 2.05
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-7F, Month 9
|
9.03 μg/mL
Interval 7.18 to 11.37
|
8.19 μg/mL
Interval 6.18 to 10.86
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-1, Month 8
|
0.67 μg/mL
Interval 0.54 to 0.84
|
0.69 μg/mL
Interval 0.52 to 0.9
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-1, Month 9
|
5.34 μg/mL
Interval 4.07 to 7.02
|
5.14 μg/mL
Interval 3.52 to 7.5
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-4, Month 0
|
0.04 μg/mL
Interval 0.03 to 0.06
|
0.06 μg/mL
Interval 0.04 to 0.08
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-4, Month 9
|
7.04 μg/mL
Interval 5.53 to 8.97
|
6.02 μg/mL
Interval 4.4 to 8.24
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-5, Month 0
|
0.06 μg/mL
Interval 0.05 to 0.09
|
0.07 μg/mL
Interval 0.06 to 0.1
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-9V, Month 0
|
0.12 μg/mL
Interval 0.08 to 0.16
|
0.12 μg/mL
Interval 0.09 to 0.16
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-9V, Month 8
|
1.61 μg/mL
Interval 1.17 to 2.21
|
1.44 μg/mL
Interval 1.13 to 1.82
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-6B, Month 9
|
5.07 μg/mL
Interval 4.16 to 6.18
|
5.00 μg/mL
Interval 3.71 to 6.74
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-7F, Month 0
|
0.08 μg/mL
Interval 0.06 to 0.11
|
0.13 μg/mL
Interval 0.09 to 0.19
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-9V, Month 9
|
8.19 μg/mL
Interval 6.61 to 10.14
|
7.95 μg/mL
Interval 5.94 to 10.63
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-14, Month 0
|
0.77 μg/mL
Interval 0.53 to 1.12
|
0.65 μg/mL
Interval 0.42 to 0.99
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-14, Month 8
|
2.58 μg/mL
Interval 1.9 to 3.51
|
2.10 μg/mL
Interval 1.32 to 3.34
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-14, Month 9
|
8.66 μg/mL
Interval 6.91 to 10.85
|
7.43 μg/mL
Interval 4.72 to 11.7
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-18C, Month 0
|
0.13 μg/mL
Interval 0.1 to 0.18
|
0.13 μg/mL
Interval 0.09 to 0.18
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-18C, Month 8
|
3.82 μg/mL
Interval 2.97 to 4.92
|
3.16 μg/mL
Interval 2.32 to 4.31
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-18C, Month 9
|
16.52 μg/mL
Interval 12.81 to 21.32
|
16.74 μg/mL
Interval 12.98 to 21.58
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-19F, Month 0
|
0.34 μg/mL
Interval 0.23 to 0.51
|
0.30 μg/mL
Interval 0.21 to 0.44
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-19F, Month 8
|
3.31 μg/mL
Interval 2.51 to 4.38
|
3.27 μg/mL
Interval 2.21 to 4.84
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-19F, Month 9
|
10.96 μg/mL
Interval 8.37 to 14.34
|
11.27 μg/mL
Interval 8.18 to 15.54
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-23F, Month 0
|
0.13 μg/mL
Interval 0.09 to 0.2
|
0.10 μg/mL
Interval 0.07 to 0.14
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-23F, Month 8
|
0.67 μg/mL
Interval 0.48 to 0.94
|
0.77 μg/mL
Interval 0.51 to 1.17
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-23F, Month 9
|
4.86 μg/mL
Interval 3.34 to 7.07
|
4.54 μg/mL
Interval 2.7 to 7.62
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccinationPopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at the specified time point.
Antibodies have been assessed against the following 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), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=50 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=50 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-6B, Month 3
|
1.51 µg/mL
Interval 1.06 to 2.15
|
1.35 µg/mL
Interval 0.98 to 1.87
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-6B, Month 4
|
3.12 µg/mL
Interval 2.1 to 4.64
|
2.93 µg/mL
Interval 2.17 to 3.95
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-7F, Month 2
|
8.51 µg/mL
Interval 6.94 to 10.42
|
6.67 µg/mL
Interval 5.44 to 8.19
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-7F, Month 3
|
5.46 µg/mL
Interval 4.37 to 6.83
|
4.68 µg/mL
Interval 3.76 to 5.81
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-14, Month 0
|
0.08 µg/mL
Interval 0.06 to 0.12
|
0.07 µg/mL
Interval 0.05 to 0.1
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-18C, Month 2
|
12.92 µg/mL
Interval 9.93 to 16.82
|
14.62 µg/mL
Interval 11.61 to 18.4
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-18C, Month 3
|
8.43 µg/mL
Interval 6.53 to 10.88
|
11.49 µg/mL
Interval 9.24 to 14.29
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-18C, Month 4
|
23.57 µg/mL
Interval 18.38 to 30.22
|
31.88 µg/mL
Interval 25.34 to 40.11
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-19F, Month 0
|
0.05 µg/mL
Interval 0.04 to 0.06
|
0.04 µg/mL
Interval 0.04 to 0.06
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-7F, Month 4
|
11.08 µg/mL
Interval 8.9 to 13.81
|
10.29 µg/mL
Interval 7.92 to 13.37
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-9V, Month 0
|
0.04 µg/mL
Interval 0.03 to 0.05
|
0.04 µg/mL
Interval 0.03 to 0.05
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-9V, Month 2
|
2.55 µg/mL
Interval 1.86 to 3.49
|
1.67 µg/mL
Interval 1.21 to 2.29
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-9V, Month 3
|
1.90 µg/mL
Interval 1.42 to 2.56
|
1.52 µg/mL
Interval 1.16 to 2.0
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-9V, Month 4
|
4.73 µg/mL
Interval 3.4 to 6.58
|
3.76 µg/mL
Interval 2.67 to 5.3
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-14, Month 2
|
4.91 µg/mL
Interval 3.48 to 6.95
|
4.81 µg/mL
Interval 3.67 to 6.29
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-14, Month 3
|
4.71 µg/mL
Interval 3.45 to 6.43
|
4.98 µg/mL
Interval 4.01 to 6.2
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-1, Month 0
|
0.03 µg/mL
Interval 0.03 to 0.03
|
0.04 µg/mL
Interval 0.03 to 0.05
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-1, Month 2
|
5.48 µg/mL
Interval 4.34 to 6.93
|
3.99 µg/mL
Interval 3.24 to 4.91
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-1, Month 3
|
2.68 µg/mL
Interval 2.12 to 3.39
|
2.44 µg/mL
Interval 1.99 to 2.98
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-1, Month 4
|
5.51 µg/mL
Interval 4.27 to 7.1
|
4.92 µg/mL
Interval 3.74 to 6.48
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-4, Month 0
|
0.03 µg/mL
Interval 0.03 to 0.04
|
0.03 µg/mL
Interval 0.02 to 0.04
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-4, Month 2
|
10.88 µg/mL
Interval 8.94 to 13.24
|
7.55 µg/mL
Interval 6.0 to 9.5
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-4, Month 3
|
5.72 µg/mL
Interval 4.66 to 7.03
|
4.32 µg/mL
Interval 3.51 to 5.32
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-4, Month 4
|
9.75 µg/mL
Interval 7.67 to 12.39
|
7.88 µg/mL
Interval 6.28 to 9.89
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-5, Month 0
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.06 µg/mL
Interval 0.05 to 0.08
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-5, Month 2
|
6.76 µg/mL
Interval 5.14 to 8.89
|
4.59 µg/mL
Interval 3.58 to 5.88
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-5, Month 3
|
3.68 µg/mL
Interval 2.87 to 4.73
|
3.40 µg/mL
Interval 2.66 to 4.33
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-5, Month 4
|
7.75 µg/mL
Interval 6.05 to 9.92
|
7.87 µg/mL
Interval 6.02 to 10.29
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-6B, Month 0
|
0.03 µg/mL
Interval 0.02 to 0.03
|
0.03 µg/mL
Interval 0.02 to 0.03
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-6B, Month 2
|
1.61 µg/mL
Interval 1.03 to 2.52
|
1.48 µg/mL
Interval 1.02 to 2.13
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-7F, Month 0
|
0.04 µg/mL
Interval 0.03 to 0.05
|
0.04 µg/mL
Interval 0.03 to 0.05
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-14, Month 4
|
10.24 µg/mL
Interval 7.96 to 13.18
|
10.69 µg/mL
Interval 8.34 to 13.71
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-18C, Month 0
|
0.03 µg/mL
Interval 0.03 to 0.03
|
0.03 µg/mL
Interval 0.03 to 0.04
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-19F, Month 2
|
11.13 µg/mL
Interval 7.97 to 15.54
|
9.77 µg/mL
Interval 6.16 to 15.48
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-23F, Month 0
|
0.03 µg/mL
Interval 0.03 to 0.04
|
0.04 µg/mL
Interval 0.03 to 0.05
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-23F, Month 2
|
1.29 µg/mL
Interval 0.79 to 2.1
|
0.93 µg/mL
Interval 0.6 to 1.45
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-23F, Month 3
|
1.00 µg/mL
Interval 0.65 to 1.56
|
1.08 µg/mL
Interval 0.74 to 1.56
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-23F, Month 4
|
3.11 µg/mL
Interval 1.85 to 5.24
|
3.17 µg/mL
Interval 2.04 to 4.91
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-19F, Month 3
|
6.54 µg/mL
Interval 4.79 to 8.92
|
7.39 µg/mL
Interval 5.04 to 10.81
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-19F, Month 4
|
15.59 µg/mL
Interval 11.24 to 21.62
|
15.85 µg/mL
Interval 10.52 to 23.89
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dosePopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one vaccine antigen component were available at the specified time point.
Antibodies have been assessed against the following 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), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=48 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=47 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-6B, Month 3
|
1.37 μg/mL
Interval 0.91 to 2.07
|
1.25 μg/mL
Interval 0.87 to 1.79
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-7F, Month 0
|
0.07 μg/mL
Interval 0.05 to 0.11
|
0.05 μg/mL
Interval 0.04 to 0.07
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-7F, Month 2
|
2.74 μg/mL
Interval 2.13 to 3.52
|
3.17 μg/mL
Interval 2.56 to 3.93
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-4, Month 0
|
0.04 μg/mL
Interval 0.03 to 0.05
|
0.04 μg/mL
Interval 0.03 to 0.05
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-1, Month 0
|
0.04 μg/mL
Interval 0.03 to 0.05
|
0.04 μg/mL
Interval 0.03 to 0.05
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-1, Month 2
|
1.39 μg/mL
Interval 1.07 to 1.8
|
1.49 μg/mL
Interval 1.18 to 1.89
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-1, Month 3
|
4.67 μg/mL
Interval 3.75 to 5.81
|
4.26 μg/mL
Interval 3.38 to 5.37
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-6B, Month 0
|
0.03 μg/mL
Interval 0.03 to 0.04
|
0.04 μg/mL
Interval 0.03 to 0.05
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-6B, Month 2
|
0.41 μg/mL
Interval 0.28 to 0.62
|
0.34 μg/mL
Interval 0.24 to 0.48
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-9V, Month 0
|
0.08 μg/mL
Interval 0.05 to 0.12
|
0.05 μg/mL
Interval 0.04 to 0.07
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-4, Month 2
|
4.22 μg/mL
Interval 3.23 to 5.51
|
3.74 μg/mL
Interval 2.96 to 4.72
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-4, Month 3
|
8.87 μg/mL
Interval 7.03 to 11.19
|
7.02 μg/mL
Interval 5.85 to 8.43
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-5, Month 0
|
0.06 μg/mL
Interval 0.05 to 0.08
|
0.08 μg/mL
Interval 0.06 to 0.11
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-5, Month 2
|
1.06 μg/mL
Interval 0.77 to 1.47
|
1.10 μg/mL
Interval 0.83 to 1.44
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-5, Month 3
|
5.52 μg/mL
Interval 4.23 to 7.2
|
4.07 μg/mL
Interval 3.06 to 5.42
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-9V, Month 2
|
0.99 μg/mL
Interval 0.72 to 1.34
|
0.83 μg/mL
Interval 0.62 to 1.11
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-7F, Month 3
|
6.81 μg/mL
Interval 5.32 to 8.7
|
6.36 μg/mL
Interval 5.25 to 7.69
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-9V, Month 3
|
2.35 μg/mL
Interval 1.85 to 3.0
|
1.72 μg/mL
Interval 1.31 to 2.25
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-14, Month 0
|
0.11 μg/mL
Interval 0.07 to 0.16
|
0.09 μg/mL
Interval 0.06 to 0.12
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-14, Month 2
|
1.87 μg/mL
Interval 1.46 to 2.4
|
1.24 μg/mL
Interval 0.92 to 1.66
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-14, Month 3
|
7.59 μg/mL
Interval 5.84 to 9.87
|
5.75 μg/mL
Interval 4.33 to 7.62
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-18C, Month 0
|
0.04 μg/mL
Interval 0.03 to 0.06
|
0.05 μg/mL
Interval 0.04 to 0.07
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-18C, Month 2
|
6.21 μg/mL
Interval 4.77 to 8.1
|
6.12 μg/mL
Interval 4.56 to 8.21
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-18C, Month 3
|
25.52 μg/mL
Interval 20.66 to 31.53
|
22.64 μg/mL
Interval 18.14 to 28.26
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-19F, Month 0
|
0.06 μg/mL
Interval 0.04 to 0.09
|
0.08 μg/mL
Interval 0.05 to 0.12
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-19F, Month 2
|
5.88 μg/mL
Interval 4.44 to 7.8
|
5.12 μg/mL
Interval 3.79 to 6.94
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-19F, Month 3
|
18.00 μg/mL
Interval 13.97 to 23.2
|
14.46 μg/mL
Interval 10.81 to 19.34
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-23F, Month 0
|
0.03 μg/mL
Interval 0.03 to 0.04
|
0.05 μg/mL
Interval 0.03 to 0.07
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-23F, Month 2
|
0.50 μg/mL
Interval 0.32 to 0.77
|
0.35 μg/mL
Interval 0.25 to 0.49
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-23F, Month 3
|
1.95 μg/mL
Interval 1.32 to 2.87
|
1.40 μg/mL
Interval 1.05 to 1.87
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccinationPopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.
Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=48 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=45 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-6A, Month 0
|
0.10 µg/mL
Interval 0.07 to 0.14
|
0.15 µg/mL
Interval 0.1 to 0.23
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-6A, Month 3
|
0.12 µg/mL
Interval 0.08 to 0.17
|
0.10 µg/mL
Interval 0.07 to 0.13
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-6A, Month 8
|
0.40 µg/mL
Interval 0.27 to 0.61
|
0.18 µg/mL
Interval 0.1 to 0.3
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-6A, Month 9
|
0.48 µg/mL
Interval 0.31 to 0.74
|
0.36 µg/mL
Interval 0.23 to 0.55
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-19A, Month 0
|
0.24 µg/mL
Interval 0.17 to 0.36
|
0.23 µg/mL
Interval 0.16 to 0.33
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-19A, Month 3
|
0.26 µg/mL
Interval 0.17 to 0.39
|
0.25 µg/mL
Interval 0.17 to 0.37
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-19A, Month 8
|
0.23 µg/mL
Interval 0.15 to 0.37
|
0.21 µg/mL
Interval 0.13 to 0.35
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-19A, Month 9
|
1.09 µg/mL
Interval 0.65 to 1.83
|
0.85 µg/mL
Interval 0.5 to 1.43
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccinationPopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.
Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=50 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=49 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-6A, Month 0
|
0.03 Titer
Interval 0.03 to 0.04
|
0.03 Titer
Interval 0.03 to 0.04
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-6A, Month 2
|
0.18 Titer
Interval 0.11 to 0.3
|
0.16 Titer
Interval 0.11 to 0.24
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-6A, Month 3
|
0.23 Titer
Interval 0.14 to 0.37
|
0.22 Titer
Interval 0.16 to 0.32
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-6A, Month 4
|
0.44 Titer
Interval 0.28 to 0.7
|
0.43 Titer
Interval 0.3 to 0.62
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-19A, Month 0
|
0.04 Titer
Interval 0.03 to 0.06
|
0.06 Titer
Interval 0.04 to 0.1
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-19A, Month 2
|
0.46 Titer
Interval 0.28 to 0.76
|
0.77 Titer
Interval 0.5 to 1.18
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-19A, Month 3
|
0.44 Titer
Interval 0.27 to 0.7
|
0.77 Titer
Interval 0.51 to 1.17
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-19A, Month 4
|
1.49 Titer
Interval 0.93 to 2.38
|
2.35 Titer
Interval 1.5 to 3.67
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dosePopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.
Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A (Anti-6A, -19A) were measured by 22F enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 micrograms per milliliter (µg/mL). Antibody concentrations \< 0.05 µg/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=48 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=47 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-6A, Month 0
|
0.03 Titer
Interval 0.03 to 0.03
|
0.04 Titer
Interval 0.03 to 0.05
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-6A, Month 2
|
0.15 Titer
Interval 0.1 to 0.23
|
0.12 Titer
Interval 0.08 to 0.18
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-6A, Month 3
|
0.39 Titer
Interval 0.23 to 0.66
|
0.31 Titer
Interval 0.2 to 0.48
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-19A, Month 0
|
0.06 Titer
Interval 0.04 to 0.09
|
0.07 Titer
Interval 0.04 to 0.11
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-19A, Month 2
|
0.77 Titer
Interval 0.5 to 1.17
|
0.75 Titer
Interval 0.47 to 1.19
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-19A, Month 3
|
3.15 Titer
Interval 2.13 to 4.65
|
2.79 Titer
Interval 1.93 to 4.05
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccinationPopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom data concerning immunogenicity outcomes and assay results for antibodies against protein D were available at the specified time point.
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=47 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=46 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentration of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-PD, Month 0
|
64.75 EL.U/mL
Interval 50.56 to 82.92
|
70.97 EL.U/mL
Interval 53.71 to 93.78
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-PD, Month 8
|
859.87 EL.U/mL
Interval 681.75 to 1084.52
|
840.88 EL.U/mL
Interval 641.5 to 1102.23
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Protein D (PD) for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
Anti-PD, Month 9
|
2871.72 EL.U/mL
Interval 2338.21 to 3526.96
|
3137.87 EL.U/mL
Interval 2459.92 to 4002.68
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccinationPopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against protein D were available at the specified time point.
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=50 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=50 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-PD, Month 0
|
72.73 EL.U/mL
Interval 57.23 to 92.42
|
88.74 EL.U/mL
Interval 70.85 to 111.13
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-PD, Month 2
|
1313.39 EL.U/mL
Interval 1014.3 to 1700.67
|
1489.78 EL.U/mL
Interval 1171.98 to 1893.76
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-PD, Month 3
|
932.52 EL.U/mL
Interval 732.63 to 1186.96
|
1063.54 EL.U/mL
Interval 844.52 to 1339.37
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
Anti-PD, Month 4
|
2695.50 EL.U/mL
Interval 2150.74 to 3378.24
|
2638.27 EL.U/mL
Interval 2049.91 to 3395.49
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dosePopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and assay results for antibodies against protein D were available at the specified time point.
Anti-PD antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL. Antibody concentrations \< 100 EL.U/mL were given an arbitrary value of half the cut-off for the purpose of GMC calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=48 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=47 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-PD, Month 0
|
79.59 EL.U/mL
Interval 62.08 to 102.04
|
76.22 EL.U/mL
Interval 61.39 to 94.63
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-PD, Month 2
|
199.23 EL.U/mL
Interval 150.51 to 263.72
|
184.34 EL.U/mL
Interval 140.21 to 242.35
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Protein D (PD) for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
Anti-PD, Month 3
|
1376.56 EL.U/mL
Interval 1020.71 to 1856.46
|
760.99 EL.U/mL
Interval 553.23 to 1046.77
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccinationPopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom opsonophagocytic activity assay results for antibodies against at least one vaccine antigen component were available at the specified time point.
Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=46 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=41 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-1, Month 3
|
106.4 Titer
Interval 56.0 to 202.2
|
94.6 Titer
Interval 49.9 to 179.5
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-1, Month 8
|
11.7 Titer
Interval 6.8 to 20.1
|
10.9 Titer
Interval 6.0 to 20.1
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-1, Month 9
|
930.5 Titer
Interval 606.3 to 1427.9
|
750.4 Titer
Interval 401.4 to 1403.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-4, Month 3
|
1316.6 Titer
Interval 1014.0 to 1709.7
|
992.5 Titer
Interval 680.0 to 1448.4
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-4, Month 8
|
222.1 Titer
Interval 130.6 to 377.8
|
108.3 Titer
Interval 51.6 to 227.6
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-4, Month 9
|
2064.2 Titer
Interval 1625.3 to 2621.8
|
2079.3 Titer
Interval 1425.7 to 3032.7
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-5, Month 3
|
106.9 Titer
Interval 66.8 to 171.2
|
119.4 Titer
Interval 81.4 to 175.2
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-5, Month 8
|
14.9 Titer
Interval 8.9 to 24.9
|
15.8 Titer
Interval 9.6 to 26.1
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-5, Month 9
|
273.2 Titer
Interval 200.6 to 372.0
|
277.5 Titer
Interval 168.8 to 456.1
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-6B, Month 3
|
1043.3 Titer
Interval 605.3 to 1798.3
|
446.2 Titer
Interval 207.4 to 960.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-6B, Month 8
|
285.3 Titer
Interval 150.1 to 542.1
|
245.6 Titer
Interval 115.0 to 524.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-6B, Month 9
|
952.2 Titer
Interval 638.8 to 1419.3
|
989.2 Titer
Interval 530.6 to 1843.9
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-7F, Month 3
|
4644.1 Titer
Interval 3519.3 to 6128.4
|
4924.2 Titer
Interval 3430.2 to 7068.8
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-7F, Month 8
|
1747.2 Titer
Interval 1225.4 to 2491.3
|
1585.7 Titer
Interval 1133.8 to 2217.8
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-7F, Month 9
|
7262.9 Titer
Interval 5257.6 to 10033.1
|
8120.3 Titer
Interval 5802.1 to 11364.8
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-9V, Month 3
|
1438.6 Titer
Interval 1084.0 to 1909.3
|
1116.8 Titer
Interval 679.6 to 1835.2
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-9V, Month 8
|
215.5 Titer
Interval 97.5 to 476.1
|
244.5 Titer
Interval 123.9 to 482.2
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-9V, Month 9
|
2062.3 Titer
Interval 1569.0 to 2710.8
|
2987.2 Titer
Interval 2149.4 to 4151.6
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-14, Month 3
|
1689.9 Titer
Interval 1090.7 to 2618.2
|
1062.3 Titer
Interval 562.8 to 2005.2
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-14, Month 8
|
215.9 Titer
Interval 113.6 to 410.1
|
132.5 Titer
Interval 60.3 to 291.5
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-14, Month 9
|
1571.5 Titer
Interval 1114.2 to 2216.4
|
1454.1 Titer
Interval 741.8 to 2850.5
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-18C, Month 3
|
873.8 Titer
Interval 591.7 to 1290.4
|
524.7 Titer
Interval 319.6 to 861.6
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-18C, Month 8
|
46.5 Titer
Interval 28.5 to 75.7
|
28.7 Titer
Interval 17.5 to 47.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-18C, Month 9
|
1246.0 Titer
Interval 776.7 to 1999.0
|
1011.8 Titer
Interval 686.4 to 1491.4
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-19F, Month 3
|
558.9 Titer
Interval 376.3 to 830.2
|
266.1 Titer
Interval 148.2 to 477.8
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-19F, Month 8
|
60.7 Titer
Interval 37.1 to 99.3
|
43.4 Titer
Interval 22.6 to 83.2
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-19F, Month 9
|
652.9 Titer
Interval 413.3 to 1031.5
|
486.7 Titer
Interval 278.9 to 849.4
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-23F, Month 3
|
705.1 Titer
Interval 309.2 to 1607.8
|
759.7 Titer
Interval 326.7 to 1766.6
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-23F, Month 8
|
85.2 Titer
Interval 27.5 to 264.4
|
41.6 Titer
Interval 14.6 to 118.9
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-23F, Month 9
|
4231.2 Titer
Interval 2793.7 to 6408.3
|
1454.0 Titer
Interval 736.1 to 2872.3
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccinationPopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom opsonophagocytic activity assay results for antibodies against at least one vaccine antigen component were available at the specified time point.
Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=49 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=47 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-1, Month 0
|
4.9 Titer
Interval 3.8 to 6.3
|
4.5 Titer
Interval 3.6 to 5.7
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-1, Month 2
|
134.7 Titer
Interval 83.6 to 216.9
|
88.1 Titer
Interval 53.7 to 144.6
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-1, Month 3
|
74.2 Titer
Interval 42.6 to 129.3
|
48.0 Titer
Interval 26.6 to 86.7
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-1, Month 4
|
516.0 Titer
Interval 307.6 to 865.7
|
511.3 Titer
Interval 293.2 to 891.8
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-4, Month 0
|
5.1 Titer
Interval 3.6 to 7.2
|
11.8 Titer
Interval 5.7 to 24.5
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-4, Month 2
|
1636.3 Titer
Interval 1217.5 to 2199.2
|
1771.1 Titer
Interval 1359.0 to 2308.2
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-4, Month 3
|
812.7 Titer
Interval 584.5 to 1130.1
|
1048.3 Titer
Interval 790.4 to 1390.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-4, Month 4
|
2130.5 Titer
Interval 1639.1 to 2769.2
|
2415.5 Titer
Interval 1686.5 to 3459.8
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-5, Month 0
|
4.4 Titer
Interval 3.8 to 5.1
|
4.0 Titer
Interval 4.0 to 4.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-5, Month 2
|
105.7 Titer
Interval 67.7 to 165.1
|
85.8 Titer
Interval 59.4 to 124.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-5, Month 3
|
54.1 Titer
Interval 34.9 to 83.6
|
49.2 Titer
Interval 31.7 to 76.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-5, Month 4
|
277.4 Titer
Interval 180.7 to 425.7
|
289.6 Titer
Interval 190.9 to 439.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-6B, Month 0
|
7.9 Titer
Interval 4.6 to 13.8
|
8.5 Titer
Interval 4.7 to 15.4
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-6B, Month 2
|
702.5 Titer
Interval 413.2 to 1194.2
|
696.6 Titer
Interval 388.5 to 1249.2
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-6B, Month 3
|
708.3 Titer
Interval 422.9 to 1186.1
|
615.5 Titer
Interval 337.3 to 1123.1
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-6B, Month 4
|
1360.0 Titer
Interval 860.2 to 2150.3
|
1305.4 Titer
Interval 731.9 to 2328.4
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-7F, Month 0
|
215.3 Titer
Interval 91.2 to 508.1
|
643.5 Titer
Interval 293.4 to 1411.7
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-7F, Month 2
|
6694.3 Titer
Interval 5055.1 to 8864.9
|
10452.0 Titer
Interval 7782.7 to 14036.6
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-7F, Month 3
|
7776.9 Titer
Interval 6000.8 to 10078.7
|
9336.3 Titer
Interval 6752.4 to 12908.9
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-7F, Month 4
|
10854.8 Titer
Interval 9051.6 to 13017.2
|
9362.8 Titer
Interval 6882.3 to 12737.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-9V, Month 0
|
16.9 Titer
Interval 8.3 to 34.5
|
20.3 Titer
Interval 9.2 to 44.5
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-9V, Month 2
|
2858.2 Titer
Interval 1875.3 to 4356.2
|
2667.9 Titer
Interval 1677.9 to 4242.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-9V, Month 3
|
1982.9 Titer
Interval 1192.1 to 3298.2
|
1986.2 Titer
Interval 1167.8 to 3378.2
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-9V, Month 4
|
3047.9 Titer
Interval 2389.7 to 3887.3
|
2719.2 Titer
Interval 1681.0 to 4398.9
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-14, Month 0
|
5.5 Titer
Interval 3.8 to 8.1
|
5.9 Titer
Interval 3.8 to 9.1
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-14, Month 2
|
2109.5 Titer
Interval 1299.0 to 3425.9
|
4009.9 Titer
Interval 2501.9 to 6426.7
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-14, Month 3
|
1431.6 Titer
Interval 865.2 to 2368.6
|
2128.3 Titer
Interval 1477.5 to 3065.9
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-14, Month 4
|
3414.9 Titer
Interval 2237.4 to 5211.9
|
3717.3 Titer
Interval 2403.9 to 5748.5
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-18C, Month 0
|
4.1 Titer
Interval 3.9 to 4.5
|
4.6 Titer
Interval 3.4 to 6.2
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-18C, Month 2
|
744.4 Titer
Interval 393.3 to 1409.2
|
1605.6 Titer
Interval 937.1 to 2751.1
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-18C, Month 3
|
411.4 Titer
Interval 214.4 to 789.7
|
746.4 Titer
Interval 430.5 to 1294.1
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-18C, Month 4
|
2218.9 Titer
Interval 1577.5 to 3121.2
|
3238.7 Titer
Interval 1874.7 to 5595.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-19F, Month 0
|
4.2 Titer
Interval 3.8 to 4.7
|
4.0 Titer
Interval 4.0 to 4.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-19F, Month 2
|
393.4 Titer
Interval 214.4 to 722.0
|
491.5 Titer
Interval 256.8 to 940.6
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-19F, Month 3
|
160.2 Titer
Interval 86.8 to 295.6
|
279.5 Titer
Interval 161.1 to 484.9
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-19F, Month 4
|
1347.7 Titer
Interval 813.6 to 2232.3
|
1174.4 Titer
Interval 605.6 to 2277.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-23F, Month 0
|
7.6 Titer
Interval 4.1 to 13.9
|
15.3 Titer
Interval 6.4 to 36.6
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-23F, Month 2
|
1545.1 Titer
Interval 788.3 to 3028.2
|
2107.5 Titer
Interval 1155.0 to 3845.5
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-23F, Month 3
|
1168.8 Titer
Interval 560.8 to 2435.8
|
1026.2 Titer
Interval 458.3 to 2298.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-23F, Month 4
|
2038.8 Titer
Interval 977.1 to 4254.4
|
3525.1 Titer
Interval 1974.2 to 6294.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dosePopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom data concerning immunogenicity outcomes and opsonophagocytic activity assay results for antibodies against at least one vaccine antigen component were available at the specified time point.
Opsonophagocytic activity has been assessed against vaccine pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (OPA-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=47 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=45 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-1, Month 0
|
6.9 Titer
Interval 4.5 to 10.8
|
5.6 Titer
Interval 4.2 to 7.6
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-1, Month 2
|
9.3 Titer
Interval 6.1 to 14.3
|
10.9 Titer
Interval 6.8 to 17.4
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-1, Month 3
|
195.7 Titer
Interval 119.9 to 319.3
|
115.1 Titer
Interval 64.0 to 206.8
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-4, Month 0
|
8.0 Titer
Interval 4.7 to 13.6
|
7.3 Titer
Interval 4.3 to 12.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-4, Month 2
|
1086.3 Titer
Interval 758.4 to 1555.9
|
1539.4 Titer
Interval 1128.4 to 2100.1
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-4, Month 3
|
2089.7 Titer
Interval 1635.0 to 2670.8
|
3193.9 Titer
Interval 2241.3 to 4551.4
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-5, Month 0
|
5.5 Titer
Interval 4.2 to 7.4
|
4.4 Titer
Interval 3.6 to 5.4
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-5, Month 2
|
9.8 Titer
Interval 7.1 to 13.7
|
9.6 Titer
Interval 6.6 to 13.7
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-5, Month 3
|
151.3 Titer
Interval 99.8 to 229.2
|
84.0 Titer
Interval 53.5 to 131.8
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-6B, Month 0
|
13.6 Titer
Interval 6.7 to 27.6
|
9.9 Titer
Interval 5.2 to 18.7
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-6B, Month 2
|
345.1 Titer
Interval 172.4 to 690.7
|
278.4 Titer
Interval 131.8 to 588.4
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-6B, Month 3
|
748.4 Titer
Interval 425.9 to 1315.0
|
866.4 Titer
Interval 511.8 to 1466.7
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-7F, Month 0
|
1436.6 Titer
Interval 1014.4 to 2034.6
|
1228.1 Titer
Interval 783.3 to 1925.5
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-7F, Month 2
|
5462.3 Titer
Interval 4108.9 to 7261.4
|
5802.2 Titer
Interval 4678.6 to 7195.6
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-7F, Month 3
|
10279.4 Titer
Interval 7836.7 to 13483.6
|
10131.4 Titer
Interval 8303.7 to 12361.6
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-9V, Month 0
|
119.5 Titer
Interval 50.4 to 283.2
|
81.3 Titer
Interval 35.7 to 185.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-9V, Month 2
|
1976.2 Titer
Interval 1392.6 to 2804.4
|
2359.0 Titer
Interval 1514.3 to 3674.9
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-9V, Month 3
|
3778.2 Titer
Interval 2880.0 to 4956.4
|
4276.8 Titer
Interval 3122.3 to 5858.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-14, Month 0
|
16.3 Titer
Interval 8.3 to 31.8
|
12.0 Titer
Interval 5.3 to 27.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-14, Month 2
|
711.2 Titer
Interval 400.7 to 1262.4
|
865.6 Titer
Interval 583.2 to 1284.9
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-14, Month 3
|
2704.5 Titer
Interval 1856.4 to 3940.0
|
2737.5 Titer
Interval 1890.0 to 3965.1
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-18C, Month 0
|
4.9 Titer
Interval 4.0 to 6.0
|
4.0 Titer
Interval 4.0 to 4.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-18C, Month 2
|
1035.5 Titer
Interval 507.6 to 2112.5
|
449.2 Titer
Interval 222.8 to 905.9
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-18C, Month 3
|
2873.1 Titer
Interval 2070.0 to 3987.6
|
2126.8 Titer
Interval 1509.7 to 2996.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-19F, Month 0
|
5.5 Titer
Interval 4.2 to 7.3
|
4.0 Titer
Interval 4.0 to 4.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-19F, Month 2
|
229.1 Titer
Interval 132.9 to 395.0
|
248.0 Titer
Interval 143.0 to 430.1
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-19F, Month 3
|
1845.3 Titer
Interval 1169.3 to 2912.1
|
1271.4 Titer
Interval 825.4 to 1958.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-23F, Month 0
|
68.1 Titer
Interval 21.1 to 219.6
|
37.6 Titer
Interval 12.3 to 114.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-23F, Month 2
|
2572.2 Titer
Interval 1264.1 to 5233.9
|
2433.6 Titer
Interval 1309.7 to 4522.0
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Vaccine Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-23F, Month 3
|
5016.6 Titer
Interval 3176.6 to 7922.4
|
5325.4 Titer
Interval 2857.8 to 9923.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccinationPopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Synflorix with Tritanrix-HepB/Hib and Polio Sabin vaccines, for whom opsonophagocytic activity assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.
Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=42 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=41 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-6A, Month 3
|
24.73 Titer
Interval 11.46 to 53.37
|
9.45 Titer
Interval 5.32 to 16.75
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-6A, Month 8
|
18.23 Titer
Interval 8.97 to 37.09
|
17.59 Titer
Interval 8.08 to 38.3
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-6A, Month 9
|
35.35 Titer
Interval 15.6 to 80.12
|
30.70 Titer
Interval 12.14 to 77.64
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-19A, Month 3
|
9.42 Titer
Interval 5.65 to 15.7
|
5.04 Titer
Interval 3.83 to 6.63
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-19A, Month 8
|
6.31 Titer
Interval 4.28 to 9.32
|
5.83 Titer
Interval 3.95 to 8.61
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Receiving Synflorix Vaccine Co-administered With Tritanrix-HepB/Hib and Polio Sabin Vaccines
OPA-19A, Month 9
|
22.06 Titer
Interval 9.49 to 51.3
|
19.44 Titer
Interval 10.25 to 36.86
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) and one month after (Month 2) primary vaccination, prior to (Month 3) and one month after (Month 4) booster vaccinationPopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose primary vaccination followed by a booster dose, for whom opsonophagocytic activity assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.
Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=49 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=45 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-6A, Month 0
|
4.81 Titer
Interval 3.71 to 6.24
|
5.02 Titer
Interval 3.64 to 6.9
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-6A, Month 2
|
40.59 Titer
Interval 19.11 to 86.23
|
51.23 Titer
Interval 22.85 to 114.88
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-6A, Month 3
|
38.11 Titer
Interval 17.04 to 85.21
|
36.27 Titer
Interval 16.89 to 77.89
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-6A, Month 4
|
77.09 Titer
Interval 35.58 to 167.04
|
98.18 Titer
Interval 43.05 to 223.96
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-19A, Month 0
|
4.49 Titer
Interval 3.91 to 5.16
|
4.33 Titer
Interval 3.68 to 5.1
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-19A, Month 2
|
15.21 Titer
Interval 7.95 to 29.08
|
108.31 Titer
Interval 49.55 to 236.78
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-19A, Month 3
|
14.65 Titer
Interval 7.71 to 27.81
|
19.40 Titer
Interval 8.04 to 46.82
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Followed by a Booster Dose
OPA-19A, Month 4
|
76.09 Titer
Interval 30.5 to 189.83
|
449.06 Titer
Interval 170.05 to 1185.87
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) the first vaccine dose, prior to (Month 2) and one month after (Month 3) the second vaccine dosePopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who received a two-dose vaccination without any booster dose, for whom opsonophagocytic activity assay results for antibodies against at least one cross-reactive pneumococcal serotype were available for the specified time point.
Opsonophagocytic activity has been assessed for cross-reactive vaccine pneumococcal serotypes 6A and 19A (OPA-6A, OPA-19A) and presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. Antibody titers \< 8 were given an arbitrary value of half the cut-off for the purpose of GMT calculation.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=44 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=42 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-6A, Month 0
|
9.26 Titer
Interval 5.76 to 14.89
|
6.35 Titer
Interval 4.02 to 10.02
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-6A, Month 2
|
82.82 Titer
Interval 40.27 to 170.33
|
77.25 Titer
Interval 31.81 to 187.64
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-6A, Month 3
|
147.91 Titer
Interval 63.11 to 346.68
|
157.37 Titer
Interval 59.23 to 418.11
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-19A, Month 0
|
5.85 Titer
Interval 4.27 to 8.01
|
6.32 Titer
Interval 4.09 to 9.76
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-19A, Month 2
|
28.37 Titer
Interval 11.84 to 67.98
|
25.68 Titer
Interval 11.6 to 56.84
|
—
|
—
|
—
|
—
|
|
Opsonophagocytic Titers Against Cross-reactive Pneumococcal Serotypes for Subjects Who Received a Two-dose Primary Vaccination Without Any Booster Dose
OPA-19A, Month 3
|
214.17 Titer
Interval 75.58 to 606.93
|
321.14 Titer
Interval 144.75 to 712.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccinationPopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Tritanrix-HepB/Hib vaccine, for whom data concerning immunogenicity outcomes and assay results for antibodies against diphtheria and tetanus toxoids were available at the specified time point.
Anti-DT and anti-TT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). Seroprotection status was defined as anti-DT or anti-TT antibody concentration ≥ than 0.1 IU/mL.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=48 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=46 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-DT, Month 0
|
0.07 IU/mL
Interval 0.05 to 0.08
|
0.06 IU/mL
Interval 0.05 to 0.07
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-DT, Month 3
|
3.22 IU/mL
Interval 2.59 to 4.0
|
3.50 IU/mL
Interval 2.82 to 4.34
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-DT, Month 8
|
0.62 IU/mL
Interval 0.5 to 0.77
|
0.90 IU/mL
Interval 0.72 to 1.12
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-DT, Month 9
|
6.58 IU/mL
Interval 5.44 to 7.97
|
7.55 IU/mL
Interval 6.11 to 9.32
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-TT, Month 0
|
1.54 IU/mL
Interval 1.13 to 2.09
|
1.22 IU/mL
Interval 0.85 to 1.76
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-TT, Month 3
|
4.04 IU/mL
Interval 3.26 to 5.01
|
4.13 IU/mL
Interval 3.27 to 5.22
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-TT, Month 8
|
1.19 IU/mL
Interval 0.96 to 1.48
|
1.33 IU/mL
Interval 1.08 to 1.63
|
—
|
—
|
—
|
—
|
|
Concentration of Antibodies Against Diphtheria Toxoid (DT) and Tetanus Toxoid (TT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-TT, Month 9
|
10.88 IU/mL
Interval 9.24 to 12.81
|
11.11 IU/mL
Interval 9.62 to 12.83
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Prior to (Month 0) and one month after (Month 3) primary vaccination, prior to (Month 8) and one month after (Month 9) booster vaccinationPopulation: The analysis was performed on the ATP immunogenicity cohort and included all subjects who were co-administered Tritanrix-HepB/Hib vaccine, for whom data concerning immunogenicity outcomes and assay results for antibodies against Bordetella pertussis were available at the specified time point.
Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 15 EL.U/mL.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=48 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=46 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Concentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-BPT, Month 0
|
7.71 EL.U/mL
Interval 7.29 to 8.16
|
7.77 EL.U/mL
Interval 7.39 to 8.17
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-BPT, Month 3
|
105.61 EL.U/mL
Interval 86.93 to 128.3
|
101.74 EL.U/mL
Interval 84.56 to 122.42
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-BPT, Month 8
|
22.67 EL.U/mL
Interval 17.45 to 29.45
|
22.69 EL.U/mL
Interval 17.88 to 28.8
|
—
|
—
|
—
|
—
|
|
Concentrations of Antibodies Against Bordetella Pertussis (BPT) for Subjects Who Were Co-administered Tritanrix-HepB/Hib Vaccine
Anti-BPT, Month 9
|
177.87 EL.U/mL
Interval 152.1 to 207.99
|
190.58 EL.U/mL
Interval 167.67 to 216.63
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-primary vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort for the primary epoch, which included all vaccinated subjects who completed their symptoms sheet for the respective dose. Note that dose 3 rows are not applicable for subjects from the 7-11 and 12-23 months of age groups as they only received a 2-dose primary vaccination.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=50 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=50 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
n=50 Participants
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
n=50 Participants
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
n=50 Participants
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
n=50 Participants
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Any Pain, Dose 1
|
8 Participants
|
12 Participants
|
7 Participants
|
10 Participants
|
9 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Grade 3 Pain, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Any Redness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Any Swelling, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Any Pain, Dose 2
|
7 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Grade 3 Pain, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Any Redness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Grade 3 Redness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Any Swelling, Dose 2
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Any Pain, Dose 3
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Grade 3 Pain, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Any Redness, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Grade 3 Redness, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Any Swelling, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Grade 3 Swelling, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Any Pain, Across doses
|
17 Participants
|
23 Participants
|
12 Participants
|
15 Participants
|
13 Participants
|
9 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Grade 3 Pain, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Any Redness, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Grade 3 Redness, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Any Swelling, Across doses
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Primary Vaccination Phase
Grade 3 Swelling, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-booster vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort for the booster epoch, which included all booster vaccinated subjects who completed their symptoms sheet. Note that no data are reported for the 12-23 months of age groups as they were not administered any vaccine during the booster phase.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=49 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=49 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
n=50 Participants
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
n=50 Participants
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase
Any Pain
|
11 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase
Grade 3 Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase
Any Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase
Grade 3 Redness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase
Any Swelling
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms During the Booster Vaccination Phase
Grade 3 Swelling
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-primary vaccination period following each dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort for the primary epoch, which included all vaccinated subjects who completed their symptoms sheet for the respective dose. Note that dose 3 rows are not applicable for subjects from the 7-11 and 12-23 months of age groups as they only received a 2-dose primary vaccination.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=50 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=50 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
n=50 Participants
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
n=50 Participants
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
n=50 Participants
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
n=50 Participants
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Fever, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Fever, Dose 1
|
31 Participants
|
29 Participants
|
19 Participants
|
22 Participants
|
21 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Drowsiness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Drowsiness, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Irritability, Across doses
|
3 Participants
|
6 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Irritability, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Irritability, Across doses
|
3 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Loss of appetite, Across doses
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Loss of appetite, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Loss of appetite, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Fever, Across doses
|
48 Participants
|
43 Participants
|
31 Participants
|
29 Participants
|
29 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Fever, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Fever, Across doses
|
46 Participants
|
43 Participants
|
29 Participants
|
25 Participants
|
28 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Drowsiness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Drowsiness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Drowsiness, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Irritability, Dose 1
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Irritability, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Irritability, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Loss of appetite, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Loss of appetite, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Loss of appetite, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Fever, Dose 1
|
34 Participants
|
31 Participants
|
22 Participants
|
26 Participants
|
21 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Drowsiness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Drowsiness, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Irritability, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Irritability, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Irritability, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Loss of appetite, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Loss of appetite, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Loss of appetite, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Fever, Dose 2
|
40 Participants
|
30 Participants
|
22 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Fever, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Fever, Dose 2
|
38 Participants
|
28 Participants
|
20 Participants
|
9 Participants
|
10 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Drowsiness, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Drowsiness, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Drowsiness, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Irritability, Dose 3
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Irritability, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Irritability, Dose 3
|
3 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Loss of appetite, Dose 3
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Loss of appetite, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Loss of appetite, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Fever, Dose 3
|
30 Participants
|
30 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Fever, Dose 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Related Fever, Dose 3
|
26 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Any Drowsiness, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Primary Vaccination Phase
Grade 3 Drowsiness, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-booster vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort for the booster epoch, which included all booster vaccinated subjects who completed their symptoms sheet. Note that no data are reported for the 12-23 months of age groups as they were not administered any vaccine during the booster phase.
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 40.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=49 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=49 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
n=50 Participants
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
n=50 Participants
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Any Drowsiness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Grade 3 Drowsiness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Related Drowsiness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Any Irritability
|
6 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Grade 3 Irritability
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Related Irritability
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Any Loss of appetite
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Grade 3 Loss of appetite
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Related Loss of appetite
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Any Fever
|
38 Participants
|
31 Participants
|
14 Participants
|
13 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Grade 3 Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms During the Booster Vaccination Phase
Related Fever
|
35 Participants
|
28 Participants
|
13 Participants
|
13 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) post-primary and post-booster vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort for the primary and booster epochs, which included all vaccinated subjects who received at least one dose of primary vaccination and the booster dose of study vaccine, respectively. Note that subjects from the 12-23 months of age groups did not participate in the Booster Epoch.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=50 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=50 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
n=50 Participants
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
n=50 Participants
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
n=50 Participants
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
n=50 Participants
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Any AE(s), post-primary vaccination
|
37 Participants
|
34 Participants
|
32 Participants
|
37 Participants
|
23 Participants
|
25 Participants
|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Any AE(s), post-booster vaccination
|
8 Participants
|
17 Participants
|
18 Participants
|
12 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: During the entire study period from Month 0 to Month 9Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects who received at least one dose of vaccination.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=50 Participants
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=50 Participants
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
n=50 Participants
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
n=50 Participants
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
n=50 Participants
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
n=50 Participants
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
3 Participants
|
9 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
Adverse Events
Tritanrix-HepB/Hib+Polio Sabin <6S Group
Serious events: 3 serious events
Other events: 50 other events
Deaths: 1 deaths
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
Serious events: 9 serious events
Other events: 49 other events
Deaths: 1 deaths
Synflorix 7-11S Group
Serious events: 3 serious events
Other events: 47 other events
Deaths: 1 deaths
Synflorix 7-11NS Group
Serious events: 4 serious events
Other events: 47 other events
Deaths: 0 deaths
Synflorix 12-23S Group
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
Synflorix 12-23NS Group
Serious events: 2 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=50 participants at risk
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=50 participants at risk
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
n=50 participants at risk
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
n=50 participants at risk
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
n=50 participants at risk
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
n=50 participants at risk
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
General disorders
Pyrexia
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
12.0%
6/50 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
4.0%
2/50 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Malaria
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
4.0%
2/50 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Meningitis salmonella
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Osteomyelitis acute
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Sepsis
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
Other adverse events
| Measure |
Tritanrix-HepB/Hib+Polio Sabin <6S Group
n=50 participants at risk
Children below (\<) 6 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Tritanrix-HepB/Hib+Polio Sabin <6NS Group
n=50 participants at risk
Healthy children, below (\<) 6 months of age at time of enrolment, who received a 3-dose primary vaccination at Study Months 0, 1 and 2 with Synflorix vaccine co-administered with Tritanrix-HepB/Hib and Polio Sabin vaccines, followed by a booster vaccination at Study Month 8.
|
Synflorix 7-11S Group
n=50 participants at risk
Children between 7-11 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 7-11NS Group
n=50 participants at risk
Healthy children between 7-11 months of age at time of enrolment, who received a 2-dose primary vaccination at Study Months 0 and 1 with Synflorix vaccine, followed by a booster vaccination at Study Month 3.
|
Synflorix 12-23S Group
n=50 participants at risk
Children between 12-23 months of age at time of enrolment, diagnosed with sickle cell disease (S), who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
Synflorix 12-23NS Group
n=50 participants at risk
Healthy children between 12-23 months of age at time of enrolment, who received a 2-dose vaccination with Synflorix vaccine, at Study Months 0 and 2.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
4.0%
2/50 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Bronchitis
|
18.0%
9/50 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
20.0%
10/50 • Number of events 12 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
12.0%
6/50 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
18.0%
9/50 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Eye disorders
Conjunctivitis
|
4.0%
2/50 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
4.0%
2/50 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
10.0%
5/50 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
4.0%
2/50 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.0%
8/50 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
12.0%
6/50 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Ear infection
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
4.0%
2/50 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Gastrointestinal disorders
Enteritis
|
4.0%
2/50 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
10.0%
5/50 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
14.0%
7/50 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Gastroenteritis
|
12.0%
6/50 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
12.0%
6/50 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
14.0%
7/50 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
10.0%
5/50 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Gastrointestinal fungal infection
|
8.0%
4/50 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
12.0%
6/50 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Psychiatric disorders
Irritability
|
18.0%
9/50 • Number of events 9 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
12.0%
6/50 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
4.0%
2/50 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Malaria
|
20.0%
10/50 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
26.0%
13/50 • Number of events 14 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
36.0%
18/50 • Number of events 19 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
36.0%
18/50 • Number of events 20 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
20.0%
10/50 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
16.0%
8/50 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Nasopharyngitis
|
14.0%
7/50 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
10.0%
5/50 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
16.0%
8/50 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
10.0%
5/50 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
General disorders
Pain
|
46.0%
23/50 • Number of events 30 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
52.0%
26/50 • Number of events 31 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
30.0%
15/50 • Number of events 17 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
30.0%
15/50 • Number of events 17 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
28.0%
14/50 • Number of events 16 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
18.0%
9/50 • Number of events 9 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
General disorders
Pyrexia
|
98.0%
49/50 • Number of events 143 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
94.0%
47/50 • Number of events 123 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
74.0%
37/50 • Number of events 63 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
70.0%
35/50 • Number of events 52 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
58.0%
29/50 • Number of events 33 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
42.0%
21/50 • Number of events 28 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Infections and infestations
Rhinitis
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
14.0%
7/50 • Number of events 7 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
10.0%
5/50 • Number of events 6 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
6.0%
3/50 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
8.0%
4/50 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
|
Congenital, familial and genetic disorders
Sickle cell anaemia with crisis
|
2.0%
1/50 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
6.0%
3/50 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
20.0%
10/50 • Number of events 13 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
0.00%
0/50 • Solicited local and general symptoms: during the 4-day (Days 0-3) period following each vaccination dose; Unsolicited AEs: within the 31-day (Days 0-30) period following each vaccination; SAEs: throughout the study, from Day 0 up to Month 9.
|
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