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Comparison of GlaxoSmithKline (GSK)134612 in Subjects With Increased Risk for Meningococcal Disease Versus Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01641042
Recruitment Status : Completed
First Posted : July 16, 2012
Results First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Infections, Meningococcal
Intervention Biological: Meningococcal vaccine GSK134612
Enrollment 86
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 Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects. Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Period Title: Overall Study
Started 43 43
Completed 43 43
Not Completed 0 0
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group Total
Hide Arm/Group Description Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects. Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects. Total of all reporting groups
Overall Number of Baseline Participants 43 43 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 43 participants 86 participants
12.0  (4.4) 11.5  (3.6) 11.75  (4.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 86 participants
Female
20
  46.5%
22
  51.2%
42
  48.8%
Male
23
  53.5%
21
  48.8%
44
  51.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 86 participants
African Heritage/African American
11
  25.6%
2
   4.7%
13
  15.1%
American Indian or Alaskan Native
0
   0.0%
2
   4.7%
2
   2.3%
White-Caucasian/European Heritage
32
  74.4%
38
  88.4%
70
  81.4%
1.Primary Outcome
Title Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Rabbit Complement Against Neisseria Meningitides Serogroups A, C, W-135 and Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY) Antibodies
Hide Description Vaccine response was defined as: rSBA antibody titers greater than or equal to (≥) 1:32, for initially seronegative subjects [i.e. pre-vaccination rSBA antibody titers below (<) 1:8] and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).
Time Frame One month after the first vaccine dose (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 eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
rSBA-MenA
40
 100.0%
39
  97.5%
rSBA-MenC
37
  92.5%
39
  97.5%
rSBA-MenW-135
40
 100.0%
39
  97.5%
rSBA-MenY
39
  97.5%
40
 100.0%
2.Primary Outcome
Title Number of Subjects With a Vaccine Response for Serum Bactericidal Assay Using Human Complement Against N. Meningitides Serogroups A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135, hSBA-MenY) Antibodies
Hide Description Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).
Time Frame One month after the first vaccine dose (at Month 1)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 38 38
Measure Type: Count of Participants
Unit of Measure: Participants
hSBA-MenA Number Analyzed 33 participants 33 participants
23
  69.7%
23
  69.7%
hSBA-MenC Number Analyzed 35 participants 33 participants
27
  77.1%
20
  60.6%
hSBA-MenW-135 Number Analyzed 36 participants 32 participants
20
  55.6%
21
  65.6%
hSBA-MenY Number Analyzed 38 participants 38 participants
23
  60.5%
29
  76.3%
3.Secondary Outcome
Title Number of Subjects With a Vaccine Response for rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibodies
Hide Description Vaccine response was defined as: rSBA antibody titers ≥ 1:32, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:8) and at least a 4-fold increase in rSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:8).
Time Frame One month after the second vaccine dose (At Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 39 39
Measure Type: Count of Participants
Unit of Measure: Participants
rSBA-MenA
39
 100.0%
39
 100.0%
rSBA-MenC
39
 100.0%
39
 100.0%
rSBA-MenW-135
39
 100.0%
39
 100.0%
rSBA-MenY
39
 100.0%
39
 100.0%
4.Secondary Outcome
Title Number of Subjects With a Vaccine Response to hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies
Hide Description Vaccine response was defined as: hSBA antibody titers ≥ 1:8, for initially seronegative subjects (i.e. pre-vaccination rSBA antibody titers < 1:4) and at least a 4-fold increase in hSBA antibody titers from pre to post-vaccination, for initially seropositive subjects (i.e. pre-vaccination rSBA antibody titers ≥ 1:4).
Time Frame One month after the second vaccine dose (At Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 37 37
Measure Type: Count of Participants
Unit of Measure: Participants
hSBA-MenA Number Analyzed 33 participants 32 participants
28
  84.8%
24
  75.0%
hSBA-MenC Number Analyzed 34 participants 34 participants
34
 100.0%
29
  85.3%
hSBA-MenW-135 Number Analyzed 36 participants 31 participants
29
  80.6%
24
  77.4%
hSBA-MenY Number Analyzed 37 participants 37 participants
27
  73.0%
27
  73.0%
5.Secondary Outcome
Title Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values
Hide Description The cut-off value for the assay was ≥ 1:8.
Time Frame At pre-primary vaccination (Month 0), at post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
rSBA-MenA; Month 0 Number Analyzed 40 participants 40 participants
7
  17.5%
2
   5.0%
rSBA-MenA; Month 1 Number Analyzed 40 participants 40 participants
40
 100.0%
40
 100.0%
rSBA-MenA; Month 3 Number Analyzed 39 participants 39 participants
39
 100.0%
39
 100.0%
rSBA-MenC; Month 0 Number Analyzed 40 participants 40 participants
10
  25.0%
5
  12.5%
rSBA-MenC; Month 1 Number Analyzed 40 participants 40 participants
37
  92.5%
39
  97.5%
rSBA-MenC; Month 3 Number Analyzed 39 participants 39 participants
39
 100.0%
39
 100.0%
rSBA-MenW-135; Month 0 Number Analyzed 40 participants 40 participants
5
  12.5%
3
   7.5%
rSBA-MenW-135; Month 1 Number Analyzed 40 participants 40 participants
40
 100.0%
39
  97.5%
rSBA-MenW-135; Month 3 Number Analyzed 39 participants 39 participants
39
 100.0%
39
 100.0%
rSBA-MenY; Month 0 Number Analyzed 40 participants 40 participants
9
  22.5%
8
  20.0%
rSBA-MenY; Month 1 Number Analyzed 40 participants 40 participants
40
 100.0%
40
 100.0%
rSBA-MenY; Month 3 Number Analyzed 39 participants 39 participants
39
 100.0%
39
 100.0%
6.Secondary Outcome
Title Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Titers ≥ the Cut-off Values
Hide Description The cut-off value for the assay was ≥ 1:128.
Time Frame Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
rSBA-MenA; Month 0 Number Analyzed 40 participants 40 participants
6
  15.0%
1
   2.5%
rSBA-MenA; Month 1 Number Analyzed 40 participants 40 participants
40
 100.0%
40
 100.0%
rSBA-MenA; Month 3 Number Analyzed 39 participants 39 participants
39
 100.0%
39
 100.0%
rSBA-MenC; Month 0 Number Analyzed 40 participants 40 participants
3
   7.5%
4
  10.0%
rSBA-MenC; Month 1 Number Analyzed 40 participants 40 participants
37
  92.5%
39
  97.5%
rSBA-MenC; Month 3 Number Analyzed 39 participants 39 participants
38
  97.4%
38
  97.4%
rSBA-MenW-135; Month 0 Number Analyzed 40 participants 40 participants
4
  10.0%
2
   5.0%
rSBA-MenW-135; Month 1 Number Analyzed 40 participants 40 participants
40
 100.0%
39
  97.5%
rSBA-MenW-135; Month 3 Number Analyzed 39 participants 39 participants
38
  97.4%
39
 100.0%
rSBA-MenY; Month 0 Number Analyzed 40 participants 40 participants
8
  20.0%
8
  20.0%
rSBA-MenY; Month 1 Number Analyzed 40 participants 40 participants
40
 100.0%
40
 100.0%
rSBA-MenY; Month 3 Number Analyzed 39 participants 39 participants
39
 100.0%
39
 100.0%
7.Secondary Outcome
Title Antibody Titers for rSBA-MenA, rSBA-MenC, rSBA-MenW-135, rSBA-MenY Meningococcal Antigens
Hide Description Antibody titers were measured in geometric mean titers (GMTs), calculated on all subjects.
Time Frame At pre-primary vaccination (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 40 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
rSBA-MenA; Month 0 Number Analyzed 40 participants 40 participants
8.6
(4.8 to 15.3)
4.8
(3.6 to 6.3)
rSBA-MenA; Month 1 Number Analyzed 40 participants 40 participants
2012.8
(1414 to 2865.3)
4025.6
(3065.1 to 5287.2)
rSBA-MenA; Month 3 Number Analyzed 39 participants 39 participants
2820.1
(1899 to 4187.9)
3553.1
(2640.3 to 4781.5)
rSBA-MenC; Month 0 Number Analyzed 40 participants 40 participants
9
(5.4 to 15)
6.3
(4.2 to 9.3)
rSBA-MenC; Month 1 Number Analyzed 40 participants 40 participants
1374.8
(693.4 to 2725.7)
2233.4
(1197.4 to 4165.6)
rSBA-MenC; Month 3 Number Analyzed 39 participants 39 participants
1684.3
(1097.8 to 2584.1)
1684.3
(1087.8 to 2608.1)
rSBA-MenW-135; Month 0 Number Analyzed 40 participants 40 participants
7
(4.2 to 11.7)
5.1
(3.8 to 6.9)
rSBA-MenW-135; Month 1 Number Analyzed 40 participants 40 participants
3050.9
(2029.8 to 4585.5)
4167.6
(2620 to 6629.2)
rSBA-MenW-135; Month 3 Number Analyzed 39 participants 39 participants
5844.3
(4046.3 to 8441.3)
6981.1
(5467.9 to 8913)
rSBA-MenY; Month 0 Number Analyzed 40 participants 40 participants
10.6
(5.7 to 19.7)
9.7
(5.4 to 17.3)
rSBA-MenY; Month 1 Number Analyzed 40 participants 40 participants
4624.2
(3125.5 to 6841.6)
7009
(5175.6 to 9491.9)
rSBA-MenY; Month 3 Number Analyzed 39 participants 39 participants
5640.2
(4142.5 to 7679.5)
6618.6
(4875.6 to 8984.6)
8.Secondary Outcome
Title Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
Hide Description The cut-off value for the assay was ≥ 1:4.
Time Frame Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
hSBA-MenA; Month 0 Number Analyzed 36 participants 35 participants
14
  38.9%
12
  34.3%
hSBA-MenA; Month 1 Number Analyzed 35 participants 37 participants
29
  82.9%
28
  75.7%
hSBA-MenA; Month 3 Number Analyzed 37 participants 36 participants
35
  94.6%
29
  80.6%
hSBA-MenC; Month 0 Number Analyzed 36 participants 35 participants
21
  58.3%
23
  65.7%
hSBA-MenC; Month 1 Number Analyzed 37 participants 38 participants
34
  91.9%
36
  94.7%
hSBA-MenC; Month 3 Number Analyzed 38 participants 39 participants
38
 100.0%
39
 100.0%
hSBA-MenW-135; Month 0 Number Analyzed 37 participants 33 participants
20
  54.1%
16
  48.5%
hSBA-MenW-135; Month 1 Number Analyzed 37 participants 39 participants
34
  91.9%
39
 100.0%
hSBA-MenW-135; Month 3 Number Analyzed 39 participants 38 participants
39
 100.0%
38
 100.0%
hSBA-MenY; Month 0 Number Analyzed 38 participants 38 participants
24
  63.2%
25
  65.8%
hSBA-MenY; Month 1 Number Analyzed 40 participants 40 participants
37
  92.5%
40
 100.0%
hSBA-MenY; Month 3 Number Analyzed 39 participants 39 participants
39
 100.0%
39
 100.0%
9.Secondary Outcome
Title Number of Subjects With hSBA-MenA, hSBA-MenC, hSBAMenW-135 and hSBA-MenY Titers ≥ the Cut-off Values
Hide Description The cut-off value for the assay ≥ 1:8.
Time Frame Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
hSBA-MenA; Month 0 Number Analyzed 36 participants 35 participants
13
  36.1%
12
  34.3%
hSBA-MenA; Month 1 Number Analyzed 35 participants 37 participants
29
  82.9%
28
  75.7%
hSBA-MenA; Month 3 Number Analyzed 37 participants 36 participants
35
  94.6%
29
  80.6%
hSBA-MenC; Month 0 Number Analyzed 36 participants 35 participants
20
  55.6%
22
  62.9%
hSBA-MenC; Month 1 Number Analyzed 37 participants 38 participants
34
  91.9%
36
  94.7%
hSBA-MenC; Month 3 Number Analyzed 38 participants 39 participants
38
 100.0%
39
 100.0%
hSBA-MenW-135; Month 0 Number Analyzed 37 participants 33 participants
20
  54.1%
16
  48.5%
hSBA-MenW-135; Month 1 Number Analyzed 37 participants 39 participants
34
  91.9%
39
 100.0%
hSBA-MenW-135; Month 3 Number Analyzed 39 participants 38 participants
39
 100.0%
38
 100.0%
hSBA-MenY; Month 0 Number Analyzed 38 participants 38 participants
24
  63.2%
25
  65.8%
hSBA-MenY; Month 1 Number Analyzed 40 participants 40 participants
37
  92.5%
40
 100.0%
hSBA-MenY; Month 3 Number Analyzed 39 participants 39 participants
39
 100.0%
39
 100.0%
10.Secondary Outcome
Title Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens
Hide Description Antibody titers were measured in Geometric mean titers (GMTs), calculated on all subjects.
Time Frame Pre-primary vaccination at Month 0, post first vaccine dose at Month 1 and post second vaccine dose at Month 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 40 40
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titres
hSBA-MenA; Month 0 Number Analyzed 36 participants 35 participants
5.5
(3.4 to 8.9)
4.2
(2.9 to 6.1)
hSBA-MenA; Month 1 Number Analyzed 35 participants 37 participants
105.9
(47.6 to 235.6)
68.7
(32.6 to 144.5)
hSBA-MenA; Month 3 Number Analyzed 37 participants 36 participants
235.1
(136.2 to 405.9)
90.3
(44.8 to 182.1)
hSBA-MenC; Month 0 Number Analyzed 36 participants 35 participants
12.9
(6.5 to 25.7)
10.9
(6.3 to 18.6)
hSBA-MenC; Month 1 Number Analyzed 37 participants 38 participants
812.9
(283.5 to 2330.9)
196.7
(84.6 to 457.2)
hSBA-MenC; Month 3 Number Analyzed 38 participants 39 participants
1472.1
(733.6 to 2954)
764.6
(404.8 to 1444.5)
hSBA-MenW-135; Month 0 Number Analyzed 37 participants 33 participants
21.7
(9.9 to 47.7)
13.6
(6.4 to 28.5)
hSBA-MenW-135; Month 1 Number Analyzed 37 participants 39 participants
283.7
(137.4 to 585.6)
263.7
(187.3 to 371.2)
hSBA-MenW-135; Month 3 Number Analyzed 39 participants 38 participants
884.5
(567.2 to 1379.2)
590.8
(443 to 787.8)
hSBA-MenY; Month 0 Number Analyzed 38 participants 38 participants
37
(16.7 to 82.4)
32
(15.5 to 65.8)
hSBA-MenY; Month 1 Number Analyzed 40 participants 40 participants
743.6
(352.9 to 1566.7)
661.7
(460.2 to 951.6)
hSBA-MenY; Month 3 Number Analyzed 39 participants 39 participants
1415.1
(905.2 to 2212.2)
800.7
(638.1 to 1004.7)
11.Secondary Outcome
Title Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Values
Hide Description The cut-off value for the assay was ≥ 0.3 micrograms per milliliter (μg/m).
Time Frame Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 33 34
Measure Type: Count of Participants
Unit of Measure: Participants
anti-PSA; Month 0 Number Analyzed 28 participants 30 participants
28
 100.0%
30
 100.0%
anti-PSA; Month 1 Number Analyzed 29 participants 34 participants
29
 100.0%
34
 100.0%
anti-PSA; Month 3 Number Analyzed 33 participants 32 participants
33
 100.0%
32
 100.0%
anti-PSC; Month 0 Number Analyzed 33 participants 34 participants
15
  45.5%
4
  11.8%
anti-PSC; Month 1 Number Analyzed 29 participants 34 participants
29
 100.0%
34
 100.0%
anti-PSC; Month 3 Number Analyzed 33 participants 32 participants
33
 100.0%
32
 100.0%
anti-PSW-135; Month 0 Number Analyzed 28 participants 30 participants
21
  75.0%
19
  63.3%
anti-PSW-135; Month 1 Number Analyzed 29 participants 34 participants
29
 100.0%
34
 100.0%
anti-PSW-135; Month 3 Number Analyzed 33 participants 32 participants
33
 100.0%
32
 100.0%
anti-PSY; Month 0 Number Analyzed 7 participants 5 participants
7
 100.0%
5
 100.0%
anti-PSY; Month 1 Number Analyzed 10 participants 13 participants
10
 100.0%
13
 100.0%
anti-PSY; Month 3 Number Analyzed 10 participants 11 participants
10
 100.0%
11
 100.0%
12.Secondary Outcome
Title Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentration ≥ the Cut-off Values
Hide Description The cut-off value for the assay was ≥ 2.0 μg/mL.
Time Frame Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 33 34
Measure Type: Count of Participants
Unit of Measure: Participants
anti-PSA; Month 0 Number Analyzed 28 participants 30 participants
12
  42.9%
9
  30.0%
anti-PSA; Month 1 Number Analyzed 29 participants 34 participants
29
 100.0%
34
 100.0%
anti-PSA; Month 3 Number Analyzed 33 participants 32 participants
33
 100.0%
32
 100.0%
anti-PSC; Month 0 Number Analyzed 33 participants 34 participants
3
   9.1%
2
   5.9%
anti-PSC; Month 1 Number Analyzed 29 participants 34 participants
26
  89.7%
32
  94.1%
anti-PSC; Month 3 Number Analyzed 33 participants 32 participants
30
  90.9%
27
  84.4%
anti-PSW-135; Month 0 Number Analyzed 28 participants 30 participants
4
  14.3%
2
   6.7%
anti-PSW-135; Month 1 Number Analyzed 29 participants 34 participants
28
  96.6%
33
  97.1%
anti-PSW-135; Month 3 Number Analyzed 33 participants 32 participants
33
 100.0%
32
 100.0%
anti-PSY; Month 0 Number Analyzed 7 participants 5 participants
3
  42.9%
3
  60.0%
anti-PSY; Month 1 Number Analyzed 10 participants 13 participants
10
 100.0%
13
 100.0%
anti-PSY; Month 3 Number Analyzed 10 participants 11 participants
10
 100.0%
11
 100.0%
13.Secondary Outcome
Title Antibody Titers for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Meningococcal Antigens
Hide Description Antibody titers were measured in geometric mean concentrations (GMCs), calculated on all subjects.
Time Frame Pre-primary vaccinarion (Month 0), post first vaccine dose (Month 1) and post second vaccine dose (Month 3)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the ATP cohort for immunogenicity, which included all eligible subjects who complied with the blood sample schedule for Visit 2 (Month 1) and Visit 4 (Month 3), for whom data concerning immunogenicity endpoint measures were available for at least one antigen component of the vaccine.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 33 34
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
anti-PSA; Month 0 Number Analyzed 28 participants 30 participants
1.9
(1.5 to 2.4)
1.4
(1.1 to 1.8)
anti-PSA; Month 1 Number Analyzed 29 participants 34 participants
17.4
(11.7 to 25.8)
16.2
(11.3 to 23.3)
anti-PSA; Month 3 Number Analyzed 33 participants 32 participants
14.2
(10.5 to 19.3)
10.7
(8 to 14.3)
anti-PSC; Month 0 Number Analyzed 33 participants 34 participants
0.4
(0.2 to 0.6)
0.2
(0.1 to 0.3)
anti-PSC; Month 1 Number Analyzed 29 participants 34 participants
8.3
(5.6 to 12.5)
8.4
(5.9 to 11.8)
anti-PSC; Month 3 Number Analyzed 33 participants 32 participants
6
(4.4 to 8.1)
5.8
(4.2 to 8)
anti-PSW-135; Month 0 Number Analyzed 28 participants 30 participants
0.6
(0.3 to 1.1)
0.4
(0.3 to 0.6)
anti-PSW-135; Month 1 Number Analyzed 29 participants 34 participants
14.9
(8.4 to 26.3)
13.3
(9.2 to 19.4)
anti-PSW-135; Month 3 Number Analyzed 33 participants 32 participants
19
(12.8 to 28.2)
14
(9.9 to 19.8)
anti-PSY; Month 0 Number Analyzed 7 participants 5 participants
2.9
(1.1 to 7.9)
2.5
(1 to 6.1)
anti-PSY; Month 1 Number Analyzed 10 participants 13 participants
20.4
(6.3 to 66.2)
17.3
(11.2 to 26.8)
anti-PSY; Month 3 Number Analyzed 10 participants 11 participants
30
(10.4 to 86.5)
12.5
(9.4 to 16.7)
14.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 1-5 Years
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time Frame During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 3 participants 3 participants
2
  66.7%
0
   0.0%
Grade 3 Pain, Dose 1 Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
Any Redness, Dose 1 Number Analyzed 3 participants 3 participants
2
  66.7%
0
   0.0%
Grade 3 Redness, Dose 1 Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 3 participants 3 participants
2
  66.7%
0
   0.0%
Grade 3 Swelling, Dose 1 Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
Any Pain, Dose 2 Number Analyzed 3 participants 2 participants
1
  33.3%
1
  50.0%
Grade 3 Pain, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Any Redness, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Grade 3 Redness, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Grade 3 Swelling, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Any Pain, Across Doses Number Analyzed 3 participants 3 participants
2
  66.7%
1
  33.3%
Grade 3 Pain, Across Doses Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
Any Redness, Across Doses Number Analyzed 3 participants 3 participants
2
  66.7%
0
   0.0%
Grade 3 Redness, Across Doses Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
Any Swelling, Across Doses Number Analyzed 3 participants 3 participants
2
  66.7%
0
   0.0%
Grade 3 Swelling, Across Doses Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms at Age Stratum 6-17 Years
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any was defined as occurrence of the symptom regardless of intensity grade. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond 30 millimeters (mm) of injection site.
Time Frame During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 40 39
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1 Number Analyzed 40 participants 39 participants
28
  70.0%
23
  59.0%
Grade 3 Pain, Dose 1 Number Analyzed 40 participants 39 participants
2
   5.0%
1
   2.6%
Any Redness, Dose 1 Number Analyzed 40 participants 39 participants
7
  17.5%
13
  33.3%
Grade 3 Redness, Dose 1 Number Analyzed 40 participants 39 participants
0
   0.0%
0
   0.0%
Any Swelling, Dose 1 Number Analyzed 40 participants 39 participants
12
  30.0%
8
  20.5%
Grade 3 Swelling, Dose 1 Number Analyzed 40 participants 39 participants
2
   5.0%
2
   5.1%
Any Pain, Dose 2 Number Analyzed 38 participants 38 participants
29
  76.3%
24
  63.2%
Grade 3 Pain, Dose 2 Number Analyzed 38 participants 38 participants
3
   7.9%
1
   2.6%
Any Redness, Dose 2 Number Analyzed 38 participants 38 participants
12
  31.6%
8
  21.1%
Grade 3 Redness, Dose 2 Number Analyzed 38 participants 38 participants
1
   2.6%
0
   0.0%
Any Swelling, Dose 2 Number Analyzed 38 participants 38 participants
12
  31.6%
10
  26.3%
Grade 3 Swelling, Dose 2 Number Analyzed 38 participants 38 participants
3
   7.9%
2
   5.3%
Any Pain, Across Doses Number Analyzed 40 participants 39 participants
32
  80.0%
28
  71.8%
Grade 3 Pain, Across Doses Number Analyzed 40 participants 39 participants
4
  10.0%
2
   5.1%
Any Redness, Across Doses Number Analyzed 40 participants 39 participants
14
  35.0%
14
  35.9%
Grade 3 Redness, Across Doses Number Analyzed 40 participants 39 participants
1
   2.5%
0
   0.0%
Any Swelling, Across Doses Number Analyzed 40 participants 39 participants
18
  45.0%
12
  30.8%
Grade 3 Swelling, Across Doses Number Analyzed 40 participants 39 participants
4
  10.0%
3
   7.7%
16.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 1-5 Years
Hide Description Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness, Dose 1 Number Analyzed 3 participants 3 participants
3
 100.0%
1
  33.3%
Grade 3 Drowsiness, Dose 1 Number Analyzed 3 participants 3 participants
1
  33.3%
0
   0.0%
Related Drowsiness, Dose 1 Number Analyzed 3 participants 3 participants
3
 100.0%
0
   0.0%
Any Irritability, Dose 1 Number Analyzed 3 participants 3 participants
2
  66.7%
1
  33.3%
Grade 3 Irritability, Dose 1 Number Analyzed 3 participants 3 participants
1
  33.3%
0
   0.0%
Related Irritability, Dose 1 Number Analyzed 3 participants 3 participants
2
  66.7%
0
   0.0%
Any Loss of appetite, Dose 1 Number Analyzed 3 participants 3 participants
2
  66.7%
0
   0.0%
Grade 3 Loss of appetite, Dose 1 Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
Related Loss of appetite, Dose 1 Number Analyzed 3 participants 3 participants
2
  66.7%
0
   0.0%
Any Fever, Dose 1 Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
Grade 3 Fever, Dose 1 Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
Related Fever, Dose 1 Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
Any Drowsiness, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
1
  50.0%
Grade 3 Drowsiness, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Related Drowsiness, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
1
  50.0%
Any Irritability, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
1
  50.0%
Grade 3 Irritability, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Related Irritability, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
1
  50.0%
Any Loss of appetite, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Grade 3 Loss of appetite, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Related Loss of appetite, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Any Fever, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Grade 3 Fever, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Related Fever, Dose 2 Number Analyzed 3 participants 2 participants
0
   0.0%
0
   0.0%
Any Drowsiness, Across doses Number Analyzed 3 participants 3 participants
3
 100.0%
2
  66.7%
Grade 3 Drowsiness, Across doses Number Analyzed 3 participants 3 participants
1
  33.3%
0
   0.0%
Related Drowsiness, Across doses Number Analyzed 3 participants 3 participants
3
 100.0%
1
  33.3%
Any Irritability, Across doses Number Analyzed 3 participants 3 participants
2
  66.7%
2
  66.7%
Grade 3 Irritability, Across doses Number Analyzed 3 participants 3 participants
1
  33.3%
0
   0.0%
Related Irritability, Across doses Number Analyzed 3 participants 3 participants
2
  66.7%
1
  33.3%
Any Loss of appetite, Across doses Number Analyzed 3 participants 3 participants
2
  66.7%
0
   0.0%
Grade 3 Loss of appetite, Across doses Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
Related Loss of appetite, Across doses Number Analyzed 3 participants 3 participants
2
  66.7%
0
   0.0%
Any Fever, Across doses Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
Grade 3 Fever, Across doses Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
Related Fever, Across doses Number Analyzed 3 participants 3 participants
0
   0.0%
0
   0.0%
17.Secondary Outcome
Title Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms at Age Stratum 6-17 Years
Hide Description Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and fever. Gastrointestinal symptoms include nausea, vomiting, diarrhoea and/or abdominal pain. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptoms = symptoms which prevented normal everyday activities. Grade 3 fever = oral temperature >39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame During the 4-day (Days 0-3) post-vaccination period following each dose and across doses
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and with their symptom sheet filled in.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 40 39
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue, Dose 1 Number Analyzed 40 participants 39 participants
18
  45.0%
12
  30.8%
Grade 3 Fatigue, Dose 1 Number Analyzed 40 participants 39 participants
1
   2.5%
0
   0.0%
Related Fatigue, Dose 1 Number Analyzed 40 participants 39 participants
17
  42.5%
12
  30.8%
Any Gastrointestinal, Dose 1 Number Analyzed 40 participants 39 participants
5
  12.5%
3
   7.7%
Grade 3 Gastrointestinal, Dose 1 Number Analyzed 40 participants 39 participants
0
   0.0%
0
   0.0%
Related Gastrointestinal, Dose 1 Number Analyzed 40 participants 39 participants
4
  10.0%
3
   7.7%
Any Headache, Dose 1 Number Analyzed 40 participants 39 participants
12
  30.0%
9
  23.1%
Grade 3 Headache, Dose 1 Number Analyzed 40 participants 39 participants
0
   0.0%
0
   0.0%
Related Headache, Dose 1 Number Analyzed 40 participants 39 participants
9
  22.5%
9
  23.1%
Any Fever, Dose 1 Number Analyzed 40 participants 39 participants
3
   7.5%
0
   0.0%
Grade 3 Fever, Dose 1 Number Analyzed 40 participants 39 participants
0
   0.0%
0
   0.0%
Related Fever, Dose 1 Number Analyzed 40 participants 39 participants
2
   5.0%
0
   0.0%
Any Fatigue, Dose 2 Number Analyzed 38 participants 38 participants
13
  34.2%
7
  18.4%
Grade 3 Fatigue, Dose 2 Number Analyzed 38 participants 38 participants
0
   0.0%
1
   2.6%
Related Fatigue, Dose 2 Number Analyzed 38 participants 38 participants
13
  34.2%
6
  15.8%
Any Gastrointestinal, Dose 2 Number Analyzed 38 participants 38 participants
1
   2.6%
6
  15.8%
Grade 3 Gastrointestinal, Dose 2 Number Analyzed 38 participants 38 participants
0
   0.0%
2
   5.3%
Related Gastrointestinal, Dose 2 Number Analyzed 38 participants 38 participants
1
   2.6%
3
   7.9%
Any Headache, Dose 2 Number Analyzed 38 participants 38 participants
7
  18.4%
5
  13.2%
Grade 3 Headache, Dose 2 Number Analyzed 38 participants 38 participants
0
   0.0%
1
   2.6%
Related Headache, Dose 2 Number Analyzed 38 participants 38 participants
6
  15.8%
4
  10.5%
Any Fever, Dose 2 Number Analyzed 38 participants 38 participants
1
   2.6%
2
   5.3%
Grade 3 Fever, Dose 2 Number Analyzed 38 participants 38 participants
0
   0.0%
0
   0.0%
Related Fever, Dose 2 Number Analyzed 38 participants 38 participants
1
   2.6%
1
   2.6%
Any Fatigue, Across doses Number Analyzed 40 participants 39 participants
21
  52.5%
14
  35.9%
Grade 3 Fatigue, Across doses Number Analyzed 40 participants 39 participants
1
   2.5%
1
   2.6%
Related Fatigue, Across doses Number Analyzed 40 participants 39 participants
21
  52.5%
14
  35.9%
Any Gastrointestinal, Across doses Number Analyzed 40 participants 39 participants
6
  15.0%
8
  20.5%
Grade 3 Gastrointestinal, Across doses Number Analyzed 40 participants 39 participants
0
   0.0%
2
   5.1%
Related Gastrointestinal, Across doses Number Analyzed 40 participants 39 participants
5
  12.5%
5
  12.8%
Any Headache, Across doses Number Analyzed 40 participants 39 participants
16
  40.0%
10
  25.6%
Grade 3 Headache, Across doses Number Analyzed 40 participants 39 participants
0
   0.0%
1
   2.6%
Related Headache, Across doses Number Analyzed 40 participants 39 participants
14
  35.0%
10
  25.6%
Any Fever, Across doses Number Analyzed 40 participants 39 participants
4
  10.0%
2
   5.1%
Grade 3 Fever, Across doses Number Analyzed 40 participants 39 participants
0
   0.0%
0
   0.0%
Related Fever, Across doses Number Analyzed 40 participants 39 participants
3
   7.5%
1
   2.6%
18.Secondary Outcome
Title Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
Hide Description NOCIs include autoimmune disorders, asthma, type 1 diabetes and allergies.
Time Frame From Month 0 until the end of the Extended Safety Follow-Up [ESFU] (at Month 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)
Hide Description An unsolicited adverse event (AE) covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
Time Frame During the 31-day (Days 0-30) post first vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
7
  16.3%
7
  16.3%
20.Secondary Outcome
Title Number of Subjects Reporting Any Unsolicited AEs
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical subject investigation temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.
Time Frame During the 31-day (Days 0-30) post second vaccination period
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
3
   7.0%
8
  18.6%
21.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 From Month 0 until the end of the ESFU (at Month 8)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Arm/Group Title Nimenrix At-Risk Group Nimenrix Healthy Group
Hide Arm/Group Description:
Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
Overall Number of Participants Analyzed 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
4
   9.3%
1
   2.3%
Time Frame Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period, Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period; SAEs: from Month 0 up to the end of the ESFU Phase (at Month 8).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nimenrix At-risk Group Nimenrix Healthy Group
Hide Arm/Group Description Male or female subjects, aged 1 to 17 years of age, with an increased risk for meningococcal disease due to anatomic asplenia or some degree of functional asplenia, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2. The vaccine was administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects. Healthy male or female subjects, aged 1 to 17 years of age, who received 2 doses of the Nimenrix vaccine at Month 0 and Month 2, administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
All-Cause Mortality
Nimenrix At-risk Group Nimenrix Healthy Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)      0/43 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Nimenrix At-risk Group Nimenrix Healthy Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/43 (9.30%)      1/43 (2.33%)    
Blood and lymphatic system disorders     
Sickle cell anaemia with crisis  1  1/43 (2.33%)  1 0/43 (0.00%)  0
Infections and infestations     
Cystitis escherichia  1  1/43 (2.33%)  1 0/43 (0.00%)  0
Pneumococcal bacteraemia  1  1/43 (2.33%)  1 0/43 (0.00%)  0
Salmonellosis  1  1/43 (2.33%)  1 0/43 (0.00%)  0
Injury, poisoning and procedural complications     
Joint injury  1  0/43 (0.00%)  0 1/43 (2.33%)  1
1
Term from vocabulary, MedDRA 18.0
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%
Nimenrix At-risk Group Nimenrix Healthy Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   38/43 (88.37%)      34/43 (79.07%)    
Gastrointestinal disorders     
Gastrointestinal disorder  1  6/43 (13.95%)  6 8/43 (18.60%)  9
General disorders     
Fatigue  1  21/43 (48.84%)  31 14/43 (32.56%)  19
Pain  1  34/43 (79.07%)  60 29/43 (67.44%)  48
Pyrexia  1  5/43 (11.63%)  5 2/43 (4.65%)  2
Swelling  1  20/43 (46.51%)  26 12/43 (27.91%)  18
Nervous system disorders     
Headache  1  16/43 (37.21%)  19 10/43 (23.26%)  14
Somnolence  1  3/43 (6.98%)  3 2/43 (4.65%)  2
Skin and subcutaneous tissue disorders     
Erythema  1  16/43 (37.21%)  21 14/43 (32.56%)  21
1
Term from vocabulary, MedDRA 18.0
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01641042     History of Changes
Other Study ID Numbers: 115524
2011-002410-36 ( EudraCT Number )
First Submitted: July 12, 2012
First Posted: July 16, 2012
Results First Submitted: September 21, 2017
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017