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Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

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ClinicalTrials.gov Identifier: NCT00985751
Recruitment Status : Completed
First Posted : September 28, 2009
Results First Posted : October 6, 2017
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition Infections, Streptococcal
Interventions Biological: Pneumococcal vaccine GSK2189242A (formulation 1)
Biological: Pneumococcal vaccine GSK2189242A (formulation 2)
Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)
Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)
Biological: Pneumococcal vaccine GSK1024850A
Enrollment 257
Recruitment Details  
Pre-assignment Details During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Hide Arm/Group Description 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). 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). 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). 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). 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).
Period Title: Overall Study
Started 51 52 52 51 51
Completed 51 52 52 51 50
Not Completed 0 0 0 0 1
Reason Not Completed
Adverse Event             0             0             0             0             1
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group Total
Hide Arm/Group Description 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). 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). 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). 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). 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 of all reporting groups
Overall Number of Baseline Participants 51 52 52 51 51 257
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants 257 participants
17  (3.6) 16.7  (3.81) 17.1  (4.03) 16.8  (3.96) 16.3  (4.18) 16.78  (3.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants 257 participants
Female
25
  49.0%
22
  42.3%
23
  44.2%
29
  56.9%
28
  54.9%
127
  49.4%
Male
26
  51.0%
30
  57.7%
29
  55.8%
22
  43.1%
23
  45.1%
130
  50.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants 257 participants
White-Caucasian/European heritage
51
 100.0%
52
 100.0%
51
  98.1%
51
 100.0%
49
  96.1%
254
  98.8%
White-Arabic/North African heritage
0
   0.0%
0
   0.0%
1
   1.9%
0
   0.0%
2
   3.9%
3
   1.2%
1.Primary Outcome
Title Number of Subjects With Fever > 40.0°C (Rectal Temperature)
Hide Description The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported.
Time Frame Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title Synflorix Group Synflorix/GSK 2189242A Group
Hide Arm/Group Description:
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).
This group included subjects from Synflorix/GSK 2189242A-LD and Synflorix/GSK 2189242A-HD groups for whom pooled analysis was conducted.
Overall Number of Participants Analyzed 51 103
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   1.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synflorix Group, Synflorix/GSK 2189242A Group
Comments

Fever >40°C-non-inferiority:

To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine (GSK 2189242A) combined with Synflorix™ vaccine (pooled groups) versus Synflorix™ vaccine (Synflorix/GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever > 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% CI for the difference between groups in the percentage of subjects with rectal temperature > 40.0°C within the 7-day follow-up period following primary vaccination was computed for the Synflorix/GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature >40.0°C would be detected if the 95% CIs included 0 and non-inferiority would
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
-6.1 to 5.32
Estimation Comments [Not Specified]
2.Primary Outcome
Title Number of Subjects With Fever > 40.0°C (Rectal Temperature)
Hide Description The number of subjects with rectal temperature higher (>) than 40.0 degrees Celsius (°C) is reported.
Time Frame Within 7 days (Day 0-Day 6) following at least one dose of the primary vaccination
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title Synflorix Group GSK 2189242A Group
Hide Arm/Group Description:
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).
This group included subjects from GSK 2189242A-LD and GSK 2189242A-HD groups for whom pooled analysis was conducted.
Overall Number of Participants Analyzed 51 103
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   1.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Synflorix Group, GSK 2189242A Group
Comments

Fever >40°C-non-inferiority:

To compare the 2 formulations of GSK Biologicals' S. pneumoniae protein containing vaccine GSK 2189242A (pooled groups) versus Synflorix™ vaccine (GSK 2189242A Group minus Synflorix Group) with respect to the percentage of subjects reporting fever > 40.0°C (rectal temperature) within 7 days after at least 1 dose of primary vaccination.

Type of Statistical Test Non-Inferiority or Equivalence
Comments The 95% CI for the difference between groups in the percentage of subjects with rectal temperature > 40.0°C within the 7-day follow-up period following primary vaccination was computed for the GSK 2189242A Group minus Synflorix Group. No statistically significant difference between groups in rectal temperature >40.0°C would be detected if the 95% CIs included 0 and non-inferiority would be express
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
-6.1 to 5.32
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Hide Description 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.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2 and Booster dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Hide Arm/Group Description:
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).
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).
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).
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).
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 Number of Participants Analyzed 51 52 52 51 51
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
18
  35.3%
15
  28.8%
31
  59.6%
23
  45.1%
26
  51.0%
Grade 3 Pain Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
0
   0.0%
0
   0.0%
1
   1.9%
2
   3.9%
4
   7.8%
Any Redness Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
17
  33.3%
20
  38.5%
32
  61.5%
28
  54.9%
25
  49.0%
Grade 3 Redness Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
1
   2.0%
0
   0.0%
5
   9.6%
4
   7.8%
2
   3.9%
Any Swelling Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
8
  15.7%
5
   9.6%
19
  36.5%
17
  33.3%
19
  37.3%
Grade 3 Swelling Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
0
   0.0%
0
   0.0%
2
   3.8%
2
   3.9%
1
   2.0%
Any Pain Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
15
  29.4%
22
  42.3%
24
  46.2%
27
  52.9%
27
  54.0%
Grade 3 Pain Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
0
   0.0%
0
   0.0%
2
   3.8%
2
   3.9%
3
   6.0%
Any Redness Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
21
  41.2%
25
  48.1%
23
  44.2%
22
  43.1%
24
  48.0%
Grade 3 Redness Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
1
   2.0%
1
   1.9%
4
   7.7%
1
   2.0%
3
   6.0%
Any Swelling Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
11
  21.6%
9
  17.3%
18
  34.6%
11
  21.6%
16
  32.0%
Grade 3 Swelling Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
0
   0.0%
0
   0.0%
5
   9.6%
1
   2.0%
2
   4.0%
Any Pain Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
18
  35.3%
22
  43.1%
32
  61.5%
26
  51.0%
25
  50.0%
Grade 3 Pain Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
0
   0.0%
0
   0.0%
3
   5.8%
2
   3.9%
1
   2.0%
Any Redness Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
19
  37.3%
20
  39.2%
28
  53.8%
22
  43.1%
21
  42.0%
Grade 3 Redness Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
2
   3.9%
2
   3.9%
5
   9.6%
4
   7.8%
3
   6.0%
Any Swelling Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
11
  21.6%
8
  15.7%
18
  34.6%
15
  29.4%
13
  26.0%
Grade 3 Swelling Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
0
   0.0%
3
   5.9%
3
   5.8%
1
   2.0%
3
   6.0%
4.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Hide Description 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.
Time Frame During the 7-day (Days 0-6) post-vaccination period following each dose (Dose 1, Dose 2, Booster dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Hide Arm/Group Description:
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).
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).
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).
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).
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 Number of Participants Analyzed 51 52 52 51 51
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
16
  31.4%
13
  25.0%
24
  46.2%
20
  39.2%
26
  51.0%
Grade 3 Drowsiness Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Drowsiness Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
6
  11.8%
6
  11.5%
13
  25.0%
10
  19.6%
16
  31.4%
Any Irritability Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
21
  41.2%
16
  30.8%
31
  59.6%
27
  52.9%
23
  45.1%
Grade 3 Irritability Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Irritability Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
6
  11.8%
9
  17.3%
17
  32.7%
16
  31.4%
14
  27.5%
Any Loss of appetite Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
15
  29.4%
7
  13.5%
14
  26.9%
12
  23.5%
14
  27.5%
Grade 3 Loss of appetite Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
2
   3.9%
0
   0.0%
1
   1.9%
0
   0.0%
0
   0.0%
Related Loss of appetite Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
4
   7.8%
5
   9.6%
9
  17.3%
3
   5.9%
7
  13.7%
Any Fever Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
7
  13.7%
8
  15.4%
14
  26.9%
12
  23.5%
12
  23.5%
Grade 3 Fever Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
0
   0.0%
1
   1.9%
1
   1.9%
0
   0.0%
0
   0.0%
Related Fever Dose 1 Number Analyzed 51 participants 52 participants 52 participants 51 participants 51 participants
3
   5.9%
2
   3.8%
7
  13.5%
8
  15.7%
9
  17.6%
Any Drowsiness Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
12
  23.5%
16
  30.8%
17
  32.7%
15
  29.4%
23
  46.0%
Grade 3 Drowsiness Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Drowsiness Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
6
  11.8%
11
  21.2%
11
  21.2%
10
  19.6%
18
  36.0%
Any Irritability Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
12
  23.5%
18
  34.6%
22
  42.3%
24
  47.1%
27
  54.0%
Grade 3 Irritability Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
Related Irritability Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
3
   5.9%
11
  21.2%
17
  32.7%
18
  35.3%
21
  42.0%
Any Loss of appetite Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
8
  15.7%
10
  19.2%
12
  23.1%
9
  17.6%
13
  26.0%
Grade 3 Loss of appetite Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Loss of appetite Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
4
   7.8%
5
   9.6%
9
  17.3%
5
   9.8%
7
  14.0%
Any Fever Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
9
  17.6%
12
  23.1%
8
  15.4%
9
  17.6%
7
  14.0%
Grade 3 Fever Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Fever Dose 2 Number Analyzed 51 participants 52 participants 52 participants 51 participants 50 participants
2
   3.9%
6
  11.5%
5
   9.6%
7
  13.7%
7
  14.0%
Any Drowsiness Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
13
  25.5%
13
  25.5%
18
  34.6%
12
  23.5%
17
  34.0%
Grade 3 Drowsiness Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Drowsiness Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
7
  13.7%
9
  17.6%
11
  21.2%
10
  19.6%
11
  22.0%
Any Irritability Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
15
  29.4%
17
  33.3%
26
  50.0%
17
  33.3%
19
  38.0%
Grade 3 Irritability Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
1
   2.0%
Related Irritability Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
9
  17.6%
11
  21.6%
15
  28.8%
13
  25.5%
13
  26.0%
Any Loss of appetite Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
6
  11.8%
10
  19.6%
13
  25.0%
15
  29.4%
8
  16.0%
Grade 3 Loss of appetite Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
2
   3.9%
0
   0.0%
1
   1.9%
1
   2.0%
1
   2.0%
Related Loss of appetite Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
4
   7.8%
4
   7.8%
7
  13.5%
7
  13.7%
6
  12.0%
Any Fever Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
8
  15.7%
10
  19.6%
10
  19.2%
5
   9.8%
7
  14.0%
Grade 3 Fever Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Fever Booster Number Analyzed 51 participants 51 participants 52 participants 51 participants 50 participants
5
   9.8%
3
   5.9%
7
  13.5%
2
   3.9%
3
   6.0%
5.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description 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.
Time Frame During the 31-day (Days 0-30) follow-up period after each primary dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Hide Arm/Group Description:
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).
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).
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).
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).
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 Number of Participants Analyzed 51 52 52 51 51
Measure Type: Count of Participants
Unit of Measure: Participants
25
  49.0%
24
  46.2%
31
  59.6%
24
  47.1%
22
  43.1%
6.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description 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.
Time Frame During the 31-day (Days 0-30) follow-up period after the booster dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented and with the symptom sheet filled in.
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Hide Arm/Group Description:
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).
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).
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).
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).
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 Number of Participants Analyzed 51 51 52 51 50
Measure Type: Count of Participants
Unit of Measure: Participants
14
  27.5%
12
  23.5%
13
  25.0%
4
   7.8%
9
  18.0%
7.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Hide Arm/Group Description:
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).
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).
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).
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).
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 Number of Participants Analyzed 51 52 52 51 51
Measure Type: Count of Participants
Unit of Measure: Participants
5
   9.8%
3
   5.8%
5
   9.6%
0
   0.0%
4
   7.8%
8.Secondary Outcome
Title Anti-pneumococcal dPly and PhtD Proteins Antibody Concentrations
Hide Description 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.
Time Frame One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Hide Arm/Group Description:
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).
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).
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).
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).
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 Number of Participants Analyzed 45 45 47 41 41
Geometric Mean (95% Confidence Interval)
Unit of Measure: LU/mL
Anti-dPly, Post-dose 2 Number Analyzed 45 participants 43 participants 45 participants 39 participants 41 participants
135703.5
(95376.62 to 193081.3)
148447.5
(101599.9 to 216896.7)
32436.07
(25523.77 to 41220.35)
57149.83
(44908.69 to 72727.64)
3759.82
(2376.77 to 5947.68)
Anti-dPly, Pre-booster Number Analyzed 44 participants 45 participants 46 participants 40 participants 40 participants
100811.4
(74005.55 to 137326.8)
96552.52
(73753.5 to 126399.3)
19573.55
(14948.37 to 25629.82)
29592.91
(22065.25 to 39688.66)
4654.16
(2879.42 to 7522.78)
Anti-dPly, Post-booster Number Analyzed 44 participants 43 participants 47 participants 41 participants 41 participants
224726.2
(178187.6 to 283419.8)
305912.3
(248087.9 to 377214.4)
44123.43
(34299.98 to 56760.29)
85805.02
(67740.53 to 108686.8)
4553.43
(2878.04 to 7204.12)
Anti-PhtD, Post-dose 2 Number Analyzed 45 participants 43 participants 45 participants 39 participants 41 participants
30402.84
(20723.61 to 44602.88)
35043.91
(24164.16 to 50822.19)
23438.06
(16617.86 to 33057.36)
22141.18
(15065.44 to 32540.15)
3795.68
(2268.23 to 6351.73)
Anti-PhtD, Pre-booster Number Analyzed 44 participants 45 participants 46 participants 40 participants 40 participants
24350.58
(17056.09 to 34764.74)
23918.77
(17724.59 to 32277.63)
14375.59
(9338.31 to 22130.1)
12721.01
(8498 to 19042.62)
4814.97
(2881.25 to 8046.46)
Anti-PhtD, Post-booster Number Analyzed 44 participants 43 participants 47 participants 41 participants 41 participants
65584.24
(50985.27 to 84363.43)
77312.07
(58589.49 to 102017.6)
32609.19
(23615.58 to 45027.88)
36098.18
(26620.97 to 48949.34)
5072.43
(3023.97 to 8508.53)
9.Secondary Outcome
Title Anti-pneumococcal Serotypes and Cross-reactive Serotypes Antibody Concentrations
Hide Description 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).
Time Frame One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Hide Arm/Group Description:
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).
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).
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).
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).
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 Number of Participants Analyzed 43 44 47 41 41
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Anti-1, Post-Dose 2 Number Analyzed 40 participants 36 participants 46 participants 40 participants 41 participants
0.04
(0.03 to 0.05)
0.05
(0.04 to 0.06)
2.5
(2.01 to 3.11)
2.08
(1.56 to 2.77)
2.13
(1.62 to 2.79)
Anti-1, Pre-booster Number Analyzed 43 participants 42 participants 45 participants 40 participants 40 participants
0.05
(0.03 to 0.06)
0.05
(0.04 to 0.07)
0.87
(0.68 to 1.12)
0.75
(0.57 to 0.99)
0.73
(0.55 to 0.97)
Anti-1, Post-booster Number Analyzed 40 participants 41 participants 47 participants 41 participants 41 participants
0.04
(0.03 to 0.06)
0.05
(0.04 to 0.08)
2.69
(2.13 to 3.39)
2.47
(2.03 to 3)
2.4
(1.85 to 3.12)
Anti-4, Post-Dose 2 Number Analyzed 37 participants 37 participants 46 participants 40 participants 41 participants
0.05
(0.03 to 0.08)
0.03
(0.02 to 0.03)
6.42
(5.23 to 7.87)
6.6
(5.12 to 8.52)
5.67
(4.56 to 7.06)
Anti-4, Pre-booster Number Analyzed 41 participants 41 participants 46 participants 41 participants 40 participants
0.05
(0.03 to 0.07)
0.03
(0.03 to 0.03)
2.3
(1.82 to 2.91)
2.36
(1.79 to 3.11)
2.11
(1.68 to 2.64)
Anti-4, Post-booster Number Analyzed 40 participants 41 participants 47 participants 41 participants 41 participants
0.05
(0.03 to 0.07)
0.04
(0.03 to 0.05)
5.26
(4.14 to 6.69)
5.61
(4.46 to 7.07)
5.18
(4.05 to 6.63)
Anti-5, Post-Dose 2 Number Analyzed 31 participants 34 participants 44 participants 39 participants 41 participants
0.06
(0.04 to 0.08)
0.06
(0.05 to 0.08)
2.42
(1.85 to 3.17)
2.41
(1.85 to 3.13)
2.36
(1.88 to 2.97)
Anti-5, Pre-booster Number Analyzed 42 participants 43 participants 45 participants 41 participants 40 participants
0.07
(0.05 to 0.1)
0.06
(0.05 to 0.08)
1.08
(0.83 to 1.41)
1.05
(0.81 to 1.36)
1.18
(0.94 to 1.48)
Anti-5, Post-booster Number Analyzed 41 participants 43 participants 47 participants 41 participants 41 participants
0.07
(0.05 to 0.09)
0.07
(0.05 to 0.09)
3.57
(2.79 to 4.57)
3.45
(2.7 to 4.41)
3.84
(2.98 to 4.95)
Anti-6B, Post-Dose 2 Number Analyzed 43 participants 39 participants 46 participants 40 participants 41 participants
0.04
(0.03 to 0.05)
0.03
(0.02 to 0.03)
0.55
(0.37 to 0.81)
0.48
(0.32 to 0.72)
0.55
(0.39 to 0.78)
Anti-6B, Pre-booster Number Analyzed 42 participants 41 participants 44 participants 40 participants 40 participants
0.04
(0.03 to 0.05)
0.04
(0.03 to 0.05)
0.39
(0.28 to 0.54)
0.42
(0.3 to 0.59)
0.46
(0.34 to 0.62)
Anti-6B, Post-booster Number Analyzed 41 participants 42 participants 47 participants 41 participants 40 participants
0.04
(0.03 to 0.06)
0.04
(0.03 to 0.06)
1.08
(0.74 to 1.57)
1.14
(0.83 to 1.57)
1.08
(0.78 to 1.52)
Anti-7F, Post-Dose 2 Number Analyzed 37 participants 38 participants 46 participants 40 participants 41 participants
0.04
(0.03 to 0.06)
0.04
(0.03 to 0.04)
5.03
(4.16 to 6.09)
4.73
(3.89 to 5.74)
3.72
(3.17 to 4.36)
Anti-7F, Pre-booster Number Analyzed 42 participants 44 participants 46 participants 41 participants 40 participants
0.04
(0.03 to 0.06)
0.03
(0.03 to 0.04)
2.6
(2.14 to 3.15)
2.36
(1.94 to 2.86)
2.14
(1.82 to 2.51)
Anti-7F, Post-booster Number Analyzed 41 participants 43 participants 47 participants 41 participants 41 participants
0.04
(0.03 to 0.06)
0.04
(0.03 to 0.05)
5.9
(4.83 to 7.2)
5.25
(4.36 to 6.32)
4.65
(3.77 to 5.72)
Anti-9V, Post-Dose 2 Number Analyzed 42 participants 40 participants 46 participants 40 participants 41 participants
0.04
(0.03 to 0.06)
0.03
(0.02 to 0.03)
2.81
(2.24 to 3.51)
2.49
(1.95 to 3.19)
1.55
(1.21 to 2)
Anti-9V, Pre-booster Number Analyzed 41 participants 42 participants 45 participants 41 participants 40 participants
0.04
(0.03 to 0.05)
0.03
(0.03 to 0.04)
1.44
(1.15 to 1.81)
1.26
(0.94 to 1.67)
0.95
(0.73 to 1.24)
Anti-9V, Post-booster Number Analyzed 39 participants 40 participants 47 participants 41 participants 40 participants
0.04
(0.03 to 0.06)
0.03
(0.02 to 0.04)
3.13
(2.48 to 3.93)
3.21
(2.45 to 4.19)
2.18
(1.71 to 2.79)
Anti-14, Post-Dose 2 Number Analyzed 43 participants 36 participants 46 participants 40 participants 41 participants
0.1
(0.07 to 0.14)
0.09
(0.06 to 0.14)
5.18
(3.91 to 6.86)
3.78
(2.92 to 4.91)
4.63
(3.71 to 5.77)
Anti-14, Pre-booster Number Analyzed 40 participants 40 participants 46 participants 40 participants 40 participants
0.11
(0.08 to 0.17)
0.11
(0.07 to 0.18)
2.86
(2.25 to 3.65)
2.3
(1.81 to 2.91)
2.71
(2.17 to 3.38)
Anti-14, Post-booster Number Analyzed 42 participants 43 participants 47 participants 41 participants 41 participants
0.13
(0.09 to 0.18)
0.16
(0.1 to 0.26)
7.74
(6.03 to 9.94)
6.62
(5.22 to 8.4)
5.98
(4.68 to 7.63)
Anti-18C, Post-Dose 2 Number Analyzed 39 participants 39 participants 45 participants 40 participants 41 participants
0.04
(0.03 to 0.06)
0.04
(0.03 to 0.05)
13.92
(10.75 to 18.03)
16.92
(13.61 to 21.03)
12.56
(9.8 to 16.1)
Anti-18C, Pre-booster Number Analyzed 41 participants 42 participants 45 participants 41 participants 40 participants
0.05
(0.03 to 0.07)
0.04
(0.03 to 0.05)
4.94
(3.83 to 6.38)
5.51
(4.3 to 7.05)
4.79
(3.69 to 6.21)
Anti-18C, Post-booster Number Analyzed 42 participants 44 participants 47 participants 41 participants 40 participants
0.05
(0.03 to 0.07)
0.05
(0.03 to 0.07)
16.12
(12.2 to 21.32)
21.98
(16.67 to 28.99)
14.62
(10.9 to 19.6)
Anti-19F, Post-Dose 2 Number Analyzed 33 participants 35 participants 45 participants 39 participants 41 participants
0.05
(0.03 to 0.08)
0.06
(0.03 to 0.12)
8.6
(6.37 to 11.63)
10.08
(7.21 to 14.09)
8.87
(6.2 to 12.7)
Anti-19F, Pre-booster Number Analyzed 38 participants 40 participants 46 participants 41 participants 40 participants
0.06
(0.04 to 0.1)
0.05
(0.03 to 0.09)
4.15
(2.94 to 5.85)
4.72
(3.54 to 6.3)
4.33
(3.06 to 6.12)
Anti-19F, Post-booster Number Analyzed 41 participants 40 participants 47 participants 41 participants 41 participants
0.06
(0.04 to 0.09)
0.07
(0.04 to 0.13)
10.46
(7.35 to 14.88)
14.38
(10.53 to 19.63)
11.32
(7.94 to 16.13)
Anti-23F, Post-Dose 2 Number Analyzed 38 participants 38 participants 45 participants 39 participants 41 participants
0.03
(0.03 to 0.04)
0.04
(0.03 to 0.05)
1.19
(0.82 to 1.74)
0.91
(0.62 to 1.33)
0.73
(0.54 to 0.98)
Anti-23F, Pre-booster Number Analyzed 42 participants 41 participants 45 participants 41 participants 40 participants
0.03
(0.03 to 0.04)
0.04
(0.03 to 0.06)
0.71
(0.5 to 0.99)
0.62
(0.45 to 0.85)
0.51
(0.39 to 0.67)
Anti-23F, Post-booster Number Analyzed 41 participants 43 participants 47 participants 41 participants 40 participants
0.03
(0.03 to 0.04)
0.05
(0.03 to 0.06)
1.92
(1.42 to 2.6)
2.04
(1.56 to 2.65)
1.47
(1.04 to 2.06)
Anti-6A, Post-Dose 2 Number Analyzed 33 participants 37 participants 43 participants 40 participants 41 participants
0.04
(0.03 to 0.07)
0.03
(0.03 to 0.04)
0.32
(0.2 to 0.51)
0.27
(0.16 to 0.45)
0.31
(0.2 to 0.48)
Anti-6A, Pre-booster Number Analyzed 42 participants 42 participants 44 participants 41 participants 40 participants
0.04
(0.03 to 0.06)
0.04
(0.03 to 0.04)
0.24
(0.17 to 0.34)
0.24
(0.15 to 0.38)
0.27
(0.18 to 0.4)
Anti-6A, Post-booster Number Analyzed 42 participants 40 participants 47 participants 41 participants 40 participants
0.04
(0.03 to 0.06)
0.04
(0.03 to 0.06)
0.53
(0.35 to 0.79)
0.56
(0.36 to 0.87)
0.58
(0.37 to 0.9)
Anti-19A, Post-Dose 2 Number Analyzed 33 participants 35 participants 43 participants 39 participants 41 participants
0.07
(0.04 to 0.12)
0.05
(0.03 to 0.06)
1.08
(0.71 to 1.62)
0.97
(0.63 to 1.48)
0.93
(0.61 to 1.43)
Anti-19A, Pre-booster Number Analyzed 43 participants 42 participants 44 participants 41 participants 40 participants
0.07
(0.04 to 0.1)
0.05
(0.04 to 0.06)
0.85
(0.61 to 1.17)
0.68
(0.47 to 0.98)
0.62
(0.42 to 0.93)
Anti-19A, Post-booster Number Analyzed 41 participants 39 participants 47 participants 41 participants 41 participants
0.07
(0.05 to 0.11)
0.05
(0.04 to 0.07)
2.76
(1.92 to 3.96)
2.98
(2.08 to 4.26)
2.06
(1.3 to 3.25)
10.Secondary Outcome
Title Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes and Cross-reactive Serotypes
Hide Description 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.
Time Frame One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Hide Arm/Group Description:
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).
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).
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).
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).
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 Number of Participants Analyzed 35 36 37 36 37
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
OPSONO-1, Post-Dose 2 Number Analyzed 27 participants 33 participants 35 participants 30 participants 30 participants
4
(4 to 4)
5.4
(3.8 to 7.8)
71.8
(40.9 to 126.1)
48.2
(26.5 to 87.6)
90
(52.9 to 153)
OPSONO-1, Pre-booster Number Analyzed 35 participants 35 participants 33 participants 35 participants 34 participants
4
(4 to 4)
4.3
(3.7 to 5)
23
(13.1 to 40.3)
12.4
(7.6 to 20.3)
19.3
(11.1 to 33.6)
OPSONO-1, Post-booster Number Analyzed 31 participants 35 participants 37 participants 36 participants 37 participants
5.2
(4 to 6.9)
8.1
(4.8 to 13.7)
169.5
(96.1 to 298.8)
200
(138.2 to 289.4)
206.9
(123.1 to 347.5)
OPSONO-4, Post-Dose 2 Number Analyzed 20 participants 29 participants 32 participants 29 participants 29 participants
7
(3.1 to 15.6)
8.9
(4.5 to 17.6)
1260.2
(856.1 to 1855.2)
1197.9
(784.1 to 1830.2)
1220.4
(913.8 to 1629.9)
OPSONO-4, Pre-booster Number Analyzed 28 participants 29 participants 29 participants 33 participants 30 participants
12.6
(5.6 to 28.4)
16.2
(7 to 37.2)
247.9
(117.4 to 523.2)
259.9
(120.6 to 560)
478.9
(309.3 to 741.3)
OPSONO-4, Post-booster Number Analyzed 24 participants 31 participants 35 participants 32 participants 34 participants
15.5
(6.1 to 39.5)
17.8
(7.3 to 43.4)
1206.2
(888.9 to 1636.8)
1385
(974.5 to 1968.4)
1476
(1076 to 2024.6)
OPSONO-5, Post-Dose 2 Number Analyzed 27 participants 33 participants 33 participants 30 participants 31 participants
4
(4 to 4)
4.7
(3.4 to 6.5)
43.8
(27.1 to 70.8)
37.3
(21.7 to 64)
42
(26.6 to 66.4)
OPSONO-5, Pre-booster Number Analyzed 34 participants 35 participants 34 participants 33 participants 34 participants
4.5
(3.5 to 5.8)
4
(4 to 4)
12.8
(8.2 to 19.9)
14.8
(9.6 to 23)
17
(10.9 to 26.4)
OPSONO-5, Post-booster Number Analyzed 30 participants 36 participants 37 participants 34 participants 36 participants
4
(4 to 4)
5.1
(3.8 to 6.7)
99.3
(62.1 to 158.8)
110.4
(73.1 to 166.8)
160.7
(113 to 228.7)
OPSONO-6B, Post-Dose 2 Number Analyzed 16 participants 21 participants 27 participants 25 participants 28 participants
15
(4.2 to 53.1)
23.4
(6.1 to 90.3)
361.9
(120 to 1091.7)
527.5
(202.6 to 1372.9)
915.3
(543.4 to 1541.8)
OPSONO-6B, Pre-booster Number Analyzed 23 participants 27 participants 30 participants 30 participants 30 participants
56.7
(16.2 to 198.4)
61.6
(19.2 to 197.3)
213.8
(79 to 578.1)
513.1
(243.9 to 1079.6)
371.9
(172.5 to 801.8)
OPSONO-6B, Post-booster Number Analyzed 24 participants 33 participants 33 participants 34 participants 35 participants
26.1
(7.7 to 88.7)
30.8
(11.2 to 84.7)
804.6
(343.5 to 1884.9)
982.7
(527.6 to 1830.4)
1523.1
(875.8 to 2649)
OPSONO-7F, Post-Dose 2 Number Analyzed 27 participants 33 participants 33 participants 29 participants 30 participants
734.6
(369.7 to 1459.6)
807.4
(445 to 1465.2)
5703.7
(4143.6 to 7851.2)
4936.6
(3320.7 to 7338.7)
6154.4
(4244.4 to 8923.7)
OPSONO-7F, Pre-booster Number Analyzed 33 participants 30 participants 32 participants 34 participants 33 participants
670.4
(317.5 to 1415.6)
462.3
(187.5 to 1139.8)
2450.1
(1637.4 to 3666.2)
2713.5
(1836.1 to 4010.1)
3844.5
(2725.7 to 5422.4)
OPSONO-7F, Post-booster Number Analyzed 30 participants 35 participants 35 participants 33 participants 36 participants
936.8
(510 to 1720.7)
785.5
(428 to 1441.6)
4109.3
(3086.9 to 5470.3)
5730.4
(4262 to 7704.7)
7404.7
(5271.1 to 10401.8)
OPSONO-9V, Post-Dose 2 Number Analyzed 22 participants 29 participants 34 participants 29 participants 30 participants
26.5
(8.2 to 85.9)
50.1
(17.5 to 143.7)
4455
(2803.3 to 7079.9)
3542.8
(2271.5 to 5525.5)
3947.2
(2612.7 to 5963.5)
OPSONO-9V, Pre-booster Number Analyzed 30 participants 28 participants 32 participants 33 participants 32 participants
172.4
(68.9 to 431.4)
172
(57.6 to 513.2)
2126.1
(1140.2 to 3964.4)
2622.4
(1786.7 to 3849)
3450
(2357.5 to 5048.7)
OPSONO-9V, Post-booster Number Analyzed 26 participants 32 participants 37 participants 34 participants 36 participants
173.5
(59.1 to 509.8)
137.6
(51.7 to 366)
4643.1
(3418.3 to 6306.9)
5802.4
(4453 to 7560.8)
6016.6
(4617.2 to 7840)
OPSONO-14, Post-Dose 2 Number Analyzed 18 participants 23 participants 33 participants 29 participants 31 participants
21.1
(6.7 to 66.8)
11.9
(4.7 to 30.4)
3324.8
(2324.8 to 4754.8)
2580.7
(1788.4 to 3724)
2487.6
(1703.4 to 3632.7)
OPSONO-14, Pre-booster Number Analyzed 30 participants 30 participants 32 participants 34 participants 33 participants
21
(8.5 to 51.6)
27.9
(10.4 to 75.1)
1390.5
(615.7 to 3140.4)
1725.8
(972.1 to 3064)
1776.6
(1009.5 to 3126.5)
OPSONO-14, Post-booster Number Analyzed 27 participants 33 participants 34 participants 36 participants 37 participants
32.3
(11.5 to 90.9)
46.7
(17 to 127.8)
2911.6
(1841.3 to 4604)
3729.8
(2693.2 to 5165.4)
3094
(2353.3 to 4068)
OPSONO-18C, Post-Dose 2 Number Analyzed 24 participants 29 participants 33 participants 28 participants 27 participants
4
(4 to 4)
7.4
(3.7 to 15.1)
1398.3
(810.6 to 2412)
2538.4
(1787.3 to 3605)
1905.4
(1271.4 to 2855.6)
OPSONO-18C, Pre-booster Number Analyzed 33 participants 33 participants 31 participants 34 participants 34 participants
5.4
(3.4 to 8.3)
5
(3.7 to 6.8)
420.1
(192.8 to 915.3)
1041
(699.6 to 1548.9)
766.4
(468.4 to 1253.8)
OPSONO-18C, Post-booster Number Analyzed 26 participants 32 participants 34 participants 32 participants 33 participants
6
(3.3 to 10.7)
8
(4.4 to 14.6)
1764.6
(1243.6 to 2503.8)
2640.6
(2083.3 to 3346.8)
2123.4
(1493 to 3020.1)
OPSONO-19F, Pre-booster Number Analyzed 31 participants 34 participants 30 participants 34 participants 34 participants
5
(3.1 to 8.2)
8
(4.3 to 14.7)
794.3
(476.6 to 1324)
420.7
(197.4 to 896.4)
625.4
(266.5 to 1467.7)
OPSONO-19F, Post-booster Number Analyzed 30 participants 36 participants 36 participants 34 participants 34 participants
4.9
(3.5 to 6.8)
4.4
(3.7 to 5.2)
173.3
(86.1 to 349)
210.1
(118.4 to 373)
260.7
(138 to 492.5)
OPSONO-19F, Post-Dose 2 Number Analyzed 17 participants 28 participants 32 participants 28 participants 27 participants
5.6
(3.4 to 9.1)
7.3
(4.3 to 12.6)
1248.5
(740.4 to 2105.3)
1823.7
(1252.9 to 2654.5)
1625.3
(931.7 to 2835.3)
OPSONO-23F, Post-Dose 2 Number Analyzed 20 participants 28 participants 34 participants 28 participants 29 participants
17.9
(5.1 to 62.9)
107.8
(28.1 to 412.8)
1735.5
(833.6 to 3613.3)
3621.8
(2431.4 to 5395.2)
2502.5
(1610.5 to 3888.6)
OPSONO-23F, Pre-booster Number Analyzed 30 participants 33 participants 32 participants 33 participants 33 participants
23.2
(7.6 to 70.3)
136.3
(36.1 to 514.6)
989.7
(419.2 to 2336.8)
1635.9
(691.7 to 3868.8)
897.4
(381.6 to 2110.4)
OPSONO-23F, Post-booster Number Analyzed 25 participants 33 participants 35 participants 35 participants 36 participants
68.6
(17.3 to 271.2)
106.7
(28.5 to 399.4)
3598.5
(2422.2 to 5345.9)
6108
(4335.9 to 8604.5)
5296.1
(3857.9 to 7270.4)
OPSONO-6A, Post-Dose 2 Number Analyzed 19 participants 26 participants 31 participants 21 participants 27 participants
9.3
(3.5 to 24.7)
5.7
(3.4 to 9.5)
225.3
(83.3 to 608.8)
186.2
(55.3 to 627.2)
364.5
(158.7 to 837.1)
OPSONO-6A, Pre-booster Number Analyzed 27 participants 30 participants 31 participants 33 participants 32 participants
18.4
(7.6 to 44.5)
9.4
(4.5 to 19.5)
58.9
(21.6 to 160.3)
99.4
(39.9 to 247.8)
221.7
(93.8 to 524)
OPSONO-6A, Post-booster Number Analyzed 22 participants 32 participants 34 participants 31 participants 32 participants
11.8
(4.7 to 29.5)
17.3
(7.9 to 37.9)
308
(141 to 672.9)
348.2
(154.9 to 782.5)
554.3
(248.3 to 1237.6)
OPSONO-19A, Post-Dose 2 Number Analyzed 25 participants 31 participants 34 participants 28 participants 29 participants
5.8
(3.4 to 9.9)
4.6
(3.7 to 5.6)
246
(109.7 to 551.7)
363.2
(202.1 to 652.8)
349.9
(177.1 to 691.6)
OPSONO-19A, Pre-booster Number Analyzed 35 participants 35 participants 33 participants 35 participants 32 participants
6
(4 to 9.1)
4.5
(3.8 to 5.3)
56.7
(25.2 to 127.9)
76.4
(36.3 to 160.7)
87.8
(40.6 to 189.7)
OPSONO-19A, Post-booster Number Analyzed 30 participants 36 participants 34 participants 34 participants 34 participants
6.7
(4.3 to 10.3)
6.3
(4.4 to 9.1)
746.3
(407.8 to 1365.6)
989.3
(652.5 to 1500)
725.9
(367.8 to 1432.6)
11.Secondary Outcome
Title Antibody Concentrations to Protein D (Anti-PD)
Hide Description Seropositivity status, defined as anti-PD antibody concentrations ≥ 112 Luminex Units per milliliter (LU/mL).
Time Frame One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Hide Arm/Group Description:
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).
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).
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).
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).
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 Number of Participants Analyzed 45 45 47 41 41
Geometric Mean (95% Confidence Interval)
Unit of Measure: LU/mL
Anti-PD, Post-Dose 2 Number Analyzed 45 participants 43 participants 45 participants 39 participants 41 participants
90.9
(71.1 to 116.3)
100.4
(76.3 to 132.1)
1105.4
(833.7 to 1465.7)
600.2
(426.5 to 844.7)
860
(659.2 to 1121.9)
Anti-PD, Pre-booster Number Analyzed 44 participants 45 participants 46 participants 40 participants 40 participants
89.1
(71.8 to 110.7)
118.2
(89.6 to 155.9)
734.6
(523.9 to 1030.1)
463
(330.2 to 649.3)
691.8
(527.6 to 907.1)
Anti-PD, Post-booster Number Analyzed 44 participants 43 participants 47 participants 41 participants 41 participants
97.9
(78 to 122.9)
130.6
(93.1 to 183.3)
1882.6
(1407.4 to 2518.1)
1474.6
(1103.7 to 1970.3)
1963.8
(1560.1 to 2472)
12.Secondary Outcome
Title Level of Anti-dPly Antibodies Inhibiting Ply Haemolysis Activity
Hide Description 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.
Time Frame One month post-dose 2 (Month 3), prior to the booster dose (Month 6) and one month post-booster (Month 7)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Hide Arm/Group Description:
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).
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).
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).
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).
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 Number of Participants Analyzed 43 38 43 39 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Hem-dPly, Post-Dose 2 Number Analyzed 43 participants 38 participants 43 participants 39 participants 40 participants
3080
(2555.3 to 3712.5)
2988.7
(2410.1 to 3706.2)
1278.9
(1048.2 to 1560.3)
1814
(1495.3 to 2200.8)
913.2
(699.1 to 1192.8)
Anti-Hem-dPly, Pre-booster Number Analyzed 37 participants 37 participants 37 participants 34 participants 35 participants
2441.1
(1867.1 to 3191.7)
2193.7
(1737.3 to 2770)
1141.5
(950.6 to 1370.6)
1344.2
(1087.6 to 1661.3)
995.9
(788.3 to 1258.2)
Anti-Hem-dPly, Post-booster Number Analyzed 31 participants 32 participants 36 participants 32 participants 30 participants
4332.4
(3327.6 to 5640.4)
5931.9
(4744.5 to 7416.4)
1346.2
(1068.2 to 1696.5)
2388.3
(1830.6 to 3115.9)
818.6
(662.5 to 1011.5)
Time Frame 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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Hide Arm/Group Description 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). 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). 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). 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). 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).
All-Cause Mortality
GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/51 (0.00%)   0/52 (0.00%)   0/52 (0.00%)   0/51 (0.00%)   0/51 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/51 (9.80%)   3/52 (5.77%)   5/52 (9.62%)   0/51 (0.00%)   4/51 (7.84%) 
Ear and labyrinth disorders           
Ear haemorrhage  1  0/51 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/51 (0.00%)  0/51 (0.00%) 
Gastrointestinal disorders           
Enterocolitis  1  0/51 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/51 (0.00%)  0/51 (0.00%) 
General disorders           
Pyrexia  1  0/51 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/51 (1.96%) 
Infections and infestations           
Gastroenteritis salmonella  1  1/51 (1.96%)  0/52 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/51 (1.96%) 
Bronchitis  1  1/51 (1.96%)  0/52 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  0/51 (0.00%) 
Bronchopneumonia  1  0/51 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/51 (0.00%) 
Gastroenteritis  1  0/51 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/51 (1.96%) 
Laryngitis  1  1/51 (1.96%)  0/52 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  0/51 (0.00%) 
Oral herpes  1  0/51 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/51 (0.00%)  0/51 (0.00%) 
Pharyngo-tonsillitis  1  0/51 (0.00%)  1/52 (1.92%)  0/52 (0.00%)  0/51 (0.00%)  0/51 (0.00%) 
Viral infection  1  0/51 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/51 (0.00%) 
Injury, poisoning and procedural complications           
Concussion  1  0/51 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  1/51 (1.96%) 
Accidental exposure  1  0/51 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/51 (0.00%) 
Foreign body  1  1/51 (1.96%)  0/52 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  0/51 (0.00%) 
Open wound  1  0/51 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/51 (1.96%) 
Metabolism and nutrition disorders           
Type 1 diabetes mellitus  1  0/51 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/51 (0.00%) 
Nervous system disorders           
Febrile convulsion  1  0/51 (0.00%)  0/52 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  1/51 (1.96%) 
Psychiatric disorders           
Affective disorder  1  1/51 (1.96%)  0/52 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  0/51 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Adenoidal hypertrophy  1  0/51 (0.00%)  0/52 (0.00%)  1/52 (1.92%)  0/51 (0.00%)  0/51 (0.00%) 
Vascular disorders           
Haematoma  1  1/51 (1.96%)  0/52 (0.00%)  0/52 (0.00%)  0/51 (0.00%)  0/51 (0.00%) 
1
Term from vocabulary, MedDRA 14.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK 2189242A-LD Group GSK 2189242A-HD Group Synflorix/GSK 2189242A-LD Group Synflorix/GSK 2189242A-HD Group Synflorix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   27/51 (52.94%)   30/52 (57.69%)   36/52 (69.23%)   36/51 (70.59%)   35/51 (68.63%) 
Eye disorders           
Conjunctivitis  1  0/51 (0.00%)  0/52 (0.00%)  3/52 (5.77%)  0/51 (0.00%)  0/51 (0.00%) 
General disorders           
Pain Primary  1  27/51 (52.94%)  28/52 (53.85%)  34/52 (65.38%)  33/51 (64.71%)  34/51 (66.67%) 
Redness Primary  1  24/51 (47.06%)  30/52 (57.69%)  36/52 (69.23%)  33/51 (64.71%)  30/51 (58.82%) 
Swelling Primary  1  17/51 (33.33%)  11/52 (21.15%)  25/52 (48.08%)  21/51 (41.18%)  26/51 (50.98%) 
Pain Booster  1  18/51 (35.29%)  22/52 (42.31%)  32/52 (61.54%)  26/51 (50.98%)  25/51 (49.02%) 
Redness Booster  1  19/51 (37.25%)  20/52 (38.46%)  28/52 (53.85%)  22/51 (43.14%)  21/51 (41.18%) 
Swelling Booster  1  11/51 (21.57%)  8/52 (15.38%)  18/52 (34.62%)  15/51 (29.41%)  13/51 (25.49%) 
Drowsiness Primary  1  25/51 (49.02%)  21/52 (40.38%)  34/52 (65.38%)  28/51 (54.90%)  35/51 (68.63%) 
Irritability Primary  1  26/51 (50.98%)  23/52 (44.23%)  35/52 (67.31%)  36/51 (70.59%)  35/51 (68.63%) 
Loss of appetite Primary  1  19/51 (37.25%)  15/52 (28.85%)  20/52 (38.46%)  19/51 (37.25%)  23/51 (45.10%) 
Temperature/Rectally Primary  1  13/51 (25.49%)  16/52 (30.77%)  18/52 (34.62%)  18/51 (35.29%)  17/51 (33.33%) 
Drowsiness Booster  1  13/51 (25.49%)  13/52 (25.00%)  18/52 (34.62%)  12/51 (23.53%)  17/51 (33.33%) 
Irritability Booster  1  15/51 (29.41%)  17/52 (32.69%)  26/52 (50.00%)  17/51 (33.33%)  19/51 (37.25%) 
Loss of appetite Booster  1  6/51 (11.76%)  10/52 (19.23%)  13/52 (25.00%)  15/51 (29.41%)  8/51 (15.69%) 
Temperature/Rectally Booster  1  8/51 (15.69%)  10/52 (19.23%)  10/52 (19.23%)  5/51 (9.80%)  7/51 (13.73%) 
Infections and infestations           
Nasopharyngitis Primary  1  4/51 (7.84%)  8/52 (15.38%)  9/52 (17.31%)  4/51 (7.84%)  7/51 (13.73%) 
Nasopharyngitis Booster  1  3/51 (5.88%)  3/52 (5.77%)  2/52 (3.85%)  0/51 (0.00%)  2/51 (3.92%) 
Rhinitis Primary  1  3/51 (5.88%)  1/52 (1.92%)  4/52 (7.69%)  1/51 (1.96%)  1/51 (1.96%) 
Rhinitis Booster  1  4/51 (7.84%)  1/52 (1.92%)  1/52 (1.92%)  1/51 (1.96%)  0/51 (0.00%) 
Bronchitis  1  0/51 (0.00%)  3/52 (5.77%)  4/52 (7.69%)  4/51 (7.84%)  3/51 (5.88%) 
Gastroenteritis  1  2/51 (3.92%)  2/52 (3.85%)  3/52 (5.77%)  0/51 (0.00%)  1/51 (1.96%) 
Viral infection  1  1/51 (1.96%)  1/52 (1.92%)  4/52 (7.69%)  3/51 (5.88%)  1/51 (1.96%) 
Laryngitis  1  0/51 (0.00%)  1/52 (1.92%)  1/52 (1.92%)  4/51 (7.84%)  2/51 (3.92%) 
Varicella  1  0/51 (0.00%)  1/52 (1.92%)  1/52 (1.92%)  3/51 (5.88%)  2/51 (3.92%) 
Respiratory, thoracic and mediastinal disorders           
Cough  1  6/51 (11.76%)  3/52 (5.77%)  2/52 (3.85%)  1/51 (1.96%)  4/51 (7.84%) 
1
Term from vocabulary, MedDRA 14.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00985751     History of Changes
Other Study ID Numbers: 113171
First Submitted: September 24, 2009
First Posted: September 28, 2009
Results First Submitted: May 11, 2017
Results First Posted: October 6, 2017
Last Update Posted: October 6, 2017