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A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02548078
Recruitment Status : Completed
First Posted : September 14, 2015
Results First Posted : May 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Condition Virus Diseases
Interventions Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
Biological: Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine
Enrollment 600
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Period Title: Overall Study
Started 300 300
Completed 295 294
Not Completed 5 6
Reason Not Completed
Serious adverse event/Adverse event             1             0
Moved from study area             3             3
Lost to Follow-up             1             3
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group Total
Hide Arm/Group Description Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. Total of all reporting groups
Overall Number of Baseline Participants 300 300 600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 300 participants 300 participants 600 participants
9.0  (4.95) 8.8  (5.03) 8.90  (4.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants 300 participants 600 participants
Female
149
  49.7%
150
  50.0%
299
  49.8%
Male
151
  50.3%
150
  50.0%
301
  50.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
AFRICAN HERITAGE/AFRICAN AMERICAN Number Analyzed 300 participants 300 participants 600 participants
300
 100.0%
300
 100.0%
600
 100.0%
1.Primary Outcome
Title Number of Subjects With Solicited Local Symptoms, Overall
Hide Description Assessed solicited local symptoms included: pain and swelling at the injections site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying at limb movement/spontaneous pain.Grade 3 swelling = swelling extending on a surface higher than (>) 30 millimeters (mm). Solicited local symptoms, for this endpoint, were assessed in all subjects, in both groups.
Time Frame During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 300 300
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
127
  42.3%
60
  20.0%
Grade 3 Pain
4
   1.3%
0
   0.0%
Any Swelling
5
   1.7%
1
   0.3%
Grade 3 Swelling
1
   0.3%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With Solicited Local Symptoms, by Age Stratum
Hide Description Assessed solicited local symptoms included: pain and swelling at the injections site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying at limb movement/spontaneous pain.Grade 3 swelling = swelling extending on a surface higher than (>) 30 millimeters (mm), for children between 1-5 years old; > 50 mm for children between 6-12 years old and >100 mm for children between 13-17 years old.
Time Frame During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 100 99 101 101 99
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain
31
  31.0%
14
  14.0%
41
  41.4%
23
  22.8%
55
  54.5%
23
  23.2%
Grade 3 Pain
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
3
   3.0%
0
   0.0%
Any Swelling
1
   1.0%
0
   0.0%
3
   3.0%
1
   1.0%
1
   1.0%
0
   0.0%
Grade 3 Swelling
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Number of Subjects With Solicited General Symptoms, Overall
Hide Description Solicited general symptoms assessed included: fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue/headache/drowsiness/gastrointestinal symptoms = fatigue/headache/drowsiness/gastrointestinal symptoms that prevented normal activity. Grade 3 fever = temperature > 39.5°C. Grade 3 irritability/fussiness = crying that couldn't be comforted. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. Solicited general symptoms, for this endpoint, were assessed in all subjects, in both groups.
Time Frame During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 300 300
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue
33
  11.0%
6
   2.0%
Grade 3 Fatigue
0
   0.0%
0
   0.0%
Related Fatigue
32
  10.7%
5
   1.7%
Any Fever
95
  31.7%
28
   9.3%
Grade 3 Fever
1
   0.3%
0
   0.0%
Related Fever
89
  29.7%
26
   8.7%
Any Gastrointestinal symptoms
16
   5.3%
6
   2.0%
Grade 3 Gastrointestinal symptoms
0
   0.0%
0
   0.0%
Related Gastrointestinal symptoms
13
   4.3%
3
   1.0%
Any Headache
62
  20.7%
17
   5.7%
Grade 3 Headache
0
   0.0%
0
   0.0%
Related Headache
60
  20.0%
14
   4.7%
Any Drowsiness
26
   8.7%
2
   0.7%
Grade 3 Drowsiness
3
   1.0%
0
   0.0%
Related Drowsiness
26
   8.7%
1
   0.3%
Any Irritability/fussiness
10
   3.3%
2
   0.7%
Grade 3 Irritability/fussiness
4
   1.3%
0
   0.0%
Related Irritability/fussiness
10
   3.3%
2
   0.7%
Any Loss of appetite
24
   8.0%
4
   1.3%
Grade 3 Loss of appetite
3
   1.0%
0
   0.0%
Related Loss of appetite
24
   8.0%
4
   1.3%
4.Primary Outcome
Title Number of Subjects With Solicited General Symptoms, by Age Stratum
Hide Description Solicited general symptoms assessed included: fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue/headache/drowsiness/gastrointestinal symptoms = fatigue/headache/drowsiness/gastrointestinal symptoms that prevented normal activity. Grade 3 fever = temperature > 39.5°C. Grade 3 irritability/fussiness = crying that couldn't be comforted. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. Solicited general symptoms, for this endpoint, were assessed in subjects aged 1-5 years, 6-12 years and 13-17 years. Symptoms with no values were not assessed for those specific age groups.
Time Frame During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 100 99 101 101 99
Measure Type: Count of Participants
Unit of Measure: Participants
Any Fatigue Number Analyzed 100 participants 100 participants 99 participants 101 participants 0 participants 0 participants
20
  20.0%
5
   5.0%
13
  13.1%
1
   1.0%
Grade 3 Fatigue Number Analyzed 100 participants 100 participants 99 participants 101 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Fatigue Number Analyzed 100 participants 100 participants 99 participants 101 participants 0 participants 0 participants
20
  20.0%
4
   4.0%
12
  12.1%
1
   1.0%
Any Fever Number Analyzed 100 participants 100 participants 99 participants 101 participants 101 participants 99 participants
20
  20.0%
4
   4.0%
25
  25.3%
1
   1.0%
50
  49.5%
23
  23.2%
Grade 3 Fever Number Analyzed 100 participants 100 participants 99 participants 101 participants 101 participants 99 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.0%
0
   0.0%
Related Fever Number Analyzed 100 participants 100 participants 99 participants 101 participants 101 participants 99 participants
17
  17.0%
4
   4.0%
23
  23.2%
1
   1.0%
49
  48.5%
21
  21.2%
Any Gastrointestinal symptoms Number Analyzed 100 participants 100 participants 99 participants 101 participants 0 participants 0 participants
9
   9.0%
2
   2.0%
7
   7.1%
4
   4.0%
Grade 3 Gastrointestinal symptoms Number Analyzed 100 participants 100 participants 99 participants 101 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Gastrointestinal symptoms Number Analyzed 100 participants 100 participants 99 participants 101 participants 0 participants 0 participants
8
   8.0%
0
   0.0%
5
   5.1%
3
   3.0%
Any Headache Number Analyzed 100 participants 100 participants 99 participants 101 participants 0 participants 0 participants
36
  36.0%
11
  11.0%
26
  26.3%
6
   5.9%
Grade 3 Headache Number Analyzed 100 participants 100 participants 99 participants 101 participants 0 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Related Headache Number Analyzed 100 participants 100 participants 99 participants 101 participants 0 participants 0 participants
35
  35.0%
8
   8.0%
25
  25.3%
6
   5.9%
Any Drowsiness Number Analyzed 0 participants 0 participants 0 participants 0 participants 101 participants 99 participants
26
  25.7%
2
   2.0%
Grade 3 Drowsiness Number Analyzed 0 participants 0 participants 0 participants 0 participants 101 participants 99 participants
3
   3.0%
0
   0.0%
Related Drowsiness Number Analyzed 0 participants 0 participants 0 participants 0 participants 101 participants 99 participants
26
  25.7%
1
   1.0%
Any Irritability/fusiness Number Analyzed 0 participants 0 participants 0 participants 0 participants 101 participants 99 participants
10
   9.9%
2
   2.0%
Grade 3 Irritability/fusiness Number Analyzed 0 participants 0 participants 0 participants 0 participants 101 participants 99 participants
4
   4.0%
0
   0.0%
Related Irritability/fusiness Number Analyzed 0 participants 0 participants 0 participants 0 participants 101 participants 99 participants
10
   9.9%
2
   2.0%
Any Loss of appetite Number Analyzed 0 participants 0 participants 0 participants 0 participants 101 participants 99 participants
24
  23.8%
4
   4.0%
Grade 3 Loss of appetite Number Analyzed 0 participants 0 participants 0 participants 0 participants 101 participants 99 participants
3
   3.0%
0
   0.0%
Related Loss of appetite Number Analyzed 0 participants 0 participants 0 participants 0 participants 101 participants 99 participants
24
  23.8%
4
   4.0%
5.Primary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs), Overall
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. Unsolicited adverse events, for this endpoint, were assessed in all subjects, in both groups.
Time Frame During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 300 300
Measure Type: Count of Participants
Unit of Measure: Participants
41
  13.7%
24
   8.0%
6.Primary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum
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. Unsolicited AEs, for this endpoint, were assessed in subjects between 1-5 years of age, 6-12 years of age and 13-17 years of age.
Time Frame During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 100 99 101 101 99
Measure Type: Count of Participants
Unit of Measure: Participants
12
  12.0%
8
   8.0%
6
   6.1%
10
   9.9%
23
  22.8%
6
   6.1%
7.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Screening.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 257 258
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 3.9 2.7
RBC, Normal 84.4 81.8
RBC, High 11.7 15.5
Neutrophils, Low 12.8 10.9
Neutrophils, Normal 86.4 89.1
Neutrophils, High 0.8 0
Lymphocytes, Low 1.6 0
Lymphocytes, Normal 97.3 97.3
Lymphocytes, High 1.2 2.7
WBC, Low 3.5 1.2
WBC, Normal 94.9 97.3
WBC, High 1.6 1.6
Haemoglobin, Low 33.5 32.9
Haemoglobin, Normal 66.1 67.1
Haemoglobin, High 0.4 0
Platelets, Low 1.2 1.2
Platelets, Normal 80.2 77.5
Platelets, High 18.7 21.3
8.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 100 89 91 68 67
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 7.0 5.0 1.1 1.1 2.9 1.5
RBC, Normal 80.0 81.0 84.3 78.0 91.2 88.1
RBC, High 13.0 14.0 14.6 20.9 5.9 10.4
Neutrophils, Low 28.0 20.0 0 4.4 7.4 6.0
Neutrophils, Normal 72.0 80.0 97.8 95.6 92.6 94.0
Neutrophils, High 0 0 2.2 0 0 0
Lymphocytes, Low 0 0 0 0 5.9 0
Lymphocytes, Normal 98.0 95.0 100.0 97.8 92.6 100.0
Lymphocytes, High 2.0 5.0 0 2.2 1.5 0
WBC, Low 3.0 0 0 0 8.8 4.5
WBC, Normal 95.0 97.0 98.9 98.9 89.7 95.5
WBC, High 2.0 3.0 1.1 1.1 1.5 0
Haemoglobin, Low 38.0 36.0 14.6 14.3 51.5 53.7
Haemoglobin, Normal 62.0 64.0 85.4 85.7 47.1 46.3
Haemoglobin, High 0 0 0 0 1.5 0
Platelets, Low 0 0 0 0 4.4 4.5
Platelets, Normal 74.0 71.0 80.9 78.0 88.2 86.6
Platelets, High 26.0 29.0 19.1 22.0 7.4 9.0
9.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Day 3.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 257 256
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 5.1 6.3
RBC, Normal 86.8 82.4
RBC, High 8.2 11.3
Neutrophils, Low 28.4 11.7
Neutrophils, Normal 71.2 88.3
Neutrophils, High 0.4 0
Lymphocytes, Low 0.8 0
Lymphocytes, Normal 98.4 99.2
Lymphocytes, High 0.8 0.8
WBC, Low 7.8 2.3
WBC, Normal 90.7 96.1
WBC, High 1.6 1.6
Haemoglobin, Low 41.2 46.1
Haemoglobin, Normal 58.8 53.1
Haemoglobin, High 0 0.8
Platelets, Low 0.8 1.2
Platelets, Normal 87.5 82.4
Platelets, High 11.7 16.4
10.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOAGroup Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 100 89 91 68 65
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 6.0 9.0 2.2 4.4 7.4 4.6
RBC, Normal 82.0 80.0 89.9 82.4 89.7 86.2
RBC, High 12.0 11.0 7.9 13.2 2.9 9.2
Neutrophils, Low 47.0 22.0 14.6 4.4 19.1 6.2
Neutrophils, Normal 53.0 78.0 85.4 95.6 79.4 93.8
Neutrophils, High 0 0 0 0 1.5 0
Lymphocytes, Low 0 0 0 0 2.9 0
Lymphocytes, Normal 99.0 99.0 100.0 98.9 95.6 100.0
Lymphocytes, High 1.0 1.0 0 1.1 1.5 0
WBC, Low 6.0 2.0 4.5 2.2 14.7 3.1
WBC, Normal 92.0 94.0 95.5 97.8 82.4 96.9
WBC, High 2.0 4.0 0 0 2.9 0
Haemoglobin, Low 43.0 44.0 23.6 33.0 61.8 67.7
Haemoglobin, Normal 57.0 56.0 76.4 67.0 38.2 29.2
Haemoglobin, High 0 0 0 0 0 3.1
Platelets, Low 0 0 0 0 2.9 4.6
Platelets, Normal 79.0 77.0 93.3 84.6 92.6 87.7
Platelets, High 21.0 23.0 6.7 15.4 4.4 7.7
11.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Day 6.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 256 256
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 7.0 5.5
RBC, Normal 83.6 84.0
RBC, High 9.4 10.5
Neutrophils, Low 19.9 14.8
Neutrophils, Normal 79.3 84.8
Neutrophils, High 0.8 0.4
Lymphocytes, Low 1.2 0.8
Lymphocytes, Normal 97.7 97.3
Lymphocytes, High 1.2 2.0
WBC, Low 4.7 2.0
WBC, Normal 94.1 96.5
WBC, High 1.2 1.6
Haemoglobin, Low 42.6 44.1
Haemoglobin, Normal 57.4 55.1
Haemoglobin, High 0 0.8
Platelets, Low 2.3 2.0
Platelets, Normal 79.7 77.3
Platelets, High 18.0 20.7
12.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 99 98 89 91 68 67
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 12.1 8.2 2.2 3.3 5.9 4.5
RBC, Normal 74.7 82.7 88.8 82.4 89.7 88.1
RBC, High 13.1 9.2 9.0 14.3 4.4 7.5
Neutrophils, Low 37.4 29.6 6.7 6.6 11.8 4.5
Neutrophils, Normal 61.6 69.4 92.1 93.4 88.2 95.5
Neutrophils, High 1.0 1.0 1.1 0 0 0
Lymphocytes, Low 1.0 0 0 0 2.9 3.0
Lymphocytes, Normal 97.0 95.9 98.9 98.9 97.1 97.0
Lymphocytes, High 2.0 4.1 1.1 1.1 0 0
WBC, Low 5.1 1.0 0 1.1 10.3 4.5
WBC, Normal 91.9 94.9 100.0 98.9 89.7 95.5
WBC, High 3.0 4.1 0 0 0 0
Haemoglobin, Low 50.5 40.8 22.5 36.3 57.4 59.7
Haemoglobin, Normal 49.5 59.2 77.5 63.7 42.6 37.3
Haemoglobin, High 0 0 0 0 0 3
Platelets, Low 0 0 0 0 8.8 7.5
Platelets, Normal 71.7 71.4 83.1 80.2 86.8 82.1
Platelets, High 28.3 28.6 16.9 19.8 4.4 10.4
13.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Day 30.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 257 256
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 4.7 3.5
RBC, Normal 83.7 82.4
RBC, High 11.7 14.1
Neutrophils, Low 18.3 15.6
Neutrophils, Normal 80.9 83.6
Neutrophils, High 0.8 0.8
Lymphocytes, Low 1.9 0.4
Lymphocytes, Normal 96.1 97.7
Lymphocytes, High 1.9 2.0
WBC, Low 5.4 3.1
WBC, Normal 93.0 95.3
WBC, High 1.6 1.6
Haemoglobin, Low 39.7 35.5
Haemoglobin, Normal 59.5 62.5
Haemoglobin, High 0.8 2.0
Platelets, Low 1.6 1.2
Platelets, Normal 87.9 84.0
Platelets, High 10.5 14.8
14.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 98 89 91 68 67
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 9.0 6.1 2.2 2.2 1.5 1.5
RBC, Normal 73.0 75.5 88.8 85.7 92.6 88.1
RBC, High 18.0 18.4 9.0 12.1 5.9 10.4
Neutrophils, Low 35.0 30.6 11.2 5.5 2.9 7.5
Neutrophils, Normal 65.0 69.4 87.6 92.3 95.6 92.5
Neutrophils, High 0 0 1.1 2.2 1.5 0
Lymphocytes, Low 0 0 0 0 7.4 1.5
Lymphocytes, Normal 98.0 96.9 97.8 100.0 91.2 95.5
Lymphocytes, High 2.0 3.1 2.2 0 1.5 3.0
WBC, Low 5.0 3.1 4.5 3.3 7.4 3.0
WBC, Normal 94.0 95.9 93.3 95.6 91.2 94.0
WBC, High 1.0 1.0 2.2 1.1 1.5 3.0
Haemoglobin, Low 37.0 31.6 38.2 35.2 45.6 41.8
Haemoglobin, Normal 62.0 67.3 61.8 64.8 52.9 52.2
Haemoglobin, High 1.0 1.0 0 0 1.5 6.0
Platelets, Low 0 0 0 0 5.9 4.5
Platelets, Normal 82.0 82.7 93.3 85.7 89.7 83.6
Platelets, High 18.0 17.3 6.7 14.3 4.4 11.9
15.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Month 6.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 257 254
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 7.8 6.7
RBC, Normal 80.5 81.5
RBC, High 11.7 11.8
Neutrophils, Low 21.0 17.7
Neutrophils, Normal 79.0 81.1
Neutrophils, High 0 1.2
Lymphocytes, Low 0.4 0
Lymphocytes, Normal 97.7 97.6
Lymphocytes, High 1.9 2.4
WBC, Low 7.4 3.5
WBC, Normal 92.2 93.7
WBC, High 0.4 2.8
Haemoglobin, Low 38.1 34.3
Haemoglobin, Normal 61.9 65.7
Haemoglobin, High 0 0
Platelets, Low 0.8 0
Platelets, Normal 88.7 85.8
Platelets, High 10.5 14.2
16.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 96 89 91 68 67
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 16.0 15.6 2.2 1.1 2.9 1.5
RBC, Normal 78.0 76.0 78.7 78.0 86.8 94.0
RBC, High 6.0 8.3 19.1 20.9 10.3 4.5
Neutrophils, Low 38.0 28.1 7.9 12.1 13.2 10.4
Neutrophils, Normal 62.0 70.8 92.1 85.7 86.8 89.6
Neutrophils, High 0 1.0 0 2.2 0 0
Lymphocytes, Low 0 0 0 0 1.5 0
Lymphocytes, Normal 96.0 96.9 100.0 97.8 97.1 98.5
Lymphocytes, High 4.0 3.1 0 2.2 1.5 1.5
WBC, Low 6.0 4.2 3.4 2.2 14.7 4.5
WBC, Normal 93.0 92.7 96.6 94.5 85.3 94.0
WBC, High 1.0 3.1 0 3.3 0 1.5
Haemoglobin, Low 51.0 43.8 21.3 22.0 41.2 37.3
Haemoglobin, Normal 49.0 56.3 78.7 78.0 58.8 62.7
Haemoglobin, High 0 0 0 0 0 0
Platelets, Low 0 0 0 0 2.9 0
Platelets, Normal 89.0 87.5 87.6 85.7 89.7 83.6
Platelets, High 11.0 12.5 12.4 14.3 7.4 16.4
17.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Month 6 + 6 Days.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 253 250
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 7.5 5.6
RBC, Normal 84.6 83.6
RBC, High 7.9 10.8
Neutrophils, Low 20.9 28.8
Neutrophils, Normal 78.7 71.2
Neutrophils, High 0.4 0
Lymphocytes, Low 0 0
Lymphocytes, Normal 99.2 98.0
Lymphocytes, High 0.8 2.0
WBC, Low 4.3 7.6
WBC, Normal 94.5 90.8
WBC, High 1.2 1.6
Haemoglobin, Low 38.7 41.6
Haemoglobin, Normal 60.9 58.4
Haemoglobin, High 0.4 0
Platelets, Low 0.4 1.2
Platelets, Normal 87.4 81.6
Platelets, High 12.3 17.2
18.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Month 6 + 6 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 days time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 98 93 89 90 66 67
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 18.4 14.0 0 1.1 1.5 0
RBC, Normal 77.6 78.5 87.6 81.1 90.9 94.0
RBC, High 4.1 7.5 12.4 17.8 7.6 6.0
Neutrophils, Low 44.9 48.4 5.6 18.9 6.1 14.9
Neutrophils, Normal 55.1 51.6 93.3 81.1 93.9 85.1
Neutrophils, High 0 0 1.1 0 0 0
Lymphocytes, Low 0 0 0 0 0 0
Lymphocytes, Normal 98.0 96.8 100.0 97.8 100.0 100.0
Lymphocytes, High 2.0 3.2 0 2.2 0 0
WBC, Low 5.1 6.5 1.1 6.7 7.6 10.4
WBC, Normal 91.8 91.4 98.9 91.1 92.4 89.6
WBC, High 3.1 2.2 0 2.2 0 0
Haemoglobin, Low 56.1 51.6 19.1 27.8 39.4 46.3
Haemoglobin, Normal 43.9 48.4 80.9 72.2 59.1 53.7
Haemoglobin, High 0 0 0 0 1.5 0
Platelets, Low 0 0 0 0 1.5 4.5
Platelets, Normal 88.8 81.7 85.4 80.0 87.9 83.6
Platelets, High 11.2 18.3 14.6 20.0 10.6 11.9
19.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Month 6 + 30 Days.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 254 250
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 4.7 4.4
RBC, Normal 81.9 83.6
RBC, High 13.4 12.0
Neutrophils, Low 24.4 25.6
Neutrophils, Normal 75.6 73.2
Neutrophils, High 0 1.2
Lymphocytes, Low 0.8 0.8
Lymphocytes, Normal 98.0 98.0
Lymphocytes, High 1.2 1.2
WBC, Low 5.5 6.4
WBC, Normal 93.7 92.8
WBC, High 0.8 0.8
Haemoglobin, Low 35.0 37.6
Haemoglobin, Normal 65.0 62.0
Haemoglobin, High 0 0.4
Platelets, Low 0.4 1.6
Platelets, Normal 86.2 85.2
Platelets, High 13.4 13.2
20.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Month 6 + 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 days time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 98 93 89 90 67 67
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 9.2 11.8 2.2 0 1.5 0
RBC, Normal 76.5 74.2 82.0 86.7 89.6 92.5
RBC, High 14.3 14.0 15.7 13.3 9.0 7.5
Neutrophils, Low 52.0 57.0 10.1 8.9 3.0 4.5
Neutrophils, Normal 48.0 43.0 89.9 87.8 97.0 95.5
Neutrophils, High 0 0 0 3.3 0 0
Lymphocytes, Low 0 0 1.1 1.1 1.5 1.5
Lymphocytes, Normal 98.0 97.8 98.9 98.9 97.0 97.0
Lymphocytes, High 2.0 2.2 0 0 1.5 1.5
WBC, Low 7.1 7.5 3.4 6.7 6.0 4.5
WBC, Normal 90.8 92.5 96.6 92.2 94.0 94.0
WBC, High 2.0 0 0 1.1 0 1.5
Haemoglobin, Low 44.9 37.6 24.7 28.9 34.3 49.3
Haemoglobin, Normal 55.1 62.4 75.3 71.1 65.7 49.3
Haemoglobin, High 0 0 0 0 0 1.5
Platelets, Low 0 2.2 1.1 2.2 0 0
Platelets, Normal 84.7 86.0 86.5 87.8 88.1 80.6
Platelets, High 15.3 11.8 12.4 10.0 11.9 19.4
21.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Month 12.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 253 254
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 6.3 10.2
RBC, Normal 83.0 81.1
RBC, High 10.7 8.7
Neutrophils, Low 22.1 18.5
Neutrophils, Normal 77.9 81.5
Neutrophils, High 0 0
Lymphocytes, Low 0.4 0.8
Lymphocytes, Normal 99.2 97.6
Lymphocytes, High 0.4 1.6
WBC, Low 6.3 4.7
WBC, Normal 92.9 93.3
WBC, High 0.8 2.0
Haemoglobin, Low 42.7 46.1
Haemoglobin, Normal 56.9 53.9
Haemoglobin, High 0.4 0
Platelets, Low 0.8 1.2
Platelets, Normal 87.0 83.9
Platelets, High 12.3 15.0
22.Primary Outcome
Title Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Hide Description Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 97 88 90 65 67
Measure Type: Number
Unit of Measure: Percentage of participants
RBC, Low 13.0 23.7 3.4 0 0 4.5
RBC, Normal 74.0 64.9 86.4 88.9 92.3 94.0
RBC, High 13.0 11.3 10.2 11.1 7.7 1.5
Neutrophils, Low 47.0 40.2 2.3 6.7 10.8 3.0
Neutrophils, Normal 53.0 59.8 97.7 93.3 89.2 97.0
Neutrophils, High 0 0 0 0 0 0
Lymphocytes, Low 1.0 0 0 1.1 0 1.5
Lymphocytes, Normal 98.0 96.9 100.0 97.8 100.0 98.5
Lymphocytes, High 1.0 3.1 0 1.1 0 0
WBC, Low 5.0 8.2 3.4 2.2 12.3 3.0
WBC, Normal 93.0 86.6 96.6 97.8 87.7 97.0
WBC, High 2.0 5.2 0 0 0 0
Haemoglobin, Low 50.0 53.6 31.8 32.2 46.2 53.7
Haemoglobin, Normal 50.0 46.4 68.2 67.8 52.3 46.3
Haemoglobin, High 0 0 0 0 1.5 0
Platelets, Low 1.0 2.1 0 0 1.5 1.5
Platelets, Normal 82.0 80.4 86.4 85.6 95.4 86.6
Platelets, High 17.0 17.5 13.6 14.4 3.1 11.9
23.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Screening.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 257 258
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 24.1 29.1
ALT, Normal 75.1 70.5
ALT, High 0.8 0.4
CRE, Low 3.5 2.3
CRE, Normal 89.9 92.2
CRE, High 6.6 5.4
24.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Screening
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 100 89 91 68 67
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 24.0 35.0 27.0 27.5 20.6 22.4
ALT, Normal 76.0 65.0 70.8 71.4 79.4 77.6
ALT, High 0 0 2.2 1.1 0 0
CRE, Low 2.0 3.0 0 0 10.3 4.5
CRE, Normal 83.0 84.0 97.8 98.9 89.7 95.5
CRE, High 15.0 13.0 2.2 1.1 0 0
25.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Day 3.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 257 257
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 26.1 29.6
ALT, Normal 73.5 69.3
ALT, High 0.4 1.2
CRE, Low 1.2 1.6
CRE, Normal 93.4 90.7
CRE, High 5.4 7.8
26.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 100 89 91 68 66
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 31.0 43.0 28.1 23.1 16.2 18.2
ALT, Normal 69.0 57.0 71.9 74.7 82.4 80.3
ALT, High 0 0 0 2.2 1.5 1.5
CRE, Low 1.0 3.0 0 0 2.9 1.5
CRE, Normal 85.0 78.0 100.0 98.9 97.1 98.5
CRE, High 14.0 19.0 0 1.1 0 0
27.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Day 6.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 256 256
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 27.7 29.3
ALT, Normal 71.9 69.9
ALT, High 0.4 0.8
CRE, Low 2.7 2.0
CRE, Normal 89.5 93.4
CRE, High 7.8 4.7
28.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Day 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 99 98 89 91 68 67
Measure Type: Number
Unit of Measure: Percentage of particcipants
ALT, Low 31.3 39.8 25.8 24.2 25.0 20.9
ALT, Normal 68.7 60.2 74.2 74.7 73.5 77.6
ALT, High 0 0 0 1.1 1.5 1.5
CRE, Low 2.0 2.0 0 0 7.4 4.5
CRE, Normal 77.8 85.7 100.0 100.0 92.6 95.5
CRE, High 20.2 12.2 0 0 0 0
29.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Day 30.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 257 256
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 29.6 28.9
ALT, Normal 70.0 71.1
ALT, High 0.4 0
CRE, Low 2.3 2.0
CRE, Normal 90.3 89.5
CRE, High 7.4 8.6
30.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 98 89 91 68 67
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 30.0 40.8 33.7 29.7 23.5 10.4
ALT, Normal 70.0 59.2 65.2 70.3 76.5 89.6
ALT, High 0 0 1.1 0 0 0
CRE, Low 1.0 3.1 0 1.1 7.4 1.5
CRE, Normal 82.0 75.5 100.0 98.9 89.7 97.0
CRE, High 17.0 21.4 0 0 2.9 1.5
31.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Month 6.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 257 254
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 20.2 15.4
ALT, Normal 79.4 84.3
ALT, High 0.4 0.4
CRE, Low 14.0 13.0
CRE, Normal 84.4 86.6
CRE, High 1.6 0.4
32.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Month 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 96 89 91 68 67
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 18.0 20.8 12.4 8.8 33.8 16.4
ALT, Normal 82.0 78.1 86.5 91.2 66.2 83.6
ALT, High 0 1.0 1.1 0 0 0
CRE, Low 27.0 22.9 0 0 13.2 16.4
CRE, Normal 70.0 76.0 100.0 100.0 85.3 83.6
CRE, High 3.0 1.0 0 0 1.5 0
33.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Month 6 + 6 Days.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 253 250
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 19.8 22.4
ALT, Normal 79.1 77.6
ALT, High 1.2 0
CRE, Low 13.8 13.2
CRE, Normal 85.4 86.4
CRE, High 0.8 0.4
34.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Month 6 + 6 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 98 93 89 90 66 67
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 17.3 28.0 14.6 17.8 30.3 20.9
ALT, Normal 81.6 72.0 83.1 82.2 69.7 79.1
ALT, High 1.0 0 2.2 0 0 0
CRE, Low 26.5 29.0 2.2 0 10.6 9.0
CRE, Normal 71.4 71.0 97.8 98.9 89.4 91.0
CRE, High 2.0 0 0 1.1 0 0
35.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Month 6 + 30 Days.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 254 250
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 15.7 17.2
ALT, Normal 82.3 81.2
ALT, High 2.0 1.6
CRE, Low 15.4 15.2
CRE, Normal 83.1 83.6
CRE, High 1.6 1.2
36.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Month 6 + 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 98 93 89 90 67 67
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 14.3 17.2 10.1 13.3 25.4 22.4
ALT, Normal 82.7 82.8 87.6 83.3 74.6 76.1
ALT, High 3.1 0 2.2 3.3 0 1.5
CRE, Low 27.6 33.3 2.2 0 14.9 10.4
CRE, Normal 71.4 66.7 95.5 96.7 83.6 89.6
CRE, High 1.0 0 2.2 3.3 1.5 0
37.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Time Frame At Month 12.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 253 254
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 32.4 26.4
ALT, Normal 66.8 72.0
ALT, High 0.8 1.6
CRE, Low 15.4 15.0
CRE, Normal 77.1 79.5
CRE, High 7.5 5.5
38.Primary Outcome
Title Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
Hide Description Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
Time Frame At Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 97 88 90 65 67
Measure Type: Number
Unit of Measure: Percentage of participants
ALT, Low 26.0 27.8 39.8 25.6 32.3 25.4
ALT, Normal 73.0 71.1 59.1 74.4 67.7 70.1
ALT, High 1.0 1.0 1.1 0 0 4.5
CRE, Low 21.0 18.6 6.8 7.8 18.5 19.4
CRE, Normal 73.0 77.3 79.5 83.3 80.0 77.6
CRE, High 6.0 4.1 13.6 8.9 1.5 3.0
39.Primary Outcome
Title Number of Subjects With Adverse Events of Specific Interest (AESI), Overall
Hide Description AESI included clinical symptoms of thrombocytopenia for all subjects, in both groups.
Time Frame During the 7 day follow-up period after vaccination at Day 0 (i.e., Day 0 up to Day 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 300 300
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
40.Primary Outcome
Title Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum
Hide Description AESI included clinical symptoms of thrombocytopenia for subjects aged 1-5 years, 6-12 years and 13-17 years.
Time Frame During the 7 day follow-up period after vaccination at Day 0 (i.e. Day 0 up to Day 6)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 100 99 101 101 99
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
41.Primary Outcome
Title Number of Subjects With Serious Adverse Events, Overall
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. SAEs, for this endpoint, were assessed in all subjects, in both groups.
Time Frame During the entire study period: From Screening to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 300 300
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.7%
2
   0.7%
42.Primary Outcome
Title Number of Subjects With Serious Adverse Events, by Age Stratum
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. SAEs, for this endpoint, were assessed in subjects aged 1-5 years, 6-12 years and 13-17 years.
Time Frame During the entire study period: From Screening to Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 100 99 101 101 99
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   1.0%
1
   1.0%
1
   1.0%
1
   1.0%
0
   0.0%
43.Secondary Outcome
Title Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall
Hide Description Anti-GP EBOV antibodies were expressed as Geometric Mean Titers (GMTs), as measured by the Enzyme-Linked Immunosorbent Assay (ELISA) and assessed in all subjects, in both groups.
Time Frame At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 295 294
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-GP EBOV, Day 0 Number Analyzed 295 participants 294 participants
24.755
(22.673 to 27.029)
24.587
(22.612 to 26.735)
Anti-GP EBOV, Day 30 Number Analyzed 243 participants 238 participants
1739.756
(1562.966 to 1936.543)
24.372
(22.236 to 26.714)
Anti-GP EBOV, Month 6 Number Analyzed 240 participants 234 participants
1017.712
(925.011 to 1119.702)
23.343
(21.616 to 25.208)
Anti-GP EBOV, Month 6 + Day 30 Number Analyzed 240 participants 234 participants
970.870
(883.886 to 1066.414)
1513.928
(1370.915 to 1671.859)
Anti-GP EBOV, Month 12 Number Analyzed 238 participants 235 participants
909.092
(813.891 to 1015.429)
889.641
(800.009 to 989.315)
44.Secondary Outcome
Title Anti-GP EBOV Antibody Titers, by Age Stratum
Hide Description Anti-GP EBOV antibodies were expressed as Geometric Mean Titers (GMTs), as measured by the Enzyme-Linked Immunosorbent Assay (ELISA) and assessed in subjects aged 1-5 years, 6-12 years and 13-17 years.
Time Frame At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 100 96 98 99 96
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-GP EBOV, Day 0 Number Analyzed 100 participants 100 participants 96 participants 98 participants 99 participants 96 participants
29.526
(24.175 to 36.062)
31.545
(26.543 to 37.489)
22.764
(20.195 to 25.661)
21.241
(18.973 to 23.780)
22.473
(19.966 to 25.295)
22.021
(19.281 to 25.151)
Anti-GP EBOV, Day 30 Number Analyzed 77 participants 65 participants 82 participants 89 participants 84 participants 84 participants
1564.283
(1339.748 to 1826.449)
29.565
(24.794 to 35.254)
1394.540
(1174.847 to 1655.316)
21.879
(19.098 to 25.065)
2405.635
(1942.446 to 2979.274)
22.300
(18.991 to 26.186)
Anti-GP EBOV, Month 6 Number Analyzed 77 participants 64 participants 82 participants 89 participants 81 participants 81 participants
705.913
(619.567 to 804.292)
23.328
(20.814 to 26.146)
1030.880
(887.724 to 1197.121)
21.834
(19.476 to 24.478)
1482.304
(1231.572 to 1784.081)
25.141
(21.161 to 29.871)
Anti-GP EBOV, Month 6 + 30 Days Number Analyzed 76 participants 63 participants 82 participants 89 participants 82 participants 82 participants
722.550
(638.466 to 817.708)
1150.199
(971.093 to 1362.339)
885.295
(766.161 to 1022.954)
1399.458
(1188.609 to 1647.710)
1439.460
(1193.726 to 1735.780)
2190.763
(1862.359 to 2577.076)
Anti-GP EBOV, Month 12 Number Analyzed 77 participants 64 participants 81 participants 89 participants 80 participants 82 participants
715.890
(619.208 to 827.668)
583.371
(486.760 to 699.158)
751.765
(645.194 to 875.939)
883.668
(759.207 to 1028.533)
1424.270
(1118.513 to 1813.608)
1412.293
(1179.201 to 1691.459)
45.Secondary Outcome
Title Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall
Hide Description A seronegative subject is a subject whose titer is below the cut-off value. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value. The analysis, for this endpoint, was performed on all subjects, in both groups.
Time Frame At Day 0, Day 30, Month 6 and Month 6 + 30 Days.
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description:
Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Overall Number of Participants Analyzed 295 294
Measure Type: Number
Unit of Measure: Percentage of participants
Anti-GP EBOV, Day 0, S- Number Analyzed 295 participants 294 participants
82.7 82.3
Anti-GP EBOV, Day 0, S+ Number Analyzed 295 participants 294 participants
17.3 17.7
Anti-GP EBOV, Day 30, S- Number Analyzed 293 participants 290 participants
0.7 83.8
Anti-GP EBOV, Day 30, S+ Number Analyzed 293 participants 290 participants
99.3 16.2
Anti-GP EBOV, Month 6, S- Number Analyzed 290 participants 282 participants
0.0 84.0
Anti-GP EBOV, Month 6, S+ Number Analyzed 290 participants 282 participants
100.0 16.0
Anti-GP EBOV, Month 6 + 30 Days, S- Number Analyzed 290 participants 281 participants
0.0 0.0
Anti-GP EBOV, Month 6 + 30 Days, S+ Number Analyzed 290 participants 281 participants
100.0 100.0
46.Secondary Outcome
Title Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum
Hide Description A seronegative subject is a subject whose titer is below the cut-off value. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value. The analysis, for this endpoint, was performed on subjects aged 1-5 years, 6-12 years and 13-17 years.
Time Frame At Day 0, Day 30, Month 6 and Month 6 + 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.
Arm/Group Title GSK3390107A+Nimenrix 13-17YOA Group Nimenrix+GSK3390107A 13-17YOA Group GSK3390107A+Nimenrix 6-12YOA Group Nimenrix+GSK3390107A 6-12YOA Group GSK3390107A+Nimenrix 1-5YOA Group Nimenrix+GSK3390107A 1-5YOA Group
Hide Arm/Group Description:
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region.
Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region.
Overall Number of Participants Analyzed 100 100 96 98 99 96
Measure Type: Number
Unit of Measure: Percentage of participants
Anti-GP EBOV, Day 0, S- Number Analyzed 100 participants 100 participants 96 participants 98 participants 99 participants 96 participants
77.0 67.0 85.4 90.8 85.9 89.6
Anti-GP EBOV, Day 0, S+ Number Analyzed 100 participants 100 participants 96 participants 98 participants 99 participants 96 participants
23.0 33.0 14.6 9.2 14.1 10.4
Anti-GP EBOV, Day 30, S- Number Analyzed 99 participants 98 participants 96 participants 98 participants 98 participants 94 participants
0 70.4 0 90.8 2.0 90.4
Anti-GP EBOV, Day 30, S+ Number Analyzed 99 participants 98 participants 96 participants 98 participants 98 participants 94 participants
100.0 29.6 100.0 9.2 98.0 9.6
Anti-GP EBOV, Month 6, S- Number Analyzed 100 participants 95 participants 96 participants 98 participants 94 participants 89 participants
0 80.0 0 88.8 0 83.1
Anti-GP EBOV, Month 6, S+ Number Analyzed 100 participants 95 participants 96 participants 98 participants 94 participants 89 participants
100.0 20.0 100.0 11.2 100.0 16.9
Anti-GP EBOV, Month 6 + 30 Days, S- Number Analyzed 98 participants 93 participants 96 participants 98 participants 96 participants 90 participants
0 0 0 0 0 0
Anti-GP EBOV, Month 6 + 30 Days, S+ Number Analyzed 98 participants 93 participants 96 participants 98 participants 96 participants 90 participants
100.0 100.0 100.0 100.0 100.0 100.0
Time Frame Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from Screening up to study end at Month 12.
Adverse Event Reporting Description From Screening to Day 0, only those SAEs that were considered related to study participation or to concurrent use of GlaxoSmithKline (GSK) medication/ vaccine needed to be recorded.
 
Arm/Group Title GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Hide Arm/Group Description Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
All-Cause Mortality
GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/300 (0.33%)      0/300 (0.00%)    
Hide Serious Adverse Events
GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/300 (0.67%)      3/300 (1.00%)    
General disorders     
DEATH  1  1/300 (0.33%)  1 0/300 (0.00%)  0
Infections and infestations     
APPENDICITIS PERFORATED  1  0/300 (0.00%)  0 1/300 (0.33%)  1
HEPATITIS B  1  0/300 (0.00%)  0 1/300 (0.33%)  1
HEPATITIS D  1  0/300 (0.00%)  0 1/300 (0.33%)  1
MALARIA  1  1/300 (0.33%)  1 0/300 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK3390107A+Nimenrix Group Nimenrix+GSK3390107A Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   194/300 (64.67%)      89/300 (29.67%)    
Gastrointestinal disorders     
GASTROINTESTINAL DISORDER  1  16/300 (5.33%)  22 6/300 (2.00%)  8
General disorders     
PAIN  1  127/300 (42.33%)  189 60/300 (20.00%)  82
PYREXIA  1  95/300 (31.67%)  112 28/300 (9.33%)  37
FATIGUE  1  33/300 (11.00%)  37 6/300 (2.00%)  8
Metabolism and nutrition disorders     
DECREASED APPETITE  1  24/300 (8.00%)  32 4/300 (1.33%)  6
Nervous system disorders     
HEADACHE  1  62/300 (20.67%)  72 17/300 (5.67%)  19
SOMNOLENCE  1  26/300 (8.67%)  37 2/300 (0.67%)  2
1
Term from vocabulary, MedDRA 20.0
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
EMail: aal77632@gsk.com
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02548078    
Other Study ID Numbers: 202090
2014-004714-28 ( EudraCT Number )
First Submitted: September 10, 2015
First Posted: September 14, 2015
Results First Submitted: March 30, 2018
Results First Posted: May 3, 2018
Last Update Posted: May 3, 2018