Trial Outcomes & Findings for Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination (NCT NCT00985751)
NCT ID: NCT00985751
Last Updated: 2020-11-05
Results Overview
The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
257 participants
Primary outcome timeframe
Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination
Results posted on
2020-11-05
Participant Flow
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participant milestones
| Measure |
GSK 2189242A-LD Group
Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
GSK 2189242A-HD Group
Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-LD Group
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
51
|
52
|
52
|
51
|
51
|
|
Overall Study
COMPLETED
|
51
|
52
|
52
|
51
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
GSK 2189242A-LD Group
Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
GSK 2189242A-HD Group
Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-LD Group
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination
Baseline characteristics by cohort
| Measure |
GSK 2189242A-LD Group
n=51 Participants
Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
GSK 2189242A-HD Group
n=52 Participants
Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-LD Group
n=52 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Total
n=257 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
17 Months
STANDARD_DEVIATION 3.6 • n=5 Participants
|
16.7 Months
STANDARD_DEVIATION 3.81 • n=7 Participants
|
17.1 Months
STANDARD_DEVIATION 4.03 • n=5 Participants
|
16.8 Months
STANDARD_DEVIATION 3.96 • n=4 Participants
|
16.3 Months
STANDARD_DEVIATION 4.18 • n=21 Participants
|
16.78 Months
STANDARD_DEVIATION 3.90 • n=10 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
127 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
130 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White-Caucasian/European heritage
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
254 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
White-Arabic/North African heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.
Outcome measures
| Measure |
Synflorix Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A Group
n=103 Participants
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
|
Synflorix/GSK 2189242A-LD Group
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Number of Subjects With Fever > 40.0°C (Rectal Temperature)
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccinationPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
The number of subjects with rectal temperature higher (\>) than 40.0 degrees Celsius (°C) is reported.
Outcome measures
| Measure |
Synflorix Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A Group
n=103 Participants
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
|
Synflorix/GSK 2189242A-LD Group
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Number of Subjects With Fever > 40.0°C (Rectal Temperature)
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.
Solicited local symptoms assessed include pain, redness and swelling. Grade 3 pain was defined as crying when limb was moved/spontaneously painful. Grade 3 swelling/redness was defined as swelling/redness larger than (\>) 30 millimeters (mm). "Any" is defined as incidence of the specified symptom regardless of intensity.
Outcome measures
| Measure |
Synflorix Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A Group
n=52 Participants
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
|
Synflorix/GSK 2189242A-LD Group
n=52 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness Booster
|
19 Participants
|
20 Participants
|
28 Participants
|
22 Participants
|
21 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness Booster
|
2 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling Booster
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain Dose 1
|
18 Participants
|
15 Participants
|
31 Participants
|
23 Participants
|
26 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Dose 1
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness Dose 1
|
17 Participants
|
20 Participants
|
32 Participants
|
28 Participants
|
25 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness Dose 1
|
1 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling Dose 1
|
8 Participants
|
5 Participants
|
19 Participants
|
17 Participants
|
19 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling Dose 1
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain Dose 2
|
15 Participants
|
22 Participants
|
24 Participants
|
27 Participants
|
27 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Dose 2
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Redness Dose 2
|
21 Participants
|
25 Participants
|
23 Participants
|
22 Participants
|
24 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Redness Dose 2
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling Dose 2
|
11 Participants
|
9 Participants
|
18 Participants
|
11 Participants
|
16 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Swelling Dose 2
|
0 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Pain Booster
|
18 Participants
|
22 Participants
|
32 Participants
|
26 Participants
|
25 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Grade 3 Pain Booster
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Any Swelling Booster
|
11 Participants
|
8 Participants
|
18 Participants
|
15 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.
Solicited general symptoms assessed include drowsiness, fever (defined as rectally temperature ≥ 38.0°C), irritability, and loss of appetite. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectally temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability = crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite = not eating at all. "Any" is defined as incidence of the specified symptom regardless of intensity or relationship to study vaccination.
Outcome measures
| Measure |
Synflorix Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A Group
n=52 Participants
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
|
Synflorix/GSK 2189242A-LD Group
n=52 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability Dose 1
|
21 Participants
|
16 Participants
|
31 Participants
|
27 Participants
|
23 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability Dose 1
|
6 Participants
|
9 Participants
|
17 Participants
|
16 Participants
|
14 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Dose 1
|
15 Participants
|
7 Participants
|
14 Participants
|
12 Participants
|
14 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Dose 1
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Dose 1
|
4 Participants
|
5 Participants
|
9 Participants
|
3 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever Dose 1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fever Dose 1
|
3 Participants
|
2 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Dose 2
|
12 Participants
|
16 Participants
|
17 Participants
|
15 Participants
|
23 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Dose 2
|
6 Participants
|
11 Participants
|
11 Participants
|
10 Participants
|
18 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Booster
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Booster
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Dose 1
|
16 Participants
|
13 Participants
|
24 Participants
|
20 Participants
|
26 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Drowsiness Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Dose 1
|
6 Participants
|
6 Participants
|
13 Participants
|
10 Participants
|
16 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fever Dose 1
|
7 Participants
|
8 Participants
|
14 Participants
|
12 Participants
|
12 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability Dose 2
|
12 Participants
|
18 Participants
|
22 Participants
|
24 Participants
|
27 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability Dose 2
|
3 Participants
|
11 Participants
|
17 Participants
|
18 Participants
|
21 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Dose 2
|
8 Participants
|
10 Participants
|
12 Participants
|
9 Participants
|
13 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Loss of appetite Dose 2
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Dose 2
|
4 Participants
|
5 Participants
|
9 Participants
|
5 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fever Dose 2
|
9 Participants
|
12 Participants
|
8 Participants
|
9 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fever Dose 2
|
2 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Drowsiness Booster
|
13 Participants
|
13 Participants
|
18 Participants
|
12 Participants
|
17 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Drowsiness Booster
|
7 Participants
|
9 Participants
|
11 Participants
|
10 Participants
|
11 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Irritability Booster
|
15 Participants
|
17 Participants
|
26 Participants
|
17 Participants
|
19 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Irritability Booster
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Irritability Booster
|
9 Participants
|
11 Participants
|
15 Participants
|
13 Participants
|
13 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Loss of appetite Booster
|
6 Participants
|
10 Participants
|
13 Participants
|
15 Participants
|
8 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Loss of appetite Booster
|
4 Participants
|
4 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Any Fever Booster
|
8 Participants
|
10 Participants
|
10 Participants
|
5 Participants
|
7 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Grade 3 Fever Booster
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Related Fever Booster
|
5 Participants
|
3 Participants
|
7 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) follow-up period after each primary dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Outcome measures
| Measure |
Synflorix Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A Group
n=52 Participants
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
|
Synflorix/GSK 2189242A-LD Group
n=52 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
25 Participants
|
24 Participants
|
31 Participants
|
24 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Days 0-30) follow-up period after the booster dosePopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Outcome measures
| Measure |
Synflorix Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A Group
n=51 Participants
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
|
Synflorix/GSK 2189242A-LD Group
n=52 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=50 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
14 Participants
|
12 Participants
|
13 Participants
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: During the entire study period starting at the administration of the first vaccine dose up to study end (from Day 0 up to Month 7)Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Synflorix Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A Group
n=52 Participants
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
|
Synflorix/GSK 2189242A-LD Group
n=52 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=51 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
5 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Seropositivity status, defined as anti-pneumococcal dPly antibody concentrations ≥ 599 Luminex Units per milliliter (LU/mL) and anti-pneumococcal PhtD antibody concentrations ≥ 391 LU/mL.
Outcome measures
| Measure |
Synflorix Group
n=45 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A Group
n=45 Participants
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
|
Synflorix/GSK 2189242A-LD Group
n=47 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=41 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=41 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations
Anti-dPly, Post-dose 2
|
135703.5 LU/mL
Interval 95376.62 to 193081.3
|
148447.5 LU/mL
Interval 101599.9 to 216896.7
|
32436.07 LU/mL
Interval 25523.77 to 41220.35
|
57149.83 LU/mL
Interval 44908.69 to 72727.64
|
3759.82 LU/mL
Interval 2376.77 to 5947.68
|
|
Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations
Anti-dPly, Pre-booster
|
100811.4 LU/mL
Interval 74005.55 to 137326.8
|
96552.52 LU/mL
Interval 73753.5 to 126399.3
|
19573.55 LU/mL
Interval 14948.37 to 25629.82
|
29592.91 LU/mL
Interval 22065.25 to 39688.66
|
4654.16 LU/mL
Interval 2879.42 to 7522.78
|
|
Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations
Anti-dPly, Post-booster
|
224726.2 LU/mL
Interval 178187.6 to 283419.8
|
305912.3 LU/mL
Interval 248087.9 to 377214.4
|
44123.43 LU/mL
Interval 34299.98 to 56760.29
|
85805.02 LU/mL
Interval 67740.53 to 108686.8
|
4553.43 LU/mL
Interval 2878.04 to 7204.12
|
|
Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations
Anti-PhtD, Post-dose 2
|
30402.84 LU/mL
Interval 20723.61 to 44602.88
|
35043.91 LU/mL
Interval 24164.16 to 50822.19
|
23438.06 LU/mL
Interval 16617.86 to 33057.36
|
22141.18 LU/mL
Interval 15065.44 to 32540.15
|
3795.68 LU/mL
Interval 2268.23 to 6351.73
|
|
Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations
Anti-PhtD, Pre-booster
|
24350.58 LU/mL
Interval 17056.09 to 34764.74
|
23918.77 LU/mL
Interval 17724.59 to 32277.63
|
14375.59 LU/mL
Interval 9338.31 to 22130.1
|
12721.01 LU/mL
Interval 8498.0 to 19042.62
|
4814.97 LU/mL
Interval 2881.25 to 8046.46
|
|
Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations
Anti-PhtD, Post-booster
|
65584.24 LU/mL
Interval 50985.27 to 84363.43
|
77312.07 LU/mL
Interval 58589.49 to 102017.6
|
32609.19 LU/mL
Interval 23615.58 to 45027.88
|
36098.18 LU/mL
Interval 26620.97 to 48949.34
|
5072.43 LU/mL
Interval 3023.97 to 8508.53
|
SECONDARY outcome
Timeframe: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Seropositivity status, defined as anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotype 6A and 19 antibody concentrations ≥ 0.05 microgram per milliliter (µg/mL).
Outcome measures
| Measure |
Synflorix Group
n=43 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A Group
n=44 Participants
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
|
Synflorix/GSK 2189242A-LD Group
n=47 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=41 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=41 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-1, Pre-booster
|
0.05 µg/mL
Interval 0.03 to 0.06
|
0.05 µg/mL
Interval 0.04 to 0.07
|
0.87 µg/mL
Interval 0.68 to 1.12
|
0.75 µg/mL
Interval 0.57 to 0.99
|
0.73 µg/mL
Interval 0.55 to 0.97
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-5, Post-booster
|
0.07 µg/mL
Interval 0.05 to 0.09
|
0.07 µg/mL
Interval 0.05 to 0.09
|
3.57 µg/mL
Interval 2.79 to 4.57
|
3.45 µg/mL
Interval 2.7 to 4.41
|
3.84 µg/mL
Interval 2.98 to 4.95
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-6B, Post-Dose 2
|
0.04 µg/mL
Interval 0.03 to 0.05
|
0.03 µg/mL
Interval 0.02 to 0.03
|
0.55 µg/mL
Interval 0.37 to 0.81
|
0.48 µg/mL
Interval 0.32 to 0.72
|
0.55 µg/mL
Interval 0.39 to 0.78
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-7F, Post-booster
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.04 µg/mL
Interval 0.03 to 0.05
|
5.9 µg/mL
Interval 4.83 to 7.2
|
5.25 µg/mL
Interval 4.36 to 6.32
|
4.65 µg/mL
Interval 3.77 to 5.72
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-18C, Pre-booster
|
0.05 µg/mL
Interval 0.03 to 0.07
|
0.04 µg/mL
Interval 0.03 to 0.05
|
4.94 µg/mL
Interval 3.83 to 6.38
|
5.51 µg/mL
Interval 4.3 to 7.05
|
4.79 µg/mL
Interval 3.69 to 6.21
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-19F, Pre-booster
|
0.06 µg/mL
Interval 0.04 to 0.1
|
0.05 µg/mL
Interval 0.03 to 0.09
|
4.15 µg/mL
Interval 2.94 to 5.85
|
4.72 µg/mL
Interval 3.54 to 6.3
|
4.33 µg/mL
Interval 3.06 to 6.12
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-6A, Post-Dose 2
|
0.04 µg/mL
Interval 0.03 to 0.07
|
0.03 µg/mL
Interval 0.03 to 0.04
|
0.32 µg/mL
Interval 0.2 to 0.51
|
0.27 µg/mL
Interval 0.16 to 0.45
|
0.31 µg/mL
Interval 0.2 to 0.48
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-1, Post-Dose 2
|
0.04 µg/mL
Interval 0.03 to 0.05
|
0.05 µg/mL
Interval 0.04 to 0.06
|
2.5 µg/mL
Interval 2.01 to 3.11
|
2.08 µg/mL
Interval 1.56 to 2.77
|
2.13 µg/mL
Interval 1.62 to 2.79
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-1, Post-booster
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.05 µg/mL
Interval 0.04 to 0.08
|
2.69 µg/mL
Interval 2.13 to 3.39
|
2.47 µg/mL
Interval 2.03 to 3.0
|
2.4 µg/mL
Interval 1.85 to 3.12
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-4, Post-Dose 2
|
0.05 µg/mL
Interval 0.03 to 0.08
|
0.03 µg/mL
Interval 0.02 to 0.03
|
6.42 µg/mL
Interval 5.23 to 7.87
|
6.6 µg/mL
Interval 5.12 to 8.52
|
5.67 µg/mL
Interval 4.56 to 7.06
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-4, Pre-booster
|
0.05 µg/mL
Interval 0.03 to 0.07
|
0.03 µg/mL
Interval 0.03 to 0.03
|
2.3 µg/mL
Interval 1.82 to 2.91
|
2.36 µg/mL
Interval 1.79 to 3.11
|
2.11 µg/mL
Interval 1.68 to 2.64
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-4, Post-booster
|
0.05 µg/mL
Interval 0.03 to 0.07
|
0.04 µg/mL
Interval 0.03 to 0.05
|
5.26 µg/mL
Interval 4.14 to 6.69
|
5.61 µg/mL
Interval 4.46 to 7.07
|
5.18 µg/mL
Interval 4.05 to 6.63
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-5, Post-Dose 2
|
0.06 µg/mL
Interval 0.04 to 0.08
|
0.06 µg/mL
Interval 0.05 to 0.08
|
2.42 µg/mL
Interval 1.85 to 3.17
|
2.41 µg/mL
Interval 1.85 to 3.13
|
2.36 µg/mL
Interval 1.88 to 2.97
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-5, Pre-booster
|
0.07 µg/mL
Interval 0.05 to 0.1
|
0.06 µg/mL
Interval 0.05 to 0.08
|
1.08 µg/mL
Interval 0.83 to 1.41
|
1.05 µg/mL
Interval 0.81 to 1.36
|
1.18 µg/mL
Interval 0.94 to 1.48
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-6B, Pre-booster
|
0.04 µg/mL
Interval 0.03 to 0.05
|
0.04 µg/mL
Interval 0.03 to 0.05
|
0.39 µg/mL
Interval 0.28 to 0.54
|
0.42 µg/mL
Interval 0.3 to 0.59
|
0.46 µg/mL
Interval 0.34 to 0.62
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-6B, Post-booster
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.04 µg/mL
Interval 0.03 to 0.06
|
1.08 µg/mL
Interval 0.74 to 1.57
|
1.14 µg/mL
Interval 0.83 to 1.57
|
1.08 µg/mL
Interval 0.78 to 1.52
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-7F, Post-Dose 2
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.04 µg/mL
Interval 0.03 to 0.04
|
5.03 µg/mL
Interval 4.16 to 6.09
|
4.73 µg/mL
Interval 3.89 to 5.74
|
3.72 µg/mL
Interval 3.17 to 4.36
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-7F, Pre-booster
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.03 µg/mL
Interval 0.03 to 0.04
|
2.6 µg/mL
Interval 2.14 to 3.15
|
2.36 µg/mL
Interval 1.94 to 2.86
|
2.14 µg/mL
Interval 1.82 to 2.51
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-9V, Post-Dose 2
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.03 µg/mL
Interval 0.02 to 0.03
|
2.81 µg/mL
Interval 2.24 to 3.51
|
2.49 µg/mL
Interval 1.95 to 3.19
|
1.55 µg/mL
Interval 1.21 to 2.0
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-9V, Pre-booster
|
0.04 µg/mL
Interval 0.03 to 0.05
|
0.03 µg/mL
Interval 0.03 to 0.04
|
1.44 µg/mL
Interval 1.15 to 1.81
|
1.26 µg/mL
Interval 0.94 to 1.67
|
0.95 µg/mL
Interval 0.73 to 1.24
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-9V, Post-booster
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.03 µg/mL
Interval 0.02 to 0.04
|
3.13 µg/mL
Interval 2.48 to 3.93
|
3.21 µg/mL
Interval 2.45 to 4.19
|
2.18 µg/mL
Interval 1.71 to 2.79
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-14, Post-Dose 2
|
0.1 µg/mL
Interval 0.07 to 0.14
|
0.09 µg/mL
Interval 0.06 to 0.14
|
5.18 µg/mL
Interval 3.91 to 6.86
|
3.78 µg/mL
Interval 2.92 to 4.91
|
4.63 µg/mL
Interval 3.71 to 5.77
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-14, Pre-booster
|
0.11 µg/mL
Interval 0.08 to 0.17
|
0.11 µg/mL
Interval 0.07 to 0.18
|
2.86 µg/mL
Interval 2.25 to 3.65
|
2.3 µg/mL
Interval 1.81 to 2.91
|
2.71 µg/mL
Interval 2.17 to 3.38
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-14, Post-booster
|
0.13 µg/mL
Interval 0.09 to 0.18
|
0.16 µg/mL
Interval 0.1 to 0.26
|
7.74 µg/mL
Interval 6.03 to 9.94
|
6.62 µg/mL
Interval 5.22 to 8.4
|
5.98 µg/mL
Interval 4.68 to 7.63
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-18C, Post-Dose 2
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.04 µg/mL
Interval 0.03 to 0.05
|
13.92 µg/mL
Interval 10.75 to 18.03
|
16.92 µg/mL
Interval 13.61 to 21.03
|
12.56 µg/mL
Interval 9.8 to 16.1
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-18C, Post-booster
|
0.05 µg/mL
Interval 0.03 to 0.07
|
0.05 µg/mL
Interval 0.03 to 0.07
|
16.12 µg/mL
Interval 12.2 to 21.32
|
21.98 µg/mL
Interval 16.67 to 28.99
|
14.62 µg/mL
Interval 10.9 to 19.6
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-19F, Post-Dose 2
|
0.05 µg/mL
Interval 0.03 to 0.08
|
0.06 µg/mL
Interval 0.03 to 0.12
|
8.6 µg/mL
Interval 6.37 to 11.63
|
10.08 µg/mL
Interval 7.21 to 14.09
|
8.87 µg/mL
Interval 6.2 to 12.7
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-19F, Post-booster
|
0.06 µg/mL
Interval 0.04 to 0.09
|
0.07 µg/mL
Interval 0.04 to 0.13
|
10.46 µg/mL
Interval 7.35 to 14.88
|
14.38 µg/mL
Interval 10.53 to 19.63
|
11.32 µg/mL
Interval 7.94 to 16.13
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-23F, Post-Dose 2
|
0.03 µg/mL
Interval 0.03 to 0.04
|
0.04 µg/mL
Interval 0.03 to 0.05
|
1.19 µg/mL
Interval 0.82 to 1.74
|
0.91 µg/mL
Interval 0.62 to 1.33
|
0.73 µg/mL
Interval 0.54 to 0.98
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-23F, Pre-booster
|
0.03 µg/mL
Interval 0.03 to 0.04
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.71 µg/mL
Interval 0.5 to 0.99
|
0.62 µg/mL
Interval 0.45 to 0.85
|
0.51 µg/mL
Interval 0.39 to 0.67
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-23F, Post-booster
|
0.03 µg/mL
Interval 0.03 to 0.04
|
0.05 µg/mL
Interval 0.03 to 0.06
|
1.92 µg/mL
Interval 1.42 to 2.6
|
2.04 µg/mL
Interval 1.56 to 2.65
|
1.47 µg/mL
Interval 1.04 to 2.06
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-6A, Pre-booster
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.04 µg/mL
Interval 0.03 to 0.04
|
0.24 µg/mL
Interval 0.17 to 0.34
|
0.24 µg/mL
Interval 0.15 to 0.38
|
0.27 µg/mL
Interval 0.18 to 0.4
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-6A, Post-booster
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.04 µg/mL
Interval 0.03 to 0.06
|
0.53 µg/mL
Interval 0.35 to 0.79
|
0.56 µg/mL
Interval 0.36 to 0.87
|
0.58 µg/mL
Interval 0.37 to 0.9
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-19A, Post-Dose 2
|
0.07 µg/mL
Interval 0.04 to 0.12
|
0.05 µg/mL
Interval 0.03 to 0.06
|
1.08 µg/mL
Interval 0.71 to 1.62
|
0.97 µg/mL
Interval 0.63 to 1.48
|
0.93 µg/mL
Interval 0.61 to 1.43
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-19A, Pre-booster
|
0.07 µg/mL
Interval 0.04 to 0.1
|
0.05 µg/mL
Interval 0.04 to 0.06
|
0.85 µg/mL
Interval 0.61 to 1.17
|
0.68 µg/mL
Interval 0.47 to 0.98
|
0.62 µg/mL
Interval 0.42 to 0.93
|
|
Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Anti-19A, Post-booster
|
0.07 µg/mL
Interval 0.05 to 0.11
|
0.05 µg/mL
Interval 0.04 to 0.07
|
2.76 µg/mL
Interval 1.92 to 3.96
|
2.98 µg/mL
Interval 2.08 to 4.26
|
2.06 µg/mL
Interval 1.3 to 3.25
|
SECONDARY outcome
Timeframe: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Seropositivity status, defined as Opsonophagocytic activity against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and cross-reactive serotypes 6A and 19A ≥ 8.
Outcome measures
| Measure |
Synflorix Group
n=35 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A Group
n=36 Participants
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
|
Synflorix/GSK 2189242A-LD Group
n=37 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=36 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=37 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-4, Pre-booster
|
12.6 Titers
Interval 5.6 to 28.4
|
16.2 Titers
Interval 7.0 to 37.2
|
247.9 Titers
Interval 117.4 to 523.2
|
259.9 Titers
Interval 120.6 to 560.0
|
478.9 Titers
Interval 309.3 to 741.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-4, Post-booster
|
15.5 Titers
Interval 6.1 to 39.5
|
17.8 Titers
Interval 7.3 to 43.4
|
1206.2 Titers
Interval 888.9 to 1636.8
|
1385 Titers
Interval 974.5 to 1968.4
|
1476 Titers
Interval 1076.0 to 2024.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-5, Post-Dose 2
|
4 Titers
Interval 4.0 to 4.0
|
4.7 Titers
Interval 3.4 to 6.5
|
43.8 Titers
Interval 27.1 to 70.8
|
37.3 Titers
Interval 21.7 to 64.0
|
42 Titers
Interval 26.6 to 66.4
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-5, Pre-booster
|
4.5 Titers
Interval 3.5 to 5.8
|
4 Titers
Interval 4.0 to 4.0
|
12.8 Titers
Interval 8.2 to 19.9
|
14.8 Titers
Interval 9.6 to 23.0
|
17 Titers
Interval 10.9 to 26.4
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-5, Post-booster
|
4 Titers
Interval 4.0 to 4.0
|
5.1 Titers
Interval 3.8 to 6.7
|
99.3 Titers
Interval 62.1 to 158.8
|
110.4 Titers
Interval 73.1 to 166.8
|
160.7 Titers
Interval 113.0 to 228.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-6B, Post-Dose 2
|
15 Titers
Interval 4.2 to 53.1
|
23.4 Titers
Interval 6.1 to 90.3
|
361.9 Titers
Interval 120.0 to 1091.7
|
527.5 Titers
Interval 202.6 to 1372.9
|
915.3 Titers
Interval 543.4 to 1541.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-6A, Post-booster
|
11.8 Titers
Interval 4.7 to 29.5
|
17.3 Titers
Interval 7.9 to 37.9
|
308 Titers
Interval 141.0 to 672.9
|
348.2 Titers
Interval 154.9 to 782.5
|
554.3 Titers
Interval 248.3 to 1237.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-19A, Post-Dose 2
|
5.8 Titers
Interval 3.4 to 9.9
|
4.6 Titers
Interval 3.7 to 5.6
|
246 Titers
Interval 109.7 to 551.7
|
363.2 Titers
Interval 202.1 to 652.8
|
349.9 Titers
Interval 177.1 to 691.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-19A, Pre-booster
|
6 Titers
Interval 4.0 to 9.1
|
4.5 Titers
Interval 3.8 to 5.3
|
56.7 Titers
Interval 25.2 to 127.9
|
76.4 Titers
Interval 36.3 to 160.7
|
87.8 Titers
Interval 40.6 to 189.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-19A, Post-booster
|
6.7 Titers
Interval 4.3 to 10.3
|
6.3 Titers
Interval 4.4 to 9.1
|
746.3 Titers
Interval 407.8 to 1365.6
|
989.3 Titers
Interval 652.5 to 1500.0
|
725.9 Titers
Interval 367.8 to 1432.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-4, Post-Dose 2
|
7 Titers
Interval 3.1 to 15.6
|
8.9 Titers
Interval 4.5 to 17.6
|
1260.2 Titers
Interval 856.1 to 1855.2
|
1197.9 Titers
Interval 784.1 to 1830.2
|
1220.4 Titers
Interval 913.8 to 1629.9
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-7F, Post-Dose 2
|
734.6 Titers
Interval 369.7 to 1459.6
|
807.4 Titers
Interval 445.0 to 1465.2
|
5703.7 Titers
Interval 4143.6 to 7851.2
|
4936.6 Titers
Interval 3320.7 to 7338.7
|
6154.4 Titers
Interval 4244.4 to 8923.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-19F, Pre-booster
|
5 Titers
Interval 3.1 to 8.2
|
8 Titers
Interval 4.3 to 14.7
|
794.3 Titers
Interval 476.6 to 1324.0
|
420.7 Titers
Interval 197.4 to 896.4
|
625.4 Titers
Interval 266.5 to 1467.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-6B, Pre-booster
|
56.7 Titers
Interval 16.2 to 198.4
|
61.6 Titers
Interval 19.2 to 197.3
|
213.8 Titers
Interval 79.0 to 578.1
|
513.1 Titers
Interval 243.9 to 1079.6
|
371.9 Titers
Interval 172.5 to 801.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-6B, Post-booster
|
26.1 Titers
Interval 7.7 to 88.7
|
30.8 Titers
Interval 11.2 to 84.7
|
804.6 Titers
Interval 343.5 to 1884.9
|
982.7 Titers
Interval 527.6 to 1830.4
|
1523.1 Titers
Interval 875.8 to 2649.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-1, Pre-booster
|
4 Titers
Interval 4.0 to 4.0
|
4.3 Titers
Interval 3.7 to 5.0
|
23 Titers
Interval 13.1 to 40.3
|
12.4 Titers
Interval 7.6 to 20.3
|
19.3 Titers
Interval 11.1 to 33.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-1, Post-booster
|
5.2 Titers
Interval 4.0 to 6.9
|
8.1 Titers
Interval 4.8 to 13.7
|
169.5 Titers
Interval 96.1 to 298.8
|
200 Titers
Interval 138.2 to 289.4
|
206.9 Titers
Interval 123.1 to 347.5
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-7F, Pre-booster
|
670.4 Titers
Interval 317.5 to 1415.6
|
462.3 Titers
Interval 187.5 to 1139.8
|
2450.1 Titers
Interval 1637.4 to 3666.2
|
2713.5 Titers
Interval 1836.1 to 4010.1
|
3844.5 Titers
Interval 2725.7 to 5422.4
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-7F, Post-booster
|
936.8 Titers
Interval 510.0 to 1720.7
|
785.5 Titers
Interval 428.0 to 1441.6
|
4109.3 Titers
Interval 3086.9 to 5470.3
|
5730.4 Titers
Interval 4262.0 to 7704.7
|
7404.7 Titers
Interval 5271.1 to 10401.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-9V, Post-Dose 2
|
26.5 Titers
Interval 8.2 to 85.9
|
50.1 Titers
Interval 17.5 to 143.7
|
4455 Titers
Interval 2803.3 to 7079.9
|
3542.8 Titers
Interval 2271.5 to 5525.5
|
3947.2 Titers
Interval 2612.7 to 5963.5
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-9V, Pre-booster
|
172.4 Titers
Interval 68.9 to 431.4
|
172 Titers
Interval 57.6 to 513.2
|
2126.1 Titers
Interval 1140.2 to 3964.4
|
2622.4 Titers
Interval 1786.7 to 3849.0
|
3450 Titers
Interval 2357.5 to 5048.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-9V, Post-booster
|
173.5 Titers
Interval 59.1 to 509.8
|
137.6 Titers
Interval 51.7 to 366.0
|
4643.1 Titers
Interval 3418.3 to 6306.9
|
5802.4 Titers
Interval 4453.0 to 7560.8
|
6016.6 Titers
Interval 4617.2 to 7840.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-14, Post-Dose 2
|
21.1 Titers
Interval 6.7 to 66.8
|
11.9 Titers
Interval 4.7 to 30.4
|
3324.8 Titers
Interval 2324.8 to 4754.8
|
2580.7 Titers
Interval 1788.4 to 3724.0
|
2487.6 Titers
Interval 1703.4 to 3632.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-14, Pre-booster
|
21 Titers
Interval 8.5 to 51.6
|
27.9 Titers
Interval 10.4 to 75.1
|
1390.5 Titers
Interval 615.7 to 3140.4
|
1725.8 Titers
Interval 972.1 to 3064.0
|
1776.6 Titers
Interval 1009.5 to 3126.5
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-14, Post-booster
|
32.3 Titers
Interval 11.5 to 90.9
|
46.7 Titers
Interval 17.0 to 127.8
|
2911.6 Titers
Interval 1841.3 to 4604.0
|
3729.8 Titers
Interval 2693.2 to 5165.4
|
3094 Titers
Interval 2353.3 to 4068.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-18C, Post-Dose 2
|
4 Titers
Interval 4.0 to 4.0
|
7.4 Titers
Interval 3.7 to 15.1
|
1398.3 Titers
Interval 810.6 to 2412.0
|
2538.4 Titers
Interval 1787.3 to 3605.0
|
1905.4 Titers
Interval 1271.4 to 2855.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-18C, Pre-booster
|
5.4 Titers
Interval 3.4 to 8.3
|
5 Titers
Interval 3.7 to 6.8
|
420.1 Titers
Interval 192.8 to 915.3
|
1041 Titers
Interval 699.6 to 1548.9
|
766.4 Titers
Interval 468.4 to 1253.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-18C, Post-booster
|
6 Titers
Interval 3.3 to 10.7
|
8 Titers
Interval 4.4 to 14.6
|
1764.6 Titers
Interval 1243.6 to 2503.8
|
2640.6 Titers
Interval 2083.3 to 3346.8
|
2123.4 Titers
Interval 1493.0 to 3020.1
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-19F, Post-booster
|
4.9 Titers
Interval 3.5 to 6.8
|
4.4 Titers
Interval 3.7 to 5.2
|
173.3 Titers
Interval 86.1 to 349.0
|
210.1 Titers
Interval 118.4 to 373.0
|
260.7 Titers
Interval 138.0 to 492.5
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-19F, Post-Dose 2
|
5.6 Titers
Interval 3.4 to 9.1
|
7.3 Titers
Interval 4.3 to 12.6
|
1248.5 Titers
Interval 740.4 to 2105.3
|
1823.7 Titers
Interval 1252.9 to 2654.5
|
1625.3 Titers
Interval 931.7 to 2835.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-23F, Post-Dose 2
|
17.9 Titers
Interval 5.1 to 62.9
|
107.8 Titers
Interval 28.1 to 412.8
|
1735.5 Titers
Interval 833.6 to 3613.3
|
3621.8 Titers
Interval 2431.4 to 5395.2
|
2502.5 Titers
Interval 1610.5 to 3888.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-23F, Pre-booster
|
23.2 Titers
Interval 7.6 to 70.3
|
136.3 Titers
Interval 36.1 to 514.6
|
989.7 Titers
Interval 419.2 to 2336.8
|
1635.9 Titers
Interval 691.7 to 3868.8
|
897.4 Titers
Interval 381.6 to 2110.4
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-23F, Post-booster
|
68.6 Titers
Interval 17.3 to 271.2
|
106.7 Titers
Interval 28.5 to 399.4
|
3598.5 Titers
Interval 2422.2 to 5345.9
|
6108 Titers
Interval 4335.9 to 8604.5
|
5296.1 Titers
Interval 3857.9 to 7270.4
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-6A, Post-Dose 2
|
9.3 Titers
Interval 3.5 to 24.7
|
5.7 Titers
Interval 3.4 to 9.5
|
225.3 Titers
Interval 83.3 to 608.8
|
186.2 Titers
Interval 55.3 to 627.2
|
364.5 Titers
Interval 158.7 to 837.1
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-6A, Pre-booster
|
18.4 Titers
Interval 7.6 to 44.5
|
9.4 Titers
Interval 4.5 to 19.5
|
58.9 Titers
Interval 21.6 to 160.3
|
99.4 Titers
Interval 39.9 to 247.8
|
221.7 Titers
Interval 93.8 to 524.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
OPSONO-1, Post-Dose 2
|
4 Titers
Interval 4.0 to 4.0
|
5.4 Titers
Interval 3.8 to 7.8
|
71.8 Titers
Interval 40.9 to 126.1
|
48.2 Titers
Interval 26.5 to 87.6
|
90 Titers
Interval 52.9 to 153.0
|
SECONDARY outcome
Timeframe: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL).
Outcome measures
| Measure |
Synflorix Group
n=45 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A Group
n=45 Participants
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
|
Synflorix/GSK 2189242A-LD Group
n=47 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=41 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=41 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Antibody Concentrations to Protein D (Anti-PD)
Anti-PD, Post-Dose 2
|
90.9 LU/mL
Interval 71.1 to 116.3
|
100.4 LU/mL
Interval 76.3 to 132.1
|
1105.4 LU/mL
Interval 833.7 to 1465.7
|
600.2 LU/mL
Interval 426.5 to 844.7
|
860 LU/mL
Interval 659.2 to 1121.9
|
|
Antibody Concentrations to Protein D (Anti-PD)
Anti-PD, Pre-booster
|
89.1 LU/mL
Interval 71.8 to 110.7
|
118.2 LU/mL
Interval 89.6 to 155.9
|
734.6 LU/mL
Interval 523.9 to 1030.1
|
463 LU/mL
Interval 330.2 to 649.3
|
691.8 LU/mL
Interval 527.6 to 907.1
|
|
Antibody Concentrations to Protein D (Anti-PD)
Anti-PD, Post-booster
|
97.9 LU/mL
Interval 78.0 to 122.9
|
130.6 LU/mL
Interval 93.1 to 183.3
|
1882.6 LU/mL
Interval 1407.4 to 2518.1
|
1474.6 LU/mL
Interval 1103.7 to 1970.3
|
1963.8 LU/mL
Interval 1560.1 to 2472.0
|
SECONDARY outcome
Timeframe: One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Inhibition of haemolysis activity of pneumolysin (Ply) by anti-dPly antibodies was measured in vitro by mean of a haemolytic assay. The haemolysis activity could be followed by measuring the level of haemoglobin released. Anti-dPly titers (for inhibition of haemolytic activity) ≥ 140.
Outcome measures
| Measure |
Synflorix Group
n=43 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A Group
n=38 Participants
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
|
Synflorix/GSK 2189242A-LD Group
n=43 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=39 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=40 Participants
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity
Anti-Hem-dPly, Post-booster
|
4332.4 Titers
Interval 3327.6 to 5640.4
|
5931.9 Titers
Interval 4744.5 to 7416.4
|
1346.2 Titers
Interval 1068.2 to 1696.5
|
2388.3 Titers
Interval 1830.6 to 3115.9
|
818.6 Titers
Interval 662.5 to 1011.5
|
|
Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity
Anti-Hem-dPly, Post-Dose 2
|
3080 Titers
Interval 2555.3 to 3712.5
|
2988.7 Titers
Interval 2410.1 to 3706.2
|
1278.9 Titers
Interval 1048.2 to 1560.3
|
1814 Titers
Interval 1495.3 to 2200.8
|
913.2 Titers
Interval 699.1 to 1192.8
|
|
Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity
Anti-Hem-dPly, Pre-booster
|
2441.1 Titers
Interval 1867.1 to 3191.7
|
2193.7 Titers
Interval 1737.3 to 2770.0
|
1141.5 Titers
Interval 950.6 to 1370.6
|
1344.2 Titers
Interval 1087.6 to 1661.3
|
995.9 Titers
Interval 788.3 to 1258.2
|
Adverse Events
GSK 2189242A-LD Group
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
GSK 2189242A-HD Group
Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths
Synflorix/GSK 2189242A-LD Group
Serious events: 5 serious events
Other events: 49 other events
Deaths: 0 deaths
Synflorix/GSK 2189242A-HD Group
Serious events: 0 serious events
Other events: 49 other events
Deaths: 0 deaths
Synflorix Group
Serious events: 4 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK 2189242A-LD Group
n=51 participants at risk
Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
GSK 2189242A-HD Group
n=52 participants at risk
Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-LD Group
n=52 participants at risk
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=51 participants at risk
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=51 participants at risk
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Vascular disorders
Haematoma
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Injury, poisoning and procedural complications
Accidental exposure
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Injury, poisoning and procedural complications
Foreign body
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Pyrexia
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Psychiatric disorders
Affective disorder
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Gastroenteritis salmonella
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Bronchitis
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Laryngitis
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Oral herpes
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Pharyngo-tonsillitis
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Viral infection
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
Other adverse events
| Measure |
GSK 2189242A-LD Group
n=51 participants at risk
Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
GSK 2189242A-HD Group
n=52 participants at risk
Subjects received 2 primary vaccination doses of GSK Biologicals' candidate pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-LD Group
n=52 participants at risk
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, Low Dose (LD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix/GSK 2189242A-HD Group
n=51 participants at risk
Subjects received 2 primary vaccination doses of Synflorix™ vaccine combined with the pneumococcal protein vaccine (GSK 2189242A) containing the pneumococcal proteins dPly and PhtD, High Dose (HD) vaccine formulation, at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
Synflorix Group
n=51 participants at risk
Subjects received 2 primary vaccination doses of Synflorix™ vaccine at Month 0 and Month 2 and a booster dose at Month 6. The vaccine was administered intramuscularly, into the deltoid muscle or into the anterolateral thigh (if the deltoid muscle size was not adequate).
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.8%
6/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
5.8%
3/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
3.8%
2/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
7.8%
4/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
5.8%
3/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Pain Primary
|
52.9%
27/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
53.8%
28/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
65.4%
34/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
64.7%
33/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
66.7%
34/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Redness Primary
|
47.1%
24/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
57.7%
30/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
69.2%
36/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
64.7%
33/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
58.8%
30/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Swelling Primary
|
33.3%
17/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
21.2%
11/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
48.1%
25/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
41.2%
21/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
51.0%
26/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Pain Booster
|
35.3%
18/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
42.3%
22/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
61.5%
32/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
51.0%
26/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
49.0%
25/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Redness Booster
|
37.3%
19/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
38.5%
20/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
53.8%
28/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
43.1%
22/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
41.2%
21/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Swelling Booster
|
21.6%
11/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
15.4%
8/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
34.6%
18/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
29.4%
15/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
25.5%
13/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Drowsiness Primary
|
49.0%
25/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
40.4%
21/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
65.4%
34/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
54.9%
28/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
68.6%
35/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Irritability Primary
|
51.0%
26/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
44.2%
23/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
67.3%
35/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
70.6%
36/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
68.6%
35/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Loss of appetite Primary
|
37.3%
19/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
28.8%
15/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
38.5%
20/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
37.3%
19/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
45.1%
23/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Temperature/Rectally Primary
|
25.5%
13/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
30.8%
16/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
34.6%
18/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
35.3%
18/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
33.3%
17/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Drowsiness Booster
|
25.5%
13/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
25.0%
13/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
34.6%
18/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
23.5%
12/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
33.3%
17/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Irritability Booster
|
29.4%
15/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
32.7%
17/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
50.0%
26/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
33.3%
17/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
37.3%
19/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Loss of appetite Booster
|
11.8%
6/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
19.2%
10/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
25.0%
13/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
29.4%
15/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
15.7%
8/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
General disorders
Temperature/Rectally Booster
|
15.7%
8/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
19.2%
10/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
19.2%
10/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
9.8%
5/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
13.7%
7/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Nasopharyngitis Primary
|
7.8%
4/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
15.4%
8/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
17.3%
9/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
7.8%
4/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
13.7%
7/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Nasopharyngitis Booster
|
5.9%
3/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
5.8%
3/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
3.8%
2/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
3.9%
2/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Rhinitis Primary
|
5.9%
3/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
7.7%
4/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Rhinitis Booster
|
7.8%
4/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
5.8%
3/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
7.7%
4/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
7.8%
4/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
5.9%
3/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Gastroenteritis
|
3.9%
2/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
3.8%
2/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
5.8%
3/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Viral infection
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
7.7%
4/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
5.9%
3/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
2.0%
1/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Laryngitis
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
7.8%
4/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
3.9%
2/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
|
Infections and infestations
Varicella
|
0.00%
0/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
1.9%
1/52 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
5.9%
3/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
3.9%
2/51 • Solicited local and general symptoms: during the 7-day (Days 0-6) post-primary and post-booster vaccination period; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination period; SAEs: during the whole study period (from Day 0 up to Month 7).
|
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