Trial Outcomes & Findings for Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants (NCT NCT01204658)
NCT ID: NCT01204658
Last Updated: 2019-05-29
Results Overview
Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to \[\>=\] 38 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (\>) 40.0°C. Primary results correspond to results for occurrences of G3 fever symptoms assessed by the investigators as related to vaccination (Related G3 fever).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
576 participants
Primary outcome timeframe
Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course
Results posted on
2019-05-29
Participant Flow
A total of 576 subjects were initially enrolled in the study. Of these, one subject was older than protocol defined age range for the first vaccination, and therefore did not receive any vaccination.
The study duration is approximately 10 to 14 months depending on age at recruitment and age at booster vaccination. 2 Phases in the study: Primary Phase when subjects received a 3-dose of pneumococcal vaccine co-administered with Infanrix hexa™ (Months 0, 1, 2), and Booster Phase when subjects received one dose of the same vaccines (Month 10).
Participant milestones
| Measure |
10PP-LD/Infanrix Hexa Group
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Primary Phase
STARTED
|
146
|
142
|
145
|
142
|
|
Primary Phase
COMPLETED
|
146
|
142
|
144
|
142
|
|
Primary Phase
NOT COMPLETED
|
0
|
0
|
1
|
0
|
|
Booster Phase
STARTED
|
144
|
140
|
140
|
140
|
|
Booster Phase
COMPLETED
|
144
|
140
|
140
|
140
|
|
Booster Phase
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
10PP-LD/Infanrix Hexa Group
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Primary Phase
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants
Baseline characteristics by cohort
| Measure |
10PP-LD/Infanrix Hexa Group
n=146 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=142 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=145 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=142 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
Total
n=575 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
10.3 Weeks
STANDARD_DEVIATION 2.49 • n=5 Participants
|
10.1 Weeks
STANDARD_DEVIATION 2.70 • n=7 Participants
|
10.1 Weeks
STANDARD_DEVIATION 2.61 • n=5 Participants
|
10.2 Weeks
STANDARD_DEVIATION 2.64 • n=4 Participants
|
10.2 Weeks
STANDARD_DEVIATION 2.61 • n=21 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
268 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
307 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination coursePopulation: The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.
Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to \[\>=\] 38 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (\>) 40.0°C. Primary results correspond to results for occurrences of G3 fever symptoms assessed by the investigators as related to vaccination (Related G3 fever).
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=146 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=142 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=144 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=142 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Any Irritability, post D1
|
93 Participants
|
82 Participants
|
89 Participants
|
82 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Any Loss Appet., post D1
|
38 Participants
|
32 Participants
|
39 Participants
|
32 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related Loss Appet., post D1
|
28 Participants
|
26 Participants
|
29 Participants
|
21 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related G3 Fever, post D1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
G3 Drowsiness, post D2
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
G3 Irritability, post D2
|
8 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Any Loss Appet., post D2
|
32 Participants
|
30 Participants
|
28 Participants
|
30 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related Loss Appet., post D2
|
23 Participants
|
21 Participants
|
18 Participants
|
25 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Any Fever, post D2
|
40 Participants
|
50 Participants
|
38 Participants
|
38 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
G3 Fever, post D2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related Fever, post D2
|
32 Participants
|
39 Participants
|
33 Participants
|
31 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Any Drowsiness, post D3
|
57 Participants
|
48 Participants
|
56 Participants
|
48 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related Drowsiness, post D3
|
51 Participants
|
38 Participants
|
44 Participants
|
36 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
G3 Irritability, post D3
|
7 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related Irritability, post D3
|
52 Participants
|
55 Participants
|
48 Participants
|
53 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Any Loss Appet., post D3
|
28 Participants
|
25 Participants
|
24 Participants
|
21 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Any Fever, post D3
|
28 Participants
|
23 Participants
|
27 Participants
|
30 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related Fever, post D3
|
23 Participants
|
19 Participants
|
20 Participants
|
22 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Any Drowsiness, post D1
|
82 Participants
|
76 Participants
|
72 Participants
|
77 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
G3 Drowsiness, post D1
|
4 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related Drowsiness, post D1
|
63 Participants
|
58 Participants
|
52 Participants
|
58 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
G3 Irritability, post D1
|
6 Participants
|
9 Participants
|
9 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related Irritability, post D1
|
70 Participants
|
62 Participants
|
66 Participants
|
57 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
G3 Loss Appet., post D1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Any Fever, post D1
|
45 Participants
|
32 Participants
|
53 Participants
|
28 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
G3 Fever, post D1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related Fever, post D1
|
33 Participants
|
25 Participants
|
44 Participants
|
27 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Any Drowsiness, post D2
|
71 Participants
|
63 Participants
|
70 Participants
|
66 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related Drowsiness, post D2
|
53 Participants
|
49 Participants
|
56 Participants
|
55 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Any Irritability, post D2
|
88 Participants
|
81 Participants
|
86 Participants
|
87 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related Irritability, post D2
|
69 Participants
|
66 Participants
|
66 Participants
|
67 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
G3 Loss Appet., post D2
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related G3 Fever, post D2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Grade 3 Drowsiness, post D3
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Any Irritability, post D3
|
62 Participants
|
73 Participants
|
62 Participants
|
72 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
G3 Loss Appet., post D3
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related Loss Appet., post D3
|
22 Participants
|
20 Participants
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
G3 Fever, post D3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
Related G3 Fever, post D3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.
Grade 3 fever was defined as fever by rectal measurement \> 40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-LD/Infanrix hexa (or 10PP-LD) and Synflorix/Infanrix hexa (or 10PN) groups only.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=146 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=144 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group
Fever>40.0°C & Related Dose 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group
Fever>40.0°C & Related Dose 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group
Fever>40.0°C & Related Dose 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group
Fever>40.0°C & Related across doses
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.
Grade 3 fever was defined as fever by rectal measurement \>40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-HD/Infanrix hexa (or 10PP-HD) and Synflorix/Infanrix hexa (or 10PN) groups only.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=142 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=144 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group
Fever>40.0°C & Related Dose 1
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group
Fever>40.0°C & Related Dose 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group
Fever>40.0°C & Related across doses
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
|
Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group
Fever>40.0°C & Related Dose 3
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Primary Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=130 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=134 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=136 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=131 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Primary Phase of the Study
Anti-dPly - At Month 3
|
9408.42 EL.U/mL
Interval 8182.15 to 10818.47
|
12137.96 EL.U/mL
Interval 10641.83 to 13844.44
|
459.97 EL.U/mL
Interval 398.31 to 531.18
|
472.88 EL.U/mL
Interval 404.48 to 552.86
|
|
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Primary Phase of the Study
Anti-PhtD - At Month 3
|
1456.57 EL.U/mL
Interval 1250.65 to 1696.39
|
1996.61 EL.U/mL
Interval 1734.17 to 2298.75
|
523.61 EL.U/mL
Interval 453.71 to 604.28
|
552.01 EL.U/mL
Interval 469.55 to 648.95
|
SECONDARY outcome
Timeframe: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Booster Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=130 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=129 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=129 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=129 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Booster Phase of the Study
Anti-dPly - Month 11
|
24720.40 EL.U/mL
Interval 21863.04 to 27951.19
|
29838.18 EL.U/mL
Interval 26892.53 to 33106.48
|
582.85 EL.U/mL
Interval 463.4 to 733.09
|
791.42 EL.U/mL
Interval 628.23 to 997.0
|
|
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Booster Phase of the Study
Anti-dPly - Month 10
|
6674.42 EL.U/mL
Interval 5628.57 to 7914.6
|
5592.85 EL.U/mL
Interval 4750.83 to 6584.1
|
495.02 EL.U/mL
Interval 393.19 to 623.22
|
737.71 EL.U/mL
Interval 587.67 to 926.06
|
|
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Booster Phase of the Study
Anti-PhtD - Month 10
|
910.80 EL.U/mL
Interval 718.85 to 1154.0
|
829.12 EL.U/mL
Interval 671.12 to 1024.32
|
209.27 EL.U/mL
Interval 153.16 to 285.95
|
381.66 EL.U/mL
Interval 274.64 to 530.39
|
|
Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Booster Phase of the Study
Anti-PhtD - Month 11
|
3528.25 EL.U/mL
Interval 2952.68 to 4216.01
|
3777.39 EL.U/mL
Interval 3181.74 to 4484.55
|
266.58 EL.U/mL
Interval 190.06 to 373.91
|
469.16 EL.U/mL
Interval 335.29 to 656.46
|
SECONDARY outcome
Timeframe: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Primary Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=132 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=134 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=137 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=132 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Antibody Concentrations Against Protein D (Anti-PD) - Primary Phase of the Study
|
1135.7 EL.U/mL
Interval 927.8 to 1390.1
|
1323.3 EL.U/mL
Interval 1099.7 to 1592.4
|
1539.0 EL.U/mL
Interval 1258.4 to 1882.1
|
147.0 EL.U/mL
Interval 112.3 to 192.3
|
SECONDARY outcome
Timeframe: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Booster Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=131 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=130 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=131 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=129 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Antibody Concentrations Against Protein D (Anti-PD) - Booster Phase of the Study
Anti-PD - Month 10
|
434.3 EL.U/mL
Interval 365.5 to 516.0
|
472.8 EL.U/mL
Interval 403.1 to 554.5
|
698.2 EL.U/mL
Interval 593.7 to 821.0
|
81.0 EL.U/mL
Interval 69.8 to 93.9
|
|
Antibody Concentrations Against Protein D (Anti-PD) - Booster Phase of the Study
Anti-PD - Month 11
|
1655.4 EL.U/mL
Interval 1398.2 to 1960.0
|
1631.0 EL.U/mL
Interval 1404.5 to 1894.2
|
2394.2 EL.U/mL
Interval 2045.7 to 2802.1
|
85.7 EL.U/mL
Interval 73.6 to 99.8
|
SECONDARY outcome
Timeframe: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. This outcome concerns results for the Primary Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=132 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=135 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=137 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=132 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-6B At Month 3
|
0.36 µg/mL
Interval 0.29 to 0.46
|
0.37 µg/mL
Interval 0.31 to 0.45
|
0.40 µg/mL
Interval 0.32 to 0.51
|
0.46 µg/mL
Interval 0.37 to 0.57
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-18C At Month 3
|
2.27 µg/mL
Interval 1.93 to 2.67
|
2.18 µg/mL
Interval 1.84 to 2.59
|
2.45 µg/mL
Interval 2.04 to 2.95
|
2.56 µg/mL
Interval 2.14 to 3.07
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-23F At Month 3
|
0.67 µg/mL
Interval 0.54 to 0.82
|
0.62 µg/mL
Interval 0.5 to 0.78
|
0.67 µg/mL
Interval 0.54 to 0.82
|
1.48 µg/mL
Interval 1.17 to 1.88
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-1 At Month 3
|
1.57 µg/mL
Interval 1.36 to 1.8
|
1.58 µg/mL
Interval 1.36 to 1.83
|
1.49 µg/mL
Interval 1.28 to 1.74
|
2.20 µg/mL
Interval 1.86 to 2.6
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-4 At Month 3
|
2.04 µg/mL
Interval 1.74 to 2.39
|
2.11 µg/mL
Interval 1.83 to 2.43
|
1.82 µg/mL
Interval 1.55 to 2.14
|
2.43 µg/mL
Interval 2.05 to 2.88
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-5 At Month 3
|
2.46 µg/mL
Interval 2.13 to 2.85
|
2.55 µg/mL
Interval 2.22 to 2.92
|
2.31 µg/mL
Interval 2.0 to 2.67
|
2.77 µg/mL
Interval 2.27 to 3.38
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-7F At Month 3
|
2.12 µg/mL
Interval 1.86 to 2.41
|
2.21 µg/mL
Interval 1.97 to 2.48
|
2.20 µg/mL
Interval 1.92 to 2.5
|
2.94 µg/mL
Interval 2.51 to 3.46
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-9V At Month 3
|
1.83 µg/mL
Interval 1.59 to 2.12
|
1.95 µg/mL
Interval 1.73 to 2.2
|
1.99 µg/mL
Interval 1.72 to 2.3
|
2.33 µg/mL
Interval 1.96 to 2.76
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-14 At Month 3
|
3.57 µg/mL
Interval 3.08 to 4.14
|
3.72 µg/mL
Interval 3.3 to 4.18
|
3.91 µg/mL
Interval 3.41 to 4.48
|
4.18 µg/mL
Interval 3.41 to 5.13
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-19F At Month 3
|
4.29 µg/mL
Interval 3.63 to 5.07
|
4.13 µg/mL
Interval 3.52 to 4.85
|
4.51 µg/mL
Interval 3.79 to 5.36
|
3.50 µg/mL
Interval 2.94 to 4.18
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-3 (At Month 3
|
0.05 µg/mL
Interval 0.04 to 0.06
|
0.06 µg/mL
Interval 0.05 to 0.07
|
0.05 µg/mL
Interval 0.05 to 0.06
|
2.47 µg/mL
Interval 2.08 to 2.93
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-6A At Month 3
|
0.13 µg/mL
Interval 0.1 to 0.16
|
0.11 µg/mL
Interval 0.09 to 0.14
|
0.11 µg/mL
Interval 0.09 to 0.14
|
2.05 µg/mL
Interval 1.69 to 2.5
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
ANTI-19A At Month 3
|
0.18 µg/mL
Interval 0.14 to 0.23
|
0.17 µg/mL
Interval 0.13 to 0.21
|
0.16 µg/mL
Interval 0.13 to 0.2
|
2.77 µg/mL
Interval 2.34 to 3.28
|
SECONDARY outcome
Timeframe: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns results for the Booster Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=130 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=131 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=131 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=129 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-14 Month 11
|
6.06 µg/mL
Interval 5.18 to 7.09
|
7.18 µg/mL
Interval 6.14 to 8.39
|
6.63 µg/mL
Interval 5.59 to 7.86
|
11.43 µg/mL
Interval 9.81 to 13.3
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-18C Month 10
|
0.75 µg/mL
Interval 0.64 to 0.87
|
0.76 µg/mL
Interval 0.65 to 0.89
|
0.92 µg/mL
Interval 0.77 to 1.1
|
0.75 µg/mL
Interval 0.65 to 0.85
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-19F Month 10
|
1.25 µg/mL
Interval 1.05 to 1.47
|
1.13 µg/mL
Interval 0.96 to 1.33
|
1.30 µg/mL
Interval 1.06 to 1.58
|
0.66 µg/mL
Interval 0.53 to 0.82
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-23F Month 10
|
0.46 µg/mL
Interval 0.38 to 0.56
|
0.47 µg/mL
Interval 0.38 to 0.58
|
0.57 µg/mL
Interval 0.48 to 0.68
|
0.37 µg/mL
Interval 0.3 to 0.44
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-9V Month 10
|
0.77 µg/mL
Interval 0.65 to 0.9
|
0.97 µg/mL
Interval 0.84 to 1.12
|
0.99 µg/mL
Interval 0.85 to 1.16
|
0.58 µg/mL
Interval 0.5 to 0.68
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-4 Month 10
|
0.50 µg/mL
Interval 0.43 to 0.58
|
0.51 µg/mL
Interval 0.43 to 0.61
|
0.58 µg/mL
Interval 0.49 to 0.7
|
0.40 µg/mL
Interval 0.35 to 0.46
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-5 Month 11
|
3.48 µg/mL
Interval 2.98 to 4.05
|
3.44 µg/mL
Interval 2.98 to 3.96
|
3.33 µg/mL
Interval 2.87 to 3.87
|
7.52 µg/mL
Interval 6.52 to 8.68
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-23F Month 11
|
3.20 µg/mL
Interval 2.68 to 3.83
|
3.20 µg/mL
Interval 2.7 to 3.78
|
3.72 µg/mL
Interval 3.21 to 4.31
|
7.10 µg/mL
Interval 6.05 to 8.35
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-3 Month 10
|
0.05 µg/mL
Interval 0.04 to 0.06
|
0.05 µg/mL
Interval 0.04 to 0.06
|
0.05 µg/mL
Interval 0.04 to 0.06
|
0.32 µg/mL
Interval 0.27 to 0.38
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-3 Month 11
|
0.06 µg/mL
Interval 0.05 to 0.08
|
0.05 µg/mL
Interval 0.04 to 0.07
|
0.06 µg/mL
Interval 0.05 to 0.07
|
1.83 µg/mL
Interval 1.58 to 2.12
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-6A Month 10
|
0.19 µg/mL
Interval 0.15 to 0.24
|
0.18 µg/mL
Interval 0.15 to 0.22
|
0.20 µg/mL
Interval 0.16 to 0.24
|
0.70 µg/mL
Interval 0.59 to 0.83
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-6A Month 11
|
0.89 µg/mL
Interval 0.72 to 1.11
|
0.74 µg/mL
Interval 0.59 to 0.93
|
0.99 µg/mL
Interval 0.78 to 1.26
|
7.77 µg/mL
Interval 6.6 to 9.14
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-1 Month 10
|
0.30 µg/mL
Interval 0.25 to 0.35
|
0.30 µg/mL
Interval 0.26 to 0.36
|
0.26 µg/mL
Interval 0.22 to 0.31
|
0.49 µg/mL
Interval 0.43 to 0.55
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-1 Month 11
|
2.62 µg/mL
Interval 2.27 to 3.04
|
2.61 µg/mL
Interval 2.27 to 3.0
|
2.41 µg/mL
Interval 2.06 to 2.82
|
3.78 µg/mL
Interval 3.34 to 4.28
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-4 Month 11
|
4.10 µg/mL
Interval 3.54 to 4.74
|
3.90 µg/mL
Interval 3.35 to 4.53
|
3.98 µg/mL
Interval 3.51 to 4.52
|
4.36 µg/mL
Interval 3.77 to 5.05
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-5 Month 10
|
0.59 µg/mL
Interval 0.5 to 0.69
|
0.58 µg/mL
Interval 0.49 to 0.68
|
0.55 µg/mL
Interval 0.47 to 0.65
|
0.85 µg/mL
Interval 0.74 to 0.99
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-6B Month 10
|
0.45 µg/mL
Interval 0.38 to 0.53
|
0.47 µg/mL
Interval 0.39 to 0.56
|
0.46 µg/mL
Interval 0.38 to 0.55
|
0.25 µg/mL
Interval 0.21 to 0.31
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-6B Month 11
|
2.04 µg/mL
Interval 1.77 to 2.36
|
1.96 µg/mL
Interval 1.67 to 2.3
|
2.28 µg/mL
Interval 1.94 to 2.68
|
3.11 µg/mL
Interval 2.65 to 3.64
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-7F Month 10
|
0.94 µg/mL
Interval 0.82 to 1.09
|
1.00 µg/mL
Interval 0.88 to 1.15
|
0.98 µg/mL
Interval 0.85 to 1.13
|
1.34 µg/mL
Interval 1.18 to 1.53
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-7F Month 11
|
4.72 µg/mL
Interval 4.13 to 5.4
|
4.70 µg/mL
Interval 4.19 to 5.27
|
4.87 µg/mL
Interval 4.32 to 5.5
|
7.68 µg/mL
Interval 6.84 to 8.61
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-9V Month 11
|
4.48 µg/mL
Interval 3.9 to 5.14
|
4.91 µg/mL
Interval 4.32 to 5.58
|
5.20 µg/mL
Interval 4.52 to 5.97
|
6.57 µg/mL
Interval 5.67 to 7.6
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-14 Month 10
|
1.36 µg/mL
Interval 1.12 to 1.65
|
1.43 µg/mL
Interval 1.18 to 1.73
|
1.57 µg/mL
Interval 1.28 to 1.93
|
2.06 µg/mL
Interval 1.72 to 2.47
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-18C Month 11
|
6.68 µg/mL
Interval 5.76 to 7.75
|
6.38 µg/mL
Interval 5.48 to 7.42
|
7.65 µg/mL
Interval 6.76 to 8.67
|
6.40 µg/mL
Interval 5.5 to 7.45
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-19F Month 11
|
6.73 µg/mL
Interval 5.77 to 7.83
|
7.22 µg/mL
Interval 6.25 to 8.33
|
7.84 µg/mL
Interval 6.78 to 9.06
|
7.43 µg/mL
Interval 6.35 to 8.69
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-19A Month 10
|
0.18 µg/mL
Interval 0.15 to 0.22
|
0.15 µg/mL
Interval 0.12 to 0.18
|
0.18 µg/mL
Interval 0.14 to 0.22
|
0.57 µg/mL
Interval 0.44 to 0.73
|
|
Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
ANTI-19A Month 11
|
1.12 µg/mL
Interval 0.89 to 1.41
|
1.03 µg/mL
Interval 0.8 to 1.31
|
1.23 µg/mL
Interval 0.99 to 1.52
|
7.77 µg/mL
Interval 6.43 to 9.39
|
SECONDARY outcome
Timeframe: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Primary Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=63 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=57 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=66 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=63 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-14 At Month 3
|
1405.3 Titers
Interval 1060.3 to 1862.4
|
1334.9 Titers
Interval 1013.9 to 1757.4
|
1575.3 Titers
Interval 1143.5 to 2170.1
|
2410.6 Titers
Interval 1516.6 to 3831.5
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-23F At Month 3
|
1275.6 Titers
Interval 771.1 to 2110.3
|
2170.3 Titers
Interval 1559.9 to 3019.6
|
1757.9 Titers
Interval 1191.4 to 2593.7
|
4437.1 Titers
Interval 2874.9 to 6848.2
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-3 (At Month 3
|
5.0 Titers
Interval 3.9 to 6.4
|
4.5 Titers
Interval 3.9 to 5.2
|
4.6 Titers
Interval 4.0 to 5.3
|
88.4 Titers
Interval 67.3 to 116.0
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-1 At Month 3
|
38.6 Titers
Interval 24.6 to 60.5
|
27.8 Titers
Interval 17.5 to 44.2
|
29.4 Titers
Interval 19.4 to 44.5
|
68.9 Titers
Interval 47.5 to 99.9
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-4 At Month 3
|
703.7 Titers
Interval 533.5 to 928.2
|
844.4 Titers
Interval 660.8 to 1079.0
|
819.2 Titers
Interval 652.7 to 1028.1
|
748.1 Titers
Interval 509.9 to 1097.5
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-5 At Month 3
|
47.3 Titers
Interval 33.6 to 66.6
|
60.6 Titers
Interval 44.1 to 83.3
|
50.3 Titers
Interval 37.2 to 68.1
|
72.9 Titers
Interval 52.2 to 101.8
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-6B At Month 3
|
399.6 Titers
Interval 249.4 to 640.4
|
454.7 Titers
Interval 299.8 to 689.7
|
409.7 Titers
Interval 251.0 to 668.7
|
884.9 Titers
Interval 569.3 to 1375.5
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-7F At Month 3
|
3212.6 Titers
Interval 2434.8 to 4238.8
|
3697.6 Titers
Interval 2748.6 to 4974.1
|
4234.2 Titers
Interval 3203.0 to 5597.4
|
7394.5 Titers
Interval 4411.1 to 12395.7
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-9V At Month 3
|
1942.4 Titers
Interval 1381.9 to 2730.1
|
1520.7 Titers
Interval 1109.4 to 2084.5
|
1983.6 Titers
Interval 1507.2 to 2610.7
|
2242.8 Titers
Interval 1474.7 to 3411.1
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-18C At Month 3
|
108.1 Titers
Interval 72.6 to 161.2
|
102.7 Titers
Interval 70.3 to 150.0
|
169.4 Titers
Interval 121.9 to 235.4
|
257.6 Titers
Interval 179.4 to 369.9
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-19F At Month 3
|
211.6 Titers
Interval 139.6 to 320.7
|
344.1 Titers
Interval 240.6 to 492.0
|
381.6 Titers
Interval 256.8 to 566.9
|
142.5 Titers
Interval 98.9 to 205.4
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-6A At Month 3
|
43.2 Titers
Interval 23.8 to 78.5
|
59.6 Titers
Interval 35.4 to 100.3
|
44.7 Titers
Interval 26.2 to 76.2
|
1726.0 Titers
Interval 1113.9 to 2674.4
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
OPA-19A At Month 3
|
576.0 Titers
Interval 340.6 to 974.3
|
914.6 Titers
Interval 586.8 to 1425.6
|
905.2 Titers
Interval 628.2 to 1304.5
|
2915.3 Titers
Interval 2270.3 to 3743.6
|
SECONDARY outcome
Timeframe: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Booster Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=68 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=58 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=68 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=62 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-1 Month 10
|
12.4 Titers
Interval 7.6 to 20.1
|
13.2 Titers
Interval 8.3 to 21.1
|
18.7 Titers
Interval 11.2 to 31.4
|
10.3 Titers
Interval 6.8 to 15.5
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-6B Month 10
|
103.2 Titers
Interval 56.5 to 188.4
|
174.5 Titers
Interval 102.1 to 298.2
|
136.9 Titers
Interval 76.1 to 246.4
|
113.8 Titers
Interval 59.3 to 218.6
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-19F Month 10
|
18.0 Titers
Interval 11.2 to 29.0
|
31.0 Titers
Interval 19.2 to 49.9
|
30.7 Titers
Interval 19.2 to 49.2
|
7.4 Titers
Interval 4.8 to 11.5
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-19F Month 11
|
650.2 Titers
Interval 444.1 to 951.9
|
778.9 Titers
Interval 500.4 to 1212.3
|
1053.9 Titers
Interval 812.6 to 1366.8
|
767.1 Titers
Interval 582.1 to 1010.9
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-23F Month 11
|
3621.0 Titers
Interval 2534.5 to 5173.2
|
2563.6 Titers
Interval 1831.6 to 3588.2
|
4465.4 Titers
Interval 3368.6 to 5919.3
|
32508.0 Titers
Interval 23754.9 to 44486.3
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-3 Month 10
|
6.7 Titers
Interval 4.7 to 9.5
|
8.3 Titers
Interval 4.9 to 14.0
|
6.3 Titers
Interval 4.6 to 8.8
|
12.0 Titers
Interval 7.6 to 19.1
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-1 Month 11
|
373.5 Titers
Interval 253.3 to 550.8
|
369.2 Titers
Interval 252.8 to 539.4
|
300.0 Titers
Interval 213.2 to 422.1
|
369.3 Titers
Interval 281.4 to 484.6
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-4 Month 10
|
36.2 Titers
Interval 19.1 to 68.4
|
48.3 Titers
Interval 25.6 to 91.0
|
122.3 Titers
Interval 75.0 to 199.6
|
18.5 Titers
Interval 9.7 to 35.4
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-4 Month 11
|
1370.7 Titers
Interval 1034.2 to 1816.6
|
1634.8 Titers
Interval 1284.8 to 2080.3
|
2043.3 Titers
Interval 1609.1 to 2594.6
|
2882.6 Titers
Interval 2252.4 to 3689.1
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-5 Month 10
|
9.3 Titers
Interval 6.9 to 12.5
|
10.5 Titers
Interval 6.9 to 16.1
|
9.5 Titers
Interval 6.9 to 12.9
|
8.7 Titers
Interval 6.3 to 12.0
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-5 Month 11
|
154.5 Titers
Interval 111.8 to 213.4
|
166.8 Titers
Interval 118.4 to 234.8
|
139.3 Titers
Interval 102.3 to 189.8
|
327.4 Titers
Interval 254.2 to 421.8
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-6B Month 11
|
802.1 Titers
Interval 531.7 to 1210.0
|
700.3 Titers
Interval 481.3 to 1018.8
|
1013.8 Titers
Interval 744.6 to 1380.3
|
2731.1 Titers
Interval 1972.7 to 3781.1
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-7F Month 10
|
795.5 Titers
Interval 560.1 to 1129.9
|
886.4 Titers
Interval 599.1 to 1311.5
|
1322.5 Titers
Interval 961.5 to 1819.1
|
1895.8 Titers
Interval 1420.6 to 2530.0
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-7F Month 11
|
5819.9 Titers
Interval 4473.1 to 7572.2
|
5733.8 Titers
Interval 4165.0 to 7893.5
|
8336.9 Titers
Interval 6357.9 to 10931.8
|
18012.3 Titers
Interval 13872.4 to 23387.7
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-9V Month 10
|
281.5 Titers
Interval 175.4 to 451.7
|
340.8 Titers
Interval 224.0 to 518.5
|
433.7 Titers
Interval 318.3 to 591.0
|
510.4 Titers
Interval 344.6 to 755.8
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-9V Month 11
|
2001.6 Titers
Interval 1506.6 to 2659.3
|
2436.5 Titers
Interval 1734.5 to 3422.6
|
3711.7 Titers
Interval 2881.2 to 4781.4
|
6839.2 Titers
Interval 5464.7 to 8559.3
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-14 Month 10
|
275.8 Titers
Interval 175.2 to 434.3
|
208.1 Titers
Interval 111.9 to 386.9
|
355.6 Titers
Interval 216.3 to 584.8
|
483.0 Titers
Interval 286.9 to 813.1
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-14 Month 11
|
2216.9 Titers
Interval 1678.0 to 2928.9
|
2297.4 Titers
Interval 1640.0 to 3218.4
|
2488.9 Titers
Interval 1942.5 to 3189.0
|
3545.0 Titers
Interval 2465.2 to 5097.8
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-18C Month 10
|
5.1 Titers
Interval 4.0 to 6.6
|
6.3 Titers
Interval 4.6 to 8.7
|
6.7 Titers
Interval 4.9 to 9.0
|
4.8 Titers
Interval 3.9 to 6.1
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-18C Month 11
|
374.6 Titers
Interval 271.2 to 517.4
|
303.6 Titers
Interval 197.7 to 466.3
|
511.0 Titers
Interval 356.7 to 732.2
|
464.4 Titers
Interval 327.7 to 658.1
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-23F Month 10
|
189.6 Titers
Interval 83.5 to 430.5
|
281.4 Titers
Interval 123.2 to 642.8
|
242.5 Titers
Interval 106.5 to 552.2
|
367.4 Titers
Interval 150.3 to 897.8
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-3 Month 11
|
7.8 Titers
Interval 5.7 to 10.6
|
7.8 Titers
Interval 5.4 to 11.2
|
9.2 Titers
Interval 6.8 to 12.5
|
333.9 Titers
Interval 260.3 to 428.3
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-6A Month 10
|
26.5 Titers
Interval 13.2 to 52.9
|
23.3 Titers
Interval 10.3 to 53.1
|
18.7 Titers
Interval 9.8 to 35.7
|
129.7 Titers
Interval 61.2 to 274.7
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-6A Month 11
|
163.1 Titers
Interval 94.0 to 283.1
|
190.0 Titers
Interval 106.6 to 338.4
|
276.2 Titers
Interval 174.8 to 436.6
|
4855.3 Titers
Interval 3606.3 to 6536.8
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-19A Month 10
|
211.8 Titers
Interval 139.2 to 322.4
|
262.0 Titers
Interval 157.8 to 435.1
|
315.6 Titers
Interval 193.5 to 514.6
|
776.3 Titers
Interval 542.2 to 1111.7
|
|
Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
OPA-19A Month 11
|
2006.3 Titers
Interval 1539.1 to 2615.3
|
2609.5 Titers
Interval 1919.1 to 3548.2
|
2699.1 Titers
Interval 2262.2 to 3220.5
|
7137.0 Titers
Interval 5909.4 to 8619.6
|
SECONDARY outcome
Timeframe: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: This analysis could not be performed as no validated assay was available.
Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Primary Phase of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: This analysis could not be performed as no validated assay was available.
Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Booster Phase of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Primary Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=59 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=54 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=57 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=60 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Primary Phase of the Study
ANTI-D At Month 3
|
3.251 IU/mL
Interval 2.729 to 3.873
|
3.185 IU/mL
Interval 2.556 to 3.968
|
3.353 IU/mL
Interval 2.756 to 4.08
|
2.933 IU/mL
Interval 2.464 to 3.492
|
|
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Primary Phase of the Study
ANTI-T At Month 3
|
2.579 IU/mL
Interval 2.187 to 3.041
|
2.193 IU/mL
Interval 1.819 to 2.643
|
2.252 IU/mL
Interval 1.93 to 2.627
|
1.416 IU/mL
Interval 1.166 to 1.719
|
SECONDARY outcome
Timeframe: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Booster Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=45 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=50 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=46 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=49 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Booster Phase of the Study
ANTI-T At Month 11
|
8.725 IU/mL
Interval 7.259 to 10.488
|
8.703 IU/mL
Interval 7.415 to 10.215
|
9.929 IU/mL
Interval 8.653 to 11.394
|
5.040 IU/mL
Interval 4.074 to 6.234
|
|
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Booster Phase of the Study
ANTI-D At Month 10
|
0.731 IU/mL
Interval 0.575 to 0.929
|
0.587 IU/mL
Interval 0.461 to 0.747
|
0.651 IU/mL
Interval 0.507 to 0.836
|
0.614 IU/mL
Interval 0.497 to 0.758
|
|
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Booster Phase of the Study
ANTI-D At Month 11
|
9.872 IU/mL
Interval 8.191 to 11.898
|
8.688 IU/mL
Interval 7.026 to 10.743
|
9.742 IU/mL
Interval 7.991 to 11.878
|
8.290 IU/mL
Interval 6.943 to 9.899
|
|
Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Booster Phase of the Study
ANTI-T At Month 10
|
0.815 IU/mL
Interval 0.665 to 0.999
|
0.727 IU/mL
Interval 0.57 to 0.927
|
0.726 IU/mL
Interval 0.604 to 0.874
|
0.371 IU/mL
Interval 0.28 to 0.493
|
SECONDARY outcome
Timeframe: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the primary Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=59 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=54 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=57 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=60 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Primary Phase of the Study
ANTI-PT At Month 3
|
69.0 EL.U/mL
Interval 59.9 to 79.4
|
64.3 EL.U/mL
Interval 54.8 to 75.3
|
70.0 EL.U/mL
Interval 61.6 to 79.4
|
64.6 EL.U/mL
Interval 53.2 to 78.3
|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Primary Phase of the Study
ANTI-FHA At Month 3
|
187.9 EL.U/mL
Interval 159.0 to 222.1
|
178.1 EL.U/mL
Interval 150.2 to 211.2
|
157.1 EL.U/mL
Interval 132.5 to 186.3
|
188.6 EL.U/mL
Interval 156.4 to 227.5
|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Primary Phase of the Study
ANTI-PRN At Month 3
|
95.1 EL.U/mL
Interval 79.2 to 114.4
|
79.5 EL.U/mL
Interval 63.6 to 99.2
|
91.4 EL.U/mL
Interval 75.2 to 111.1
|
87.2 EL.U/mL
Interval 70.6 to 107.5
|
SECONDARY outcome
Timeframe: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the Booster Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=45 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=50 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=46 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=49 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study
ANTI-PRN At Month 10
|
21.8 EL.U/mL
Interval 15.8 to 30.1
|
16.1 EL.U/mL
Interval 11.7 to 22.2
|
14.3 EL.U/mL
Interval 10.7 to 19.3
|
14.3 EL.U/mL
Interval 10.6 to 19.3
|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study
ANTI-PT At Month 10
|
17.5 EL.U/mL
Interval 13.4 to 22.9
|
12.7 EL.U/mL
Interval 9.9 to 16.3
|
12.1 EL.U/mL
Interval 9.7 to 15.1
|
12.2 EL.U/mL
Interval 9.6 to 15.5
|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study
ANTI-PT At Month 11
|
93.8 EL.U/mL
Interval 75.4 to 116.6
|
90.6 EL.U/mL
Interval 73.5 to 111.7
|
95.7 EL.U/mL
Interval 80.1 to 114.3
|
85.2 EL.U/mL
Interval 70.3 to 103.2
|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study
ANTI-FHA At Month 10
|
63.0 EL.U/mL
Interval 50.3 to 78.9
|
51.7 EL.U/mL
Interval 40.1 to 66.6
|
48.5 EL.U/mL
Interval 38.3 to 61.5
|
54.2 EL.U/mL
Interval 42.5 to 69.2
|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study
ANTI-FHA At Month 11
|
359.4 EL.U/mL
Interval 291.3 to 443.5
|
380.1 EL.U/mL
Interval 311.9 to 463.2
|
308.4 EL.U/mL
Interval 252.0 to 377.3
|
376.7 EL.U/mL
Interval 322.6 to 439.8
|
|
Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study
ANTI-PRN At Month 11
|
294.8 EL.U/mL
Interval 227.0 to 382.8
|
228.5 EL.U/mL
Interval 174.2 to 299.7
|
224.2 EL.U/mL
Interval 180.0 to 279.1
|
197.3 EL.U/mL
Interval 154.3 to 252.2
|
SECONDARY outcome
Timeframe: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Primary Phase of the study. Note that the percentage of subjects with concentration ≥10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=50 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=43 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=47 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=48 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Primary Phase of the Study
|
676.7 mIU/mL
Interval 466.2 to 982.3
|
619.1 mIU/mL
Interval 386.5 to 991.5
|
719.8 mIU/mL
Interval 537.0 to 965.0
|
877.4 mIU/mL
Interval 597.0 to 1289.4
|
SECONDARY outcome
Timeframe: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Booster Phase of the study. \* A decrease in the specificity of the anti-HB Enzyme-Linked ImmunoSorbent Assay (ELISA) assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete reanalysis. The retest has been performed in using Food and Drug Administration (FDA)-approved ChemiLuminescence ImmunoAssay (CLIA) commercial assay Centaur™.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=60 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=65 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=62 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=64 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Booster Phase of the Study
ANTI-HBs At Month 10
|
299.2 mIU/mL
Interval 199.0 to 449.8
|
287.1 mIU/mL
Interval 195.1 to 422.4
|
166.6 mIU/mL
Interval 105.2 to 263.8
|
174.5 mIU/mL
Interval 113.5 to 268.2
|
|
Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Booster Phase of the Study
ANTI-HBs At Month 11
|
4110.9 mIU/mL
Interval 2576.5 to 6558.9
|
4234.8 mIU/mL
Interval 2961.4 to 6055.7
|
3142.4 mIU/mL
Interval 2151.1 to 4590.6
|
3116.4 mIU/mL
Interval 2142.5 to 4533.0
|
SECONDARY outcome
Timeframe: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Primary Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=59 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=54 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=57 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=60 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Primary Phase of the Study
|
1.920 µg/mL
Interval 1.433 to 2.573
|
1.975 µg/mL
Interval 1.39 to 2.806
|
1.813 µg/mL
Interval 1.33 to 2.472
|
0.963 µg/mL
Interval 0.69 to 1.344
|
SECONDARY outcome
Timeframe: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Booster Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=45 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=50 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=46 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=49 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Booster Phase of the Study
ANTI-PRP At Month 10
|
0.390 µg/mL
Interval 0.279 to 0.546
|
0.446 µg/mL
Interval 0.306 to 0.651
|
0.503 µg/mL
Interval 0.36 to 0.703
|
0.272 µg/mL
Interval 0.193 to 0.384
|
|
Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Booster Phase of the Study
ANTI-PRP At Month 11
|
16.961 µg/mL
Interval 11.652 to 24.689
|
28.168 µg/mL
Interval 20.58 to 38.554
|
24.549 µg/mL
Interval 16.379 to 36.795
|
12.853 µg/mL
Interval 8.301 to 19.899
|
SECONDARY outcome
Timeframe: At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=45 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=37 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=43 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=42 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Primary Phase of the Study
ANTI-Polio 1 At Month 3
|
175.7 Titers
Interval 124.5 to 247.8
|
138.2 Titers
Interval 91.0 to 209.8
|
190.3 Titers
Interval 115.7 to 312.9
|
173.7 Titers
Interval 128.9 to 234.0
|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Primary Phase of the Study
ANTI-Polio 2 At Month 3
|
134.3 Titers
Interval 86.3 to 209.1
|
114.7 Titers
Interval 68.6 to 192.0
|
177.6 Titers
Interval 102.5 to 307.8
|
148.4 Titers
Interval 101.1 to 217.9
|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Primary Phase of the Study
ANTI-Polio 3 At Month 3
|
445.7 Titers
Interval 290.9 to 682.9
|
432.2 Titers
Interval 273.0 to 684.3
|
552.7 Titers
Interval 361.1 to 846.1
|
538.6 Titers
Interval 413.6 to 701.4
|
SECONDARY outcome
Timeframe: At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)Population: The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=42 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=46 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=36 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=43 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study
ANTI-Polio 1 At Month 11
|
1116.0 Titers
Interval 696.1 to 1789.3
|
1222.0 Titers
Interval 737.1 to 2026.1
|
1149.6 Titers
Interval 764.3 to 1729.0
|
1233.2 Titers
Interval 898.9 to 1691.9
|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study
ANTI-Polio 3 At Month 11
|
2995.8 Titers
Interval 2081.1 to 4312.6
|
3626.3 Titers
Interval 2623.6 to 5012.2
|
2696.8 Titers
Interval 1913.7 to 3800.4
|
2820.0 Titers
Interval 2127.9 to 3737.4
|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study
ANTI-Polio 1 At Month 10
|
41.7 Titers
Interval 25.9 to 67.3
|
58.3 Titers
Interval 35.6 to 95.6
|
55.5 Titers
Interval 33.9 to 90.9
|
55.4 Titers
Interval 38.3 to 80.1
|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study
ANTI-Polio 2 At Month 10
|
50.4 Titers
Interval 33.4 to 76.0
|
55.9 Titers
Interval 35.6 to 87.8
|
61.0 Titers
Interval 40.2 to 92.7
|
66.8 Titers
Interval 48.6 to 91.9
|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study
ANTI-Polio 2 At Month 11
|
1998.1 Titers
Interval 1415.0 to 2821.5
|
2332.2 Titers
Interval 1739.0 to 3127.6
|
2048.3 Titers
Interval 1484.6 to 2825.9
|
2284.8 Titers
Interval 1705.1 to 3061.6
|
|
Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study
ANTI-Polio 3 At Month 10
|
167.7 Titers
Interval 113.3 to 248.3
|
104.9 Titers
Interval 68.7 to 160.2
|
125.4 Titers
Interval 81.2 to 193.6
|
93.1 Titers
Interval 66.2 to 130.9
|
SECONDARY outcome
Timeframe: Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination coursePopulation: The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.
Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm).
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=146 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=142 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=144 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=142 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Any Swelling, post D1
|
47 Participants
|
46 Participants
|
34 Participants
|
37 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Grade 3 Swelling, post D1
|
3 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Any Pain, post D1
|
52 Participants
|
46 Participants
|
53 Participants
|
40 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Grade 3 Pain, post D1
|
0 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Any Redness, post D1
|
59 Participants
|
58 Participants
|
52 Participants
|
51 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Grade 3 Redness, post D1
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Any Pain, post D2
|
52 Participants
|
49 Participants
|
42 Participants
|
43 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Grade 3 Pain, post D2
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Any Redness, post D2
|
67 Participants
|
67 Participants
|
63 Participants
|
59 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Grade 3 Redness, post D2
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Any Swelling, post D2
|
49 Participants
|
56 Participants
|
43 Participants
|
38 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Grade 3 Swelling, post D2
|
5 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Any Pain, post D3
|
41 Participants
|
35 Participants
|
37 Participants
|
45 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Grade 3 Pain, post D3
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Any Redness, post D3
|
65 Participants
|
65 Participants
|
58 Participants
|
65 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Grade 3 Redness, post D3
|
3 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Any Swelling, post D3
|
52 Participants
|
52 Participants
|
43 Participants
|
43 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
Grade 3 Swelling, post D3
|
6 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Within the 7-day (Days 0-6) period after booster vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.
Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (\>) 30 millimeters (mm).
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=144 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=140 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=139 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=140 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study
Any Redness
|
83 Participants
|
81 Participants
|
68 Participants
|
66 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study
Grade 3 Redness
|
11 Participants
|
15 Participants
|
12 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study
Any Swelling
|
70 Participants
|
55 Participants
|
49 Participants
|
59 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study
Grade 3 Swelling
|
8 Participants
|
8 Participants
|
7 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study
Any Pain
|
77 Participants
|
73 Participants
|
61 Participants
|
68 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study
Grade 3 Pain
|
7 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Within the 7-day (Days 0-6) period post vaccination after booster vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.
Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than \[≥\] 38 degrees Celsius \[°C\]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Axillary temperature higher than (\>) 40.0°C.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=144 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=140 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=139 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=140 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
Related Irritability
|
86 Participants
|
82 Participants
|
76 Participants
|
83 Participants
|
|
Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
Any Drowsiness
|
77 Participants
|
64 Participants
|
66 Participants
|
73 Participants
|
|
Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
Grade 3 Drowsiness
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
Related Drowsiness
|
68 Participants
|
61 Participants
|
59 Participants
|
69 Participants
|
|
Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
Any Irritability
|
95 Participants
|
84 Participants
|
82 Participants
|
90 Participants
|
|
Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
Grade 3 Irritability
|
12 Participants
|
8 Participants
|
4 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
Any Loss Appet
|
49 Participants
|
38 Participants
|
36 Participants
|
57 Participants
|
|
Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
Grade 3 Loss Appet.
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
Related Loss Appet.
|
42 Participants
|
38 Participants
|
33 Participants
|
49 Participants
|
|
Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
Any Fever
|
50 Participants
|
55 Participants
|
51 Participants
|
53 Participants
|
|
Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
Grade 3 Fever
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
Related Fever
|
44 Participants
|
52 Participants
|
45 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) period post primary vaccination, across dosesPopulation: The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.
An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=146 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=142 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=145 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=142 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Phase of the Study
|
55 Participants
|
68 Participants
|
64 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) period post booster vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort of Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases.
An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=144 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=140 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=140 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=140 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Phase of the Study
|
40 Participants
|
26 Participants
|
27 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: During the entire study period (Months 0-11)Population: The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.
An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.
Outcome measures
| Measure |
10PP-LD/Infanrix Hexa Group
n=146 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=142 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=145 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=142 Participants
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
13 Participants
|
9 Participants
|
21 Participants
|
17 Participants
|
Adverse Events
10PP-LD/Infanrix Hexa Group
Serious events: 13 serious events
Other events: 141 other events
Deaths: 0 deaths
10PP-HD/Infanrix Hexa Group
Serious events: 9 serious events
Other events: 137 other events
Deaths: 0 deaths
Synflorix/Infanrix Hexa Group
Serious events: 21 serious events
Other events: 139 other events
Deaths: 0 deaths
Prevnar 13/Infanrix Hexa Group
Serious events: 17 serious events
Other events: 134 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10PP-LD/Infanrix Hexa Group
n=146 participants at risk
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=142 participants at risk
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=145 participants at risk
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=142 participants at risk
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.68%
1/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
1.4%
2/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
2.1%
3/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Otitis media
|
2.1%
3/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Pneumonia
|
1.4%
2/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
2.1%
3/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Gastroenteritis
|
0.68%
1/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.68%
1/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
1.4%
2/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.68%
1/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.68%
1/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Bacterial infection
|
0.68%
1/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
1.4%
2/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Congenital, familial and genetic disorders
Phimosis
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Psychiatric disorders
Psychomotor retardation
|
0.68%
1/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Urinary tract infection
|
0.68%
1/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product by child
|
0.68%
1/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Psychiatric disorders
Breath holding
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Exanthema subitum
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Vascular disorders
Haematoma
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Nervous system disorders
Hypotonia
|
0.68%
1/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Nervous system disorders
Hypotonic-hyporesponsive episode
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
General disorders
Localised oedema
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.69%
1/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.68%
1/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Viral infection
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.70%
1/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
0.00%
0/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
Other adverse events
| Measure |
10PP-LD/Infanrix Hexa Group
n=146 participants at risk
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
10PP-HD/Infanrix Hexa Group
n=142 participants at risk
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
|
Synflorix/Infanrix Hexa Group
n=145 participants at risk
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
|
Prevnar 13/Infanrix Hexa Group
n=142 participants at risk
This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
|
|---|---|---|---|---|
|
General disorders
Pain
|
53.5%
77/144 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
52.1%
73/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
43.9%
61/139 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
48.6%
68/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
General disorders
Redness
|
57.6%
83/144 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
57.9%
81/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
48.9%
68/139 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
47.1%
66/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
General disorders
Swelling
|
48.6%
70/144 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
39.3%
55/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
35.3%
49/139 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
42.1%
59/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
General disorders
Drowsiness
|
53.5%
77/144 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
45.7%
64/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
47.5%
66/139 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
52.1%
73/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
General disorders
Irritability
|
66.0%
95/144 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
60.0%
84/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
59.0%
82/139 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
64.3%
90/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
General disorders
Loss of appetite
|
34.0%
49/144 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
27.1%
38/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
25.9%
36/139 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
40.7%
57/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
General disorders
Fever (rectal temperature >= 38°C)
|
34.7%
50/144 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
39.3%
55/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
36.7%
51/139 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
37.9%
53/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Eye disorders
Conjunctivitis
|
3.4%
5/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
6.3%
9/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
3.4%
5/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
2.1%
3/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Bronchitis
|
4.1%
6/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
8.5%
12/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
7.6%
11/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
9.2%
13/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
9/144 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
2.9%
4/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
2.1%
3/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
4.3%
6/140 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Rhinitis
|
7.5%
11/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
7.7%
11/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
8.3%
12/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
9.9%
14/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
|
Infections and infestations
Viral infection
|
0.00%
0/146 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
6.3%
9/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
3.4%
5/145 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
2.1%
3/142 • Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
Solicited symptoms results are presented only for subjects for whom results were available.
|
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