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Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

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ClinicalTrials.gov Identifier: NCT01106092
Recruitment Status : Completed
First Posted : April 19, 2010
Results First Posted : April 12, 2017
Last Update Posted : June 6, 2018
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
Conditions Haemophilus Influenzae Type b
Tetanus
Hepatitis B
Whole Cell Pertussis
Diphtheria
Interventions Biological: GSK2036874A vaccine
Biological: Zilbrix™/Hib vaccine
Biological: Poliorix™
Enrollment 312
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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0. Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0. Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0. Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Period Title: Overall Study
Started 78 78 78 78
Completed 78 78 78 77
Not Completed 0 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             1
Arm/Group Title GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group Total
Hide Arm/Group Description Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0. Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0. Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0. Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively. Total of all reporting groups
Overall Number of Baseline Participants 78 78 78 78 312
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 78 participants 78 participants 78 participants 78 participants 312 participants
17.4  (3.81) 18  (2.96) 17.7  (3.38) 17.5  (3.59) 17.65  (3.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 78 participants 78 participants 78 participants 312 participants
Female
37
  47.4%
31
  39.7%
35
  44.9%
40
  51.3%
143
  45.8%
Male
41
  52.6%
47
  60.3%
43
  55.1%
38
  48.7%
169
  54.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian-South East Asian heritage Number Analyzed 78 participants 78 participants 78 participants 78 participants 312 participants
78
 100.0%
78
 100.0%
78
 100.0%
78
 100.0%
312
 100.0%
1.Primary Outcome
Title Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Hide Description Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.
Time Frame One month after booster vaccination (At Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.
Arm/Group Title GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 77
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-polio 1 Number Analyzed 78 participants 78 participants 78 participants 77 participants
78
 100.0%
77
  98.7%
78
 100.0%
77
 100.0%
Anti-polio 2 Number Analyzed 77 participants 78 participants 78 participants 77 participants
77
 100.0%
78
 100.0%
78
 100.0%
77
 100.0%
Anti-polio 3 Number Analyzed 78 participants 78 participants 78 participants 77 participants
77
  98.7%
77
  98.7%
78
 100.0%
77
 100.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK2036874A Group 1, Zilbrix/Hib/Poliorix Group
Comments To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix™/Hib vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: The upper limit (UL) of the standardized asymptotic 95% confidence interval (CI) on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1] difference in percentage of seroprotected subjects ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 0
Confidence Interval (2-Sided) 95%
-4.78 to 4.72
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection GSK2036874A Group 2, Zilbrix/Hib/Poliorix Group
Comments To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2] difference in percentage of seroprotected subjects ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
-3.53 to 6.94
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection GSK2036874A Group 3, Zilbrix/Hib/Poliorix Group
Comments To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 1 antibodies, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3] difference in percentage of seroprotected subjects ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 0
Confidence Interval (2-Sided) 95%
-4.78 to 4.72
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection GSK2036874A Group 1, Zilbrix/Hib/Poliorix Group
Comments To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1] difference in percentage of seroprotected subjects ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 0
Confidence Interval (2-Sided) 95%
-4.78 to 4.78
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection GSK2036874A Group 2, Zilbrix/Hib/Poliorix Group
Comments To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2] difference in percentage of seroprotected subjects ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 0
Confidence Interval (2-Sided) 95%
-4.78 to 4.72
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection GSK2036874A Group 3, Zilbrix/Hib/Poliorix Group
Comments To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 2 antibodies, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3] difference in percentage of seroprotected subjects ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 0
Confidence Interval (2-Sided) 95%
-4.78 to 4.72
Estimation Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection GSK2036874A Group 1, Zilbrix/Hib/Poliorix Group
Comments To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 1) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 1] difference in percentage of seroprotected subjects ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
-3.53 to 6.94
Estimation Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection GSK2036874A Group 2, Zilbrix/Hib/Poliorix Group
Comments To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 2) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 2] difference in percentage of seroprotected subjects ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 1.28
Confidence Interval (2-Sided) 95%
-3.53 to 6.94
Estimation Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection GSK2036874A Group 3, Zilbrix/Hib/Poliorix Group
Comments To demonstrate the non-inferiority of GSK2036874A vaccine (Formulation 3) compared to Poliorix™ vaccine co-administered with Zilbrix/Hib™ vaccine, in terms of seroprotection rates to the three poliovirus types and to demonstrate that the formulation induces at least a two-fold increase in the geometric mean of the individual ratios (post- over pre-booster titres) for anti-polio type 3 antibodies, one month after vaccination.
Type of Statistical Test Non-Inferiority
Comments Criterion for evaluation of Non-inferiority: The UL of the standardized asymptotic 95% CI on the group [Zilbrix/Hib/Poliorix Group - GSK2036874A Group 3] difference in percentage of seroprotected subjects ≤ 10%.
Method of Estimation Estimation Parameter Difference in seroprotection rate
Estimated Value 0
Confidence Interval (2-Sided) 95%
-4.78 to 4.72
Estimation Comments [Not Specified]
2.Primary Outcome
Title Anti-polio Types 1, 2 and 3 Antibody Titers
Hide Description Antibody titers were presented as geometric mean titers (GMTs).
Time Frame Prior to booster vaccination (At Month 0)
Hide 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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 77
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-polio 1 Number Analyzed 78 participants 78 participants 78 participants 77 participants
321.1
(231.2 to 446.0)
219.1
(144.0 to 333.6)
296.6
(205.1 to 428.8)
296.9
(213.9 to 412.1)
Anti-polio 2 Number Analyzed 77 participants 78 participants 78 participants 77 participants
186.8
(140.1 to 249.2)
152.2
(111.8 to 207.3)
183.4
(146.4 to 229.7)
148.0
(112.4 to 194.9)
Anti-polio 3 Number Analyzed 78 participants 78 participants 78 participants 77 participants
74.5
(56.0 to 99.0)
82.1
(62.1 to 108.6)
102.1
(77.6 to 134.4)
79.1
(57.9 to 108.1)
3.Primary Outcome
Title Anti-polio Types 1, 2 and 3 Antibody Titers
Hide Description Antibody titers were presented as geometric mean titers (GMTs).
Time Frame One month after booster vaccination (At Month 1)
Hide 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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 77
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-polio 1 Number Analyzed 78 participants 78 participants 78 participants 77 participants
2218.4
(1786.3 to 2755.1)
1486.7
(1065.9 to 2073.5)
1245.1
(1007.2 to 1539.2)
3760.2
(2973.7 to 4754.7)
Anti-polio 2 Number Analyzed 77 participants 78 participants 78 participants 77 participants
1598.8
(1293.5 to 1976.3)
1056.4
(841.5 to 1326.1)
966.5
(779.5 to 1198.3)
2883.2
(2275.2 to 3653.8)
Anti-polio 3 Number Analyzed 78 participants 78 participants 78 participants 77 participants
2820
(2129.9 to 3733.9)
2217.7
(1654 to 2973.4)
1915.8
(1498.1 to 2449.8)
3626.4
(2618.2 to 5022.9)
4.Secondary Outcome
Title Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3
Hide Description Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 8 ED50 one month after the booster dose. For initially seropositive subjects: antibody titer one month after the booster dose ≥ 4 fold the pre-booster antibody titer. For subjects with pre-booster antibody titer below the highest dilution tested (reciprocal < 8192 ED50): highest dilution tested one month after the booster dose (reciprocal > 8192 ED50).
Time Frame One month after booster vaccination (At Month 1)
Hide 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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 77
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-polio 1 Number Analyzed 78 participants 78 participants 78 participants 77 participants
70
  89.7%
64
  82.1%
60
  76.9%
69
  89.6%
Anti-polio 2 Number Analyzed 77 participants 78 participants 78 participants 77 participants
68
  88.3%
66
  84.6%
70
  89.7%
72
  93.5%
Anti-polio 3 Number Analyzed 78 participants 78 participants 78 participants 77 participants
74
  94.9%
74
  94.9%
73
  93.6%
75
  97.4%
5.Secondary Outcome
Title Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Hide Description Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.
Time Frame Prior to booster vaccination (At Month 0)
Hide 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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 77
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-polio 1
76
  97.4%
70
  89.7%
74
  94.9%
75
  97.4%
Anti-polio 2
77
  98.7%
75
  96.2%
78
 100.0%
74
  96.1%
Anti-polio 3
74
  94.9%
76
  97.4%
76
  97.4%
70
  90.9%
6.Secondary Outcome
Title Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
Hide Description Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 international units per milliliter (IU/mL).
Time Frame Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Hide 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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 77
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D, M0
69
  88.5%
69
  88.5%
69
  88.5%
65
  84.4%
Anti-D, M1
78
 100.0%
78
 100.0%
78
 100.0%
77
 100.0%
Anti-T, M0
78
 100.0%
77
  98.7%
77
  98.7%
76
  98.7%
Anti-T, M1
78
 100.0%
78
 100.0%
78
 100.0%
77
 100.0%
7.Secondary Outcome
Title Anti-D and Anti-T Antibody Concentrations
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time Frame Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Hide 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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 77
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D, M0
0.301
(0.237 to 0.382)
0.331
(0.258 to 0.424)
0.330
(0.264 to 0.412)
0.374
(0.276 to 0.508)
Anti-D, M1
6.519
(5.46 to 7.783)
7.687
(6.112 to 9.669)
8.659
(7.132 to 10.514)
6.807
(5.231 to 8.858)
Anti-T, M0
0.776
(0.639 to 0.942)
0.766
(0.622 to 0.944)
0.833
(0.668 to 1.038)
0.932
(0.756 to 1.149)
Anti-T, M1
26.12
(22.65 to 30.121)
31.047
(25.954 to 37.139)
31.054
(26.837 to 35.934)
24.402
(21.042 to 28.298)
8.Secondary Outcome
Title Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)
Hide Description Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.
Time Frame Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
Hide 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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 77
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-HBs ≥ 3.3 mIU/mL, M0
71
  91.0%
70
  89.7%
73
  93.6%
73
  94.8%
Anti-HBs ≥ 3.3 mIU/mL, M1
78
 100.0%
77
  98.7%
78
 100.0%
77
 100.0%
Anti-HBs ≥ 10 mIU/mL, M0
64
  82.1%
67
  85.9%
62
  79.5%
70
  90.9%
Anti-HBs ≥ 10 mIU/mL, M1
77
  98.7%
77
  98.7%
78
 100.0%
77
 100.0%
9.Secondary Outcome
Title Anti-HBs Antibody Concentrations
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time Frame Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
Hide 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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 77
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
Anti-HBs, M0
59.9
(40.3 to 89.1)
46.9
(32.8 to 67.2)
61.9
(42.2 to 91)
88.5
(60.7 to 129)
Anti-HBs, M1
2713.4
(1846.9 to 3986.2)
2395.1
(1630 to 3519.4)
3992.8
(2747.2 to 5803.1)
3484.3
(2452.2 to 4950.8)
10.Secondary Outcome
Title Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)
Hide Description Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL).
Time Frame Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subject for whom immunogenicity data were available.
Arm/Group Title GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 77
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PRP, M0
28
  35.9%
27
  34.6%
30
  38.5%
35
  45.5%
Anti-PRP, M1
77
  98.7%
76
  97.4%
71
  91.0%
76
  98.7%
11.Secondary Outcome
Title Anti-PRP Antibody Concentrations
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL.
Time Frame Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Hide 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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 77
Geometric Mean (95% Confidence Interval)
Unit of Measure: μg/mL
Anti-PRP, M0
0.134
(0.109 to 0.166)
0.137
(0.11 to 0.172)
0.152
(0.118 to 0.197)
0.171
(0.13 to 0.226)
Anti-PRP, M1
2.871
(1.797 to 4.587)
2.243
(1.52 to 3.31)
1.575
(1.065 to 2.33)
3.305
(2.373 to 4.603)
12.Secondary Outcome
Title Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)
Hide Description Seropositivity was defined as anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
Hide 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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 76 78 78 77
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-BPT, M0 Number Analyzed 76 participants 78 participants 78 participants 77 participants
50
  65.8%
50
  64.1%
51
  65.4%
49
  63.6%
Anti-BPT, M1 Number Analyzed 76 participants 74 participants 77 participants 75 participants
76
 100.0%
73
  98.6%
77
 100.0%
75
 100.0%
13.Secondary Outcome
Title Anti-BPT Antibody Concentrations
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time Frame Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Hide 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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 76 78 78 77
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-BPT, M0 Number Analyzed 76 participants 78 participants 78 participants 77 participants
19.6
(16.4 to 23.6)
20.1
(16.5 to 24.5)
18.9
(15.9 to 22.4)
19.5
(16 to 23.9)
Anti-BPT, M1 Number Analyzed 76 participants 74 participants 77 participants 75 participants
161.8
(143.6 to 182.3)
182.9
(158 to 211.9)
211
(190.1 to 234.2)
194.7
(170.6 to 222.4)
14.Secondary Outcome
Title Number of Subjects With a Booster Response for Anti-BPT
Hide Description Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose. For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration.
Time Frame One month after booster vaccination (At Month 1)
Hide 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 GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 74 74 77 75
Measure Type: Count of Participants
Unit of Measure: Participants
72
  97.3%
72
  97.3%
77
 100.0%
72
  96.0%
15.Secondary Outcome
Title Number of Subjects With Any Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame During the 8-day (Days 0-7) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 78
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
67
  85.9%
65
  83.3%
66
  84.6%
68
  87.2%
Any Redness
28
  35.9%
29
  37.2%
35
  44.9%
35
  44.9%
Any Swelling
33
  42.3%
32
  41.0%
36
  46.2%
35
  44.9%
16.Secondary Outcome
Title Number of Subjects With Any Solicited General Symptoms
Hide Description Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
Time Frame During the 8-day (Days 0-7) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 78
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness
43
  55.1%
42
  53.8%
46
  59.0%
41
  52.6%
Any Irritability
53
  67.9%
60
  76.9%
57
  73.1%
65
  83.3%
Any Loss of appetite
33
  42.3%
36
  46.2%
36
  46.2%
38
  48.7%
Any Temperature (Axillary)
59
  75.6%
60
  76.9%
57
  73.1%
63
  80.8%
17.Secondary Outcome
Title Number of Subjects With Any Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame During the 31-day (Day 0-Day 30) post-vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 78
Measure Type: Count of Participants
Unit of Measure: Participants
30
  38.5%
44
  56.4%
30
  38.5%
40
  51.3%
18.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame During the entire study period (from Month 0 to Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
Arm/Group Title GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description:
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
Overall Number of Participants Analyzed 78 78 78 78
Measure Type: Count of Participants
Unit of Measure: Participants
1
   1.3%
3
   3.8%
2
   2.6%
1
   1.3%
Time Frame Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Hide Arm/Group Description Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0. Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0. Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0. Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
All-Cause Mortality
GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/78 (0.00%)   0/78 (0.00%)   0/78 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/78 (1.28%)   3/78 (3.85%)   2/78 (2.56%)   1/78 (1.28%) 
Infections and infestations         
Pneumonia  1  1/78 (1.28%)  0/78 (0.00%)  1/78 (1.28%)  0/78 (0.00%) 
Urinary tract infection  1  1/78 (1.28%)  0/78 (0.00%)  0/78 (0.00%)  0/78 (0.00%) 
Nervous system disorders         
Febrile convulsion  1  0/78 (0.00%)  3/78 (3.85%)  1/78 (1.28%)  1/78 (1.28%) 
1
Term from vocabulary, MedDRA 16.0
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%
GSK2036874A Group 1 GSK2036874A Group 2 GSK2036874A Group 3 Zilbrix/Hib/Poliorix Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   75/78 (96.15%)   74/78 (94.87%)   76/78 (97.44%)   77/78 (98.72%) 
General disorders         
Pain  1  67/78 (85.90%)  65/78 (83.33%)  66/78 (84.62%)  68/78 (87.18%) 
Redness  1  28/78 (35.90%)  29/78 (37.18%)  35/78 (44.87%)  35/78 (44.87%) 
Swelling  1  33/78 (42.31%)  32/78 (41.03%)  36/78 (46.15%)  35/78 (44.87%) 
Drowsiness  1  43/78 (55.13%)  42/78 (53.85%)  46/78 (58.97%)  41/78 (52.56%) 
Fever  1  59/78 (75.64%)  60/78 (76.92%)  57/78 (73.08%)  63/78 (80.77%) 
Irritability  1  53/78 (67.95%)  60/78 (76.92%)  57/78 (73.08%)  65/78 (83.33%) 
Loss of appetite  1  33/78 (42.31%)  36/78 (46.15%)  36/78 (46.15%)  38/78 (48.72%) 
Infections and infestations         
Nasopharyngitis  1  3/78 (3.85%)  12/78 (15.38%)  11/78 (14.10%)  13/78 (16.67%) 
Upper respiratory tract infection  1  9/78 (11.54%)  12/78 (15.38%)  5/78 (6.41%)  9/78 (11.54%) 
Conjunctivitis bacterial  1  1/78 (1.28%)  4/78 (5.13%)  0/78 (0.00%)  0/78 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  5/78 (6.41%)  10/78 (12.82%)  9/78 (11.54%)  8/78 (10.26%) 
1
Term from vocabulary, MedDRA 16.0
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
Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01106092     History of Changes
Other Study ID Numbers: 113264
First Submitted: April 1, 2010
First Posted: April 19, 2010
Results First Submitted: March 1, 2017
Results First Posted: April 12, 2017
Last Update Posted: June 6, 2018