Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children (NCT NCT02548078)
NCT ID: NCT02548078
Last Updated: 2018-05-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
600 participants
Primary outcome timeframe
During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)
Results posted on
2018-05-03
Participant Flow
Participant milestones
| Measure |
GSK3390107A+Nimenrix Group
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.
|
Nimenrix+GSK3390107A Group
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 Study
STARTED
|
300
|
300
|
|
Overall Study
COMPLETED
|
295
|
294
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
GSK3390107A+Nimenrix Group
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.
|
Nimenrix+GSK3390107A Group
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 Study
Serious adverse event/Adverse event
|
1
|
0
|
|
Overall Study
Moved from study area
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children
Baseline characteristics by cohort
| Measure |
GSK3390107A+Nimenrix Group
n=300 Participants
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.
|
Nimenrix+GSK3390107A Group
n=300 Participants
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
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.0 Years
STANDARD_DEVIATION 4.95 • n=5 Participants
|
8.8 Years
STANDARD_DEVIATION 5.03 • n=7 Participants
|
8.90 Years
STANDARD_DEVIATION 4.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
299 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=5 Participants
|
150 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
AFRICAN HERITAGE/AFRICAN AMERICAN
|
300 Participants
n=5 Participants
|
300 Participants
n=7 Participants
|
600 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=300 Participants
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.
|
Nimenrix+GSK3390107A Group
n=300 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms, Overall
Any Pain
|
127 Participants
|
60 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms, Overall
Grade 3 Pain
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms, Overall
Any Swelling
|
5 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited Local Symptoms, Overall
Grade 3 Swelling
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=100 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=99 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=101 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=101 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=99 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms, by Age Stratum
Grade 3 Swelling
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms, by Age Stratum
Any Pain
|
31 Participants
|
14 Participants
|
41 Participants
|
23 Participants
|
55 Participants
|
23 Participants
|
|
Number of Subjects With Solicited Local Symptoms, by Age Stratum
Grade 3 Pain
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Local Symptoms, by Age Stratum
Any Swelling
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=300 Participants
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.
|
Nimenrix+GSK3390107A Group
n=300 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms, Overall
Any Fatigue
|
33 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Grade 3 Fatigue
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Related Fatigue
|
32 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Any Fever
|
95 Participants
|
28 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Grade 3 Fever
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Related Fever
|
89 Participants
|
26 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Any Gastrointestinal symptoms
|
16 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Grade 3 Gastrointestinal symptoms
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Related Gastrointestinal symptoms
|
13 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Any Drowsiness
|
26 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Grade 3 Drowsiness
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Any Headache
|
62 Participants
|
17 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Grade 3 Headache
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Related Headache
|
60 Participants
|
14 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Related Drowsiness
|
26 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Any Irritability/fussiness
|
10 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Grade 3 Irritability/fussiness
|
4 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Related Irritability/fussiness
|
10 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Any Loss of appetite
|
24 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Grade 3 Loss of appetite
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, Overall
Related Loss of appetite
|
24 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=100 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=99 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=101 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=101 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=99 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Grade 3 Gastrointestinal symptoms
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Related Gastrointestinal symptoms
|
8 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Any Headache
|
36 Participants
|
11 Participants
|
26 Participants
|
6 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Grade 3 Headache
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Related Headache
|
35 Participants
|
8 Participants
|
25 Participants
|
6 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Any Drowsiness
|
—
|
—
|
—
|
—
|
26 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Grade 3 Drowsiness
|
—
|
—
|
—
|
—
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Related Drowsiness
|
—
|
—
|
—
|
—
|
26 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Any Irritability/fusiness
|
—
|
—
|
—
|
—
|
10 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Grade 3 Irritability/fusiness
|
—
|
—
|
—
|
—
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Related Irritability/fusiness
|
—
|
—
|
—
|
—
|
10 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Any Loss of appetite
|
—
|
—
|
—
|
—
|
24 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Grade 3 Loss of appetite
|
—
|
—
|
—
|
—
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Related Loss of appetite
|
—
|
—
|
—
|
—
|
24 Participants
|
4 Participants
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Any Fatigue
|
20 Participants
|
5 Participants
|
13 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Grade 3 Fatigue
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Related Fatigue
|
20 Participants
|
4 Participants
|
12 Participants
|
1 Participants
|
—
|
—
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Any Fever
|
20 Participants
|
4 Participants
|
25 Participants
|
1 Participants
|
50 Participants
|
23 Participants
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Grade 3 Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Related Fever
|
17 Participants
|
4 Participants
|
23 Participants
|
1 Participants
|
49 Participants
|
21 Participants
|
|
Number of Subjects With Solicited General Symptoms, by Age Stratum
Any Gastrointestinal symptoms
|
9 Participants
|
2 Participants
|
7 Participants
|
4 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=300 Participants
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.
|
Nimenrix+GSK3390107A Group
n=300 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs), Overall
|
41 Participants
|
24 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=100 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=99 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=101 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=101 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=99 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum
|
12 Participants
|
8 Participants
|
6 Participants
|
10 Participants
|
23 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: At Screening.Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=257 Participants
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.
|
Nimenrix+GSK3390107A Group
n=258 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Low
|
3.9 Percentage of participants
|
2.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Normal
|
84.4 Percentage of participants
|
81.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, High
|
11.7 Percentage of participants
|
15.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Low
|
12.8 Percentage of participants
|
10.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Normal
|
86.4 Percentage of participants
|
89.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, High
|
0.8 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Low
|
1.6 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Normal
|
97.3 Percentage of participants
|
97.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, High
|
1.2 Percentage of participants
|
2.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Low
|
3.5 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Normal
|
94.9 Percentage of participants
|
97.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, High
|
1.6 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Low
|
33.5 Percentage of participants
|
32.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Normal
|
66.1 Percentage of participants
|
67.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, High
|
0.4 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Low
|
1.2 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Normal
|
80.2 Percentage of participants
|
77.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, High
|
18.7 Percentage of participants
|
21.3 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At ScreeningPopulation: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=100 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=91 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=68 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Normal
|
74.0 Percentage of participants
|
71.0 Percentage of participants
|
80.9 Percentage of participants
|
78.0 Percentage of participants
|
88.2 Percentage of participants
|
86.6 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Low
|
7.0 Percentage of participants
|
5.0 Percentage of participants
|
1.1 Percentage of participants
|
1.1 Percentage of participants
|
2.9 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Normal
|
80.0 Percentage of participants
|
81.0 Percentage of participants
|
84.3 Percentage of participants
|
78.0 Percentage of participants
|
91.2 Percentage of participants
|
88.1 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, High
|
13.0 Percentage of participants
|
14.0 Percentage of participants
|
14.6 Percentage of participants
|
20.9 Percentage of participants
|
5.9 Percentage of participants
|
10.4 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Low
|
28.0 Percentage of participants
|
20.0 Percentage of participants
|
0 Percentage of participants
|
4.4 Percentage of participants
|
7.4 Percentage of participants
|
6.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Normal
|
72.0 Percentage of participants
|
80.0 Percentage of participants
|
97.8 Percentage of participants
|
95.6 Percentage of participants
|
92.6 Percentage of participants
|
94.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, High
|
0 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
5.9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Normal
|
98.0 Percentage of participants
|
95.0 Percentage of participants
|
100.0 Percentage of participants
|
97.8 Percentage of participants
|
92.6 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, High
|
2.0 Percentage of participants
|
5.0 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Low
|
3.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
8.8 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Normal
|
95.0 Percentage of participants
|
97.0 Percentage of participants
|
98.9 Percentage of participants
|
98.9 Percentage of participants
|
89.7 Percentage of participants
|
95.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, High
|
2.0 Percentage of participants
|
3.0 Percentage of participants
|
1.1 Percentage of participants
|
1.1 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Low
|
38.0 Percentage of participants
|
36.0 Percentage of participants
|
14.6 Percentage of participants
|
14.3 Percentage of participants
|
51.5 Percentage of participants
|
53.7 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Normal
|
62.0 Percentage of participants
|
64.0 Percentage of participants
|
85.4 Percentage of participants
|
85.7 Percentage of participants
|
47.1 Percentage of participants
|
46.3 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, High
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.4 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, High
|
26.0 Percentage of participants
|
29.0 Percentage of participants
|
19.1 Percentage of participants
|
22.0 Percentage of participants
|
7.4 Percentage of participants
|
9.0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 3.Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=257 Participants
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.
|
Nimenrix+GSK3390107A Group
n=256 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Low
|
0.8 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Low
|
5.1 Percentage of participants
|
6.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Normal
|
86.8 Percentage of participants
|
82.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, High
|
8.2 Percentage of participants
|
11.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Low
|
28.4 Percentage of participants
|
11.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Normal
|
71.2 Percentage of participants
|
88.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, High
|
0.4 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Low
|
0.8 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Normal
|
98.4 Percentage of participants
|
99.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, High
|
0.8 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Low
|
7.8 Percentage of participants
|
2.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Normal
|
90.7 Percentage of participants
|
96.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, High
|
1.6 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Low
|
41.2 Percentage of participants
|
46.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Normal
|
58.8 Percentage of participants
|
53.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, High
|
0 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Normal
|
87.5 Percentage of participants
|
82.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, High
|
11.7 Percentage of participants
|
16.4 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 3Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=100 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=91 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=68 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=65 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Normal
|
82.0 Percentage of participants
|
80.0 Percentage of participants
|
89.9 Percentage of participants
|
82.4 Percentage of participants
|
89.7 Percentage of participants
|
86.2 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Low
|
6.0 Percentage of participants
|
9.0 Percentage of participants
|
2.2 Percentage of participants
|
4.4 Percentage of participants
|
7.4 Percentage of participants
|
4.6 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, High
|
12.0 Percentage of participants
|
11.0 Percentage of participants
|
7.9 Percentage of participants
|
13.2 Percentage of participants
|
2.9 Percentage of participants
|
9.2 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Low
|
47.0 Percentage of participants
|
22.0 Percentage of participants
|
14.6 Percentage of participants
|
4.4 Percentage of participants
|
19.1 Percentage of participants
|
6.2 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Normal
|
53.0 Percentage of participants
|
78.0 Percentage of participants
|
85.4 Percentage of participants
|
95.6 Percentage of participants
|
79.4 Percentage of participants
|
93.8 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, High
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Normal
|
99.0 Percentage of participants
|
99.0 Percentage of participants
|
100.0 Percentage of participants
|
98.9 Percentage of participants
|
95.6 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, High
|
1.0 Percentage of participants
|
1.0 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Low
|
6.0 Percentage of participants
|
2.0 Percentage of participants
|
4.5 Percentage of participants
|
2.2 Percentage of participants
|
14.7 Percentage of participants
|
3.1 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Normal
|
92.0 Percentage of participants
|
94.0 Percentage of participants
|
95.5 Percentage of participants
|
97.8 Percentage of participants
|
82.4 Percentage of participants
|
96.9 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, High
|
2.0 Percentage of participants
|
4.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Low
|
43.0 Percentage of participants
|
44.0 Percentage of participants
|
23.6 Percentage of participants
|
33.0 Percentage of participants
|
61.8 Percentage of participants
|
67.7 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Normal
|
57.0 Percentage of participants
|
56.0 Percentage of participants
|
76.4 Percentage of participants
|
67.0 Percentage of participants
|
38.2 Percentage of participants
|
29.2 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, High
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.1 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
4.6 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Normal
|
79.0 Percentage of participants
|
77.0 Percentage of participants
|
93.3 Percentage of participants
|
84.6 Percentage of participants
|
92.6 Percentage of participants
|
87.7 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, High
|
21.0 Percentage of participants
|
23.0 Percentage of participants
|
6.7 Percentage of participants
|
15.4 Percentage of participants
|
4.4 Percentage of participants
|
7.7 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 6.Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=256 Participants
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.
|
Nimenrix+GSK3390107A Group
n=256 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Low
|
7.0 Percentage of participants
|
5.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Normal
|
83.6 Percentage of participants
|
84.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, High
|
9.4 Percentage of participants
|
10.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Low
|
19.9 Percentage of participants
|
14.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Normal
|
79.3 Percentage of participants
|
84.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, High
|
0.8 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Low
|
1.2 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Normal
|
97.7 Percentage of participants
|
97.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, High
|
1.2 Percentage of participants
|
2.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Low
|
4.7 Percentage of participants
|
2.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Normal
|
94.1 Percentage of participants
|
96.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, High
|
1.2 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Low
|
42.6 Percentage of participants
|
44.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Normal
|
57.4 Percentage of participants
|
55.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, High
|
0 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Low
|
2.3 Percentage of participants
|
2.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Normal
|
79.7 Percentage of participants
|
77.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, High
|
18.0 Percentage of participants
|
20.7 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 6Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=99 Participants
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.
|
Nimenrix+GSK3390107A Group
n=98 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=91 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=68 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Low
|
12.1 Percentage of participants
|
8.2 Percentage of participants
|
2.2 Percentage of participants
|
3.3 Percentage of participants
|
5.9 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Normal
|
74.7 Percentage of participants
|
82.7 Percentage of participants
|
88.8 Percentage of participants
|
82.4 Percentage of participants
|
89.7 Percentage of participants
|
88.1 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, High
|
13.1 Percentage of participants
|
9.2 Percentage of participants
|
9.0 Percentage of participants
|
14.3 Percentage of participants
|
4.4 Percentage of participants
|
7.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Low
|
37.4 Percentage of participants
|
29.6 Percentage of participants
|
6.7 Percentage of participants
|
6.6 Percentage of participants
|
11.8 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Normal
|
61.6 Percentage of participants
|
69.4 Percentage of participants
|
92.1 Percentage of participants
|
93.4 Percentage of participants
|
88.2 Percentage of participants
|
95.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, High
|
1.0 Percentage of participants
|
1.0 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Low
|
1.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Normal
|
97.0 Percentage of participants
|
95.9 Percentage of participants
|
98.9 Percentage of participants
|
98.9 Percentage of participants
|
97.1 Percentage of participants
|
97.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, High
|
2.0 Percentage of participants
|
4.1 Percentage of participants
|
1.1 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Low
|
5.1 Percentage of participants
|
1.0 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
10.3 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Normal
|
91.9 Percentage of participants
|
94.9 Percentage of participants
|
100.0 Percentage of participants
|
98.9 Percentage of participants
|
89.7 Percentage of participants
|
95.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, High
|
3.0 Percentage of participants
|
4.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Low
|
50.5 Percentage of participants
|
40.8 Percentage of participants
|
22.5 Percentage of participants
|
36.3 Percentage of participants
|
57.4 Percentage of participants
|
59.7 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Normal
|
49.5 Percentage of participants
|
59.2 Percentage of participants
|
77.5 Percentage of participants
|
63.7 Percentage of participants
|
42.6 Percentage of participants
|
37.3 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, High
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
8.8 Percentage of participants
|
7.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Normal
|
71.7 Percentage of participants
|
71.4 Percentage of participants
|
83.1 Percentage of participants
|
80.2 Percentage of participants
|
86.8 Percentage of participants
|
82.1 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, High
|
28.3 Percentage of participants
|
28.6 Percentage of participants
|
16.9 Percentage of participants
|
19.8 Percentage of participants
|
4.4 Percentage of participants
|
10.4 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 30.Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=257 Participants
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.
|
Nimenrix+GSK3390107A Group
n=256 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Low
|
4.7 Percentage of participants
|
3.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Normal
|
83.7 Percentage of participants
|
82.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, High
|
11.7 Percentage of participants
|
14.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Low
|
18.3 Percentage of participants
|
15.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Normal
|
80.9 Percentage of participants
|
83.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, High
|
0.8 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Low
|
1.9 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Normal
|
96.1 Percentage of participants
|
97.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, High
|
1.9 Percentage of participants
|
2.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Low
|
5.4 Percentage of participants
|
3.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Normal
|
93.0 Percentage of participants
|
95.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, High
|
1.6 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Low
|
39.7 Percentage of participants
|
35.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Normal
|
59.5 Percentage of participants
|
62.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, High
|
0.8 Percentage of participants
|
2.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Low
|
1.6 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Normal
|
87.9 Percentage of participants
|
84.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, High
|
10.5 Percentage of participants
|
14.8 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 30Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=98 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=91 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=68 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Low
|
9.0 Percentage of participants
|
6.1 Percentage of participants
|
2.2 Percentage of participants
|
2.2 Percentage of participants
|
1.5 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Normal
|
73.0 Percentage of participants
|
75.5 Percentage of participants
|
88.8 Percentage of participants
|
85.7 Percentage of participants
|
92.6 Percentage of participants
|
88.1 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, High
|
18.0 Percentage of participants
|
18.4 Percentage of participants
|
9.0 Percentage of participants
|
12.1 Percentage of participants
|
5.9 Percentage of participants
|
10.4 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Low
|
35.0 Percentage of participants
|
30.6 Percentage of participants
|
11.2 Percentage of participants
|
5.5 Percentage of participants
|
2.9 Percentage of participants
|
7.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Normal
|
65.0 Percentage of participants
|
69.4 Percentage of participants
|
87.6 Percentage of participants
|
92.3 Percentage of participants
|
95.6 Percentage of participants
|
92.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, High
|
0 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
2.2 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
7.4 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Normal
|
98.0 Percentage of participants
|
96.9 Percentage of participants
|
97.8 Percentage of participants
|
100.0 Percentage of participants
|
91.2 Percentage of participants
|
95.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, High
|
2.0 Percentage of participants
|
3.1 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Low
|
5.0 Percentage of participants
|
3.1 Percentage of participants
|
4.5 Percentage of participants
|
3.3 Percentage of participants
|
7.4 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Normal
|
94.0 Percentage of participants
|
95.9 Percentage of participants
|
93.3 Percentage of participants
|
95.6 Percentage of participants
|
91.2 Percentage of participants
|
94.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, High
|
1.0 Percentage of participants
|
1.0 Percentage of participants
|
2.2 Percentage of participants
|
1.1 Percentage of participants
|
1.5 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Low
|
37.0 Percentage of participants
|
31.6 Percentage of participants
|
38.2 Percentage of participants
|
35.2 Percentage of participants
|
45.6 Percentage of participants
|
41.8 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Normal
|
62.0 Percentage of participants
|
67.3 Percentage of participants
|
61.8 Percentage of participants
|
64.8 Percentage of participants
|
52.9 Percentage of participants
|
52.2 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, High
|
1.0 Percentage of participants
|
1.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
6.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
5.9 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Normal
|
82.0 Percentage of participants
|
82.7 Percentage of participants
|
93.3 Percentage of participants
|
85.7 Percentage of participants
|
89.7 Percentage of participants
|
83.6 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, High
|
18.0 Percentage of participants
|
17.3 Percentage of participants
|
6.7 Percentage of participants
|
14.3 Percentage of participants
|
4.4 Percentage of participants
|
11.9 Percentage of participants
|
PRIMARY outcome
Timeframe: At Month 6.Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=257 Participants
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.
|
Nimenrix+GSK3390107A Group
n=254 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Low
|
7.8 Percentage of participants
|
6.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Normal
|
80.5 Percentage of participants
|
81.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, High
|
11.7 Percentage of participants
|
11.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Low
|
21.0 Percentage of participants
|
17.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Normal
|
79.0 Percentage of participants
|
81.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, High
|
0 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Low
|
0.4 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Normal
|
97.7 Percentage of participants
|
97.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, High
|
1.9 Percentage of participants
|
2.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Low
|
7.4 Percentage of participants
|
3.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Normal
|
92.2 Percentage of participants
|
93.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, High
|
0.4 Percentage of participants
|
2.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Low
|
38.1 Percentage of participants
|
34.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Normal
|
61.9 Percentage of participants
|
65.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, High
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Low
|
0.8 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Normal
|
88.7 Percentage of participants
|
85.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, High
|
10.5 Percentage of participants
|
14.2 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=96 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=91 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=68 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Low
|
16.0 Percentage of participants
|
15.6 Percentage of participants
|
2.2 Percentage of participants
|
1.1 Percentage of participants
|
2.9 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Normal
|
78.0 Percentage of participants
|
76.0 Percentage of participants
|
78.7 Percentage of participants
|
78.0 Percentage of participants
|
86.8 Percentage of participants
|
94.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, High
|
6.0 Percentage of participants
|
8.3 Percentage of participants
|
19.1 Percentage of participants
|
20.9 Percentage of participants
|
10.3 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Low
|
38.0 Percentage of participants
|
28.1 Percentage of participants
|
7.9 Percentage of participants
|
12.1 Percentage of participants
|
13.2 Percentage of participants
|
10.4 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Normal
|
62.0 Percentage of participants
|
70.8 Percentage of participants
|
92.1 Percentage of participants
|
85.7 Percentage of participants
|
86.8 Percentage of participants
|
89.6 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, High
|
0 Percentage of participants
|
1.0 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Normal
|
96.0 Percentage of participants
|
96.9 Percentage of participants
|
100.0 Percentage of participants
|
97.8 Percentage of participants
|
97.1 Percentage of participants
|
98.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, High
|
4.0 Percentage of participants
|
3.1 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
1.5 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Low
|
6.0 Percentage of participants
|
4.2 Percentage of participants
|
3.4 Percentage of participants
|
2.2 Percentage of participants
|
14.7 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Normal
|
93.0 Percentage of participants
|
92.7 Percentage of participants
|
96.6 Percentage of participants
|
94.5 Percentage of participants
|
85.3 Percentage of participants
|
94.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, High
|
1.0 Percentage of participants
|
3.1 Percentage of participants
|
0 Percentage of participants
|
3.3 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Low
|
51.0 Percentage of participants
|
43.8 Percentage of participants
|
21.3 Percentage of participants
|
22.0 Percentage of participants
|
41.2 Percentage of participants
|
37.3 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Normal
|
49.0 Percentage of participants
|
56.3 Percentage of participants
|
78.7 Percentage of participants
|
78.0 Percentage of participants
|
58.8 Percentage of participants
|
62.7 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, High
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Normal
|
89.0 Percentage of participants
|
87.5 Percentage of participants
|
87.6 Percentage of participants
|
85.7 Percentage of participants
|
89.7 Percentage of participants
|
83.6 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, High
|
11.0 Percentage of participants
|
12.5 Percentage of participants
|
12.4 Percentage of participants
|
14.3 Percentage of participants
|
7.4 Percentage of participants
|
16.4 Percentage of participants
|
PRIMARY outcome
Timeframe: At Month 6 + 6 Days.Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=253 Participants
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.
|
Nimenrix+GSK3390107A Group
n=250 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Low
|
7.5 Percentage of participants
|
5.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Normal
|
84.6 Percentage of participants
|
83.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, High
|
7.9 Percentage of participants
|
10.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Low
|
20.9 Percentage of participants
|
28.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Normal
|
78.7 Percentage of participants
|
71.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, High
|
0.4 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Normal
|
99.2 Percentage of participants
|
98.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, High
|
0.8 Percentage of participants
|
2.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Low
|
4.3 Percentage of participants
|
7.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Normal
|
94.5 Percentage of participants
|
90.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, High
|
1.2 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Low
|
38.7 Percentage of participants
|
41.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Normal
|
60.9 Percentage of participants
|
58.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, High
|
0.4 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Low
|
0.4 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Normal
|
87.4 Percentage of participants
|
81.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, High
|
12.3 Percentage of participants
|
17.2 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 6 DaysPopulation: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=98 Participants
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.
|
Nimenrix+GSK3390107A Group
n=93 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=90 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=66 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Normal
|
98.0 Percentage of participants
|
96.8 Percentage of participants
|
100.0 Percentage of participants
|
97.8 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, High
|
2.0 Percentage of participants
|
3.2 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Low
|
5.1 Percentage of participants
|
6.5 Percentage of participants
|
1.1 Percentage of participants
|
6.7 Percentage of participants
|
7.6 Percentage of participants
|
10.4 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Low
|
18.4 Percentage of participants
|
14.0 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Normal
|
77.6 Percentage of participants
|
78.5 Percentage of participants
|
87.6 Percentage of participants
|
81.1 Percentage of participants
|
90.9 Percentage of participants
|
94.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, High
|
4.1 Percentage of participants
|
7.5 Percentage of participants
|
12.4 Percentage of participants
|
17.8 Percentage of participants
|
7.6 Percentage of participants
|
6.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Low
|
44.9 Percentage of participants
|
48.4 Percentage of participants
|
5.6 Percentage of participants
|
18.9 Percentage of participants
|
6.1 Percentage of participants
|
14.9 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Normal
|
55.1 Percentage of participants
|
51.6 Percentage of participants
|
93.3 Percentage of participants
|
81.1 Percentage of participants
|
93.9 Percentage of participants
|
85.1 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, High
|
0 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Normal
|
91.8 Percentage of participants
|
91.4 Percentage of participants
|
98.9 Percentage of participants
|
91.1 Percentage of participants
|
92.4 Percentage of participants
|
89.6 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, High
|
3.1 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Low
|
56.1 Percentage of participants
|
51.6 Percentage of participants
|
19.1 Percentage of participants
|
27.8 Percentage of participants
|
39.4 Percentage of participants
|
46.3 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Normal
|
43.9 Percentage of participants
|
48.4 Percentage of participants
|
80.9 Percentage of participants
|
72.2 Percentage of participants
|
59.1 Percentage of participants
|
53.7 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, High
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Normal
|
88.8 Percentage of participants
|
81.7 Percentage of participants
|
85.4 Percentage of participants
|
80.0 Percentage of participants
|
87.9 Percentage of participants
|
83.6 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, High
|
11.2 Percentage of participants
|
18.3 Percentage of participants
|
14.6 Percentage of participants
|
20.0 Percentage of participants
|
10.6 Percentage of participants
|
11.9 Percentage of participants
|
PRIMARY outcome
Timeframe: At Month 6 + 30 Days.Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=254 Participants
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.
|
Nimenrix+GSK3390107A Group
n=250 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Low
|
4.7 Percentage of participants
|
4.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Normal
|
81.9 Percentage of participants
|
83.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, High
|
13.4 Percentage of participants
|
12.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Low
|
24.4 Percentage of participants
|
25.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Normal
|
75.6 Percentage of participants
|
73.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, High
|
0 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Low
|
0.8 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Normal
|
98.0 Percentage of participants
|
98.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, High
|
1.2 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Low
|
5.5 Percentage of participants
|
6.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Normal
|
93.7 Percentage of participants
|
92.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, High
|
0.8 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Low
|
35.0 Percentage of participants
|
37.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Normal
|
65.0 Percentage of participants
|
62.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, High
|
0 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Low
|
0.4 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Normal
|
86.2 Percentage of participants
|
85.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, High
|
13.4 Percentage of participants
|
13.2 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 30 DaysPopulation: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=98 Participants
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.
|
Nimenrix+GSK3390107A Group
n=93 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=90 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=67 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, High
|
2.0 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Low
|
9.2 Percentage of participants
|
11.8 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Normal
|
76.5 Percentage of participants
|
74.2 Percentage of participants
|
82.0 Percentage of participants
|
86.7 Percentage of participants
|
89.6 Percentage of participants
|
92.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, High
|
14.3 Percentage of participants
|
14.0 Percentage of participants
|
15.7 Percentage of participants
|
13.3 Percentage of participants
|
9.0 Percentage of participants
|
7.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Low
|
52.0 Percentage of participants
|
57.0 Percentage of participants
|
10.1 Percentage of participants
|
8.9 Percentage of participants
|
3.0 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Normal
|
48.0 Percentage of participants
|
43.0 Percentage of participants
|
89.9 Percentage of participants
|
87.8 Percentage of participants
|
97.0 Percentage of participants
|
95.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, High
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Low
|
0 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
1.1 Percentage of participants
|
1.5 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Normal
|
98.0 Percentage of participants
|
97.8 Percentage of participants
|
98.9 Percentage of participants
|
98.9 Percentage of participants
|
97.0 Percentage of participants
|
97.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Low
|
7.1 Percentage of participants
|
7.5 Percentage of participants
|
3.4 Percentage of participants
|
6.7 Percentage of participants
|
6.0 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Normal
|
90.8 Percentage of participants
|
92.5 Percentage of participants
|
96.6 Percentage of participants
|
92.2 Percentage of participants
|
94.0 Percentage of participants
|
94.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, High
|
2.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Low
|
44.9 Percentage of participants
|
37.6 Percentage of participants
|
24.7 Percentage of participants
|
28.9 Percentage of participants
|
34.3 Percentage of participants
|
49.3 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Normal
|
55.1 Percentage of participants
|
62.4 Percentage of participants
|
75.3 Percentage of participants
|
71.1 Percentage of participants
|
65.7 Percentage of participants
|
49.3 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, High
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Low
|
0 Percentage of participants
|
2.2 Percentage of participants
|
1.1 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Normal
|
84.7 Percentage of participants
|
86.0 Percentage of participants
|
86.5 Percentage of participants
|
87.8 Percentage of participants
|
88.1 Percentage of participants
|
80.6 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, High
|
15.3 Percentage of participants
|
11.8 Percentage of participants
|
12.4 Percentage of participants
|
10.0 Percentage of participants
|
11.9 Percentage of participants
|
19.4 Percentage of participants
|
PRIMARY outcome
Timeframe: At Month 12.Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=253 Participants
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.
|
Nimenrix+GSK3390107A Group
n=254 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Low
|
6.3 Percentage of participants
|
10.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, Normal
|
83.0 Percentage of participants
|
81.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
RBC, High
|
10.7 Percentage of participants
|
8.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Low
|
22.1 Percentage of participants
|
18.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, Normal
|
77.9 Percentage of participants
|
81.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Neutrophils, High
|
0 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Low
|
0.4 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, Normal
|
99.2 Percentage of participants
|
97.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Lymphocytes, High
|
0.4 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Low
|
6.3 Percentage of participants
|
4.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, Normal
|
92.9 Percentage of participants
|
93.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
WBC, High
|
0.8 Percentage of participants
|
2.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Low
|
42.7 Percentage of participants
|
46.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, Normal
|
56.9 Percentage of participants
|
53.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Haemoglobin, High
|
0.4 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Low
|
0.8 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, Normal
|
87.0 Percentage of participants
|
83.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
Platelets, High
|
12.3 Percentage of participants
|
15.0 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 12Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=97 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=88 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=90 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=65 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Low
|
13.0 Percentage of participants
|
23.7 Percentage of participants
|
3.4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, Normal
|
74.0 Percentage of participants
|
64.9 Percentage of participants
|
86.4 Percentage of participants
|
88.9 Percentage of participants
|
92.3 Percentage of participants
|
94.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
RBC, High
|
13.0 Percentage of participants
|
11.3 Percentage of participants
|
10.2 Percentage of participants
|
11.1 Percentage of participants
|
7.7 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Low
|
47.0 Percentage of participants
|
40.2 Percentage of participants
|
2.3 Percentage of participants
|
6.7 Percentage of participants
|
10.8 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, Normal
|
53.0 Percentage of participants
|
59.8 Percentage of participants
|
97.7 Percentage of participants
|
93.3 Percentage of participants
|
89.2 Percentage of participants
|
97.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Neutrophils, High
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Low
|
1.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, Normal
|
98.0 Percentage of participants
|
96.9 Percentage of participants
|
100.0 Percentage of participants
|
97.8 Percentage of participants
|
100.0 Percentage of participants
|
98.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Lymphocytes, High
|
1.0 Percentage of participants
|
3.1 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Low
|
5.0 Percentage of participants
|
8.2 Percentage of participants
|
3.4 Percentage of participants
|
2.2 Percentage of participants
|
12.3 Percentage of participants
|
3.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, Normal
|
93.0 Percentage of participants
|
86.6 Percentage of participants
|
96.6 Percentage of participants
|
97.8 Percentage of participants
|
87.7 Percentage of participants
|
97.0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
WBC, High
|
2.0 Percentage of participants
|
5.2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Low
|
50.0 Percentage of participants
|
53.6 Percentage of participants
|
31.8 Percentage of participants
|
32.2 Percentage of participants
|
46.2 Percentage of participants
|
53.7 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, Normal
|
50.0 Percentage of participants
|
46.4 Percentage of participants
|
68.2 Percentage of participants
|
67.8 Percentage of participants
|
52.3 Percentage of participants
|
46.3 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Haemoglobin, High
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Low
|
1.0 Percentage of participants
|
2.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, Normal
|
82.0 Percentage of participants
|
80.4 Percentage of participants
|
86.4 Percentage of participants
|
85.6 Percentage of participants
|
95.4 Percentage of participants
|
86.6 Percentage of participants
|
|
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
Platelets, High
|
17.0 Percentage of participants
|
17.5 Percentage of participants
|
13.6 Percentage of participants
|
14.4 Percentage of participants
|
3.1 Percentage of participants
|
11.9 Percentage of participants
|
PRIMARY outcome
Timeframe: At Screening.Population: 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.
Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=257 Participants
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.
|
Nimenrix+GSK3390107A Group
n=258 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Low
|
24.1 Percentage of participants
|
29.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Normal
|
75.1 Percentage of participants
|
70.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, High
|
0.8 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Low
|
3.5 Percentage of participants
|
2.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Normal
|
89.9 Percentage of participants
|
92.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, High
|
6.6 Percentage of participants
|
5.4 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At ScreeningPopulation: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=100 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=91 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=68 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Low
|
24.0 Percentage of participants
|
35.0 Percentage of participants
|
27.0 Percentage of participants
|
27.5 Percentage of participants
|
20.6 Percentage of participants
|
22.4 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Normal
|
76.0 Percentage of participants
|
65.0 Percentage of participants
|
70.8 Percentage of participants
|
71.4 Percentage of participants
|
79.4 Percentage of participants
|
77.6 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, High
|
0 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Low
|
2.0 Percentage of participants
|
3.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
10.3 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Normal
|
83.0 Percentage of participants
|
84.0 Percentage of participants
|
97.8 Percentage of participants
|
98.9 Percentage of participants
|
89.7 Percentage of participants
|
95.5 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, High
|
15.0 Percentage of participants
|
13.0 Percentage of participants
|
2.2 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 3.Population: 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.
Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=257 Participants
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.
|
Nimenrix+GSK3390107A Group
n=257 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Low
|
26.1 Percentage of participants
|
29.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Normal
|
73.5 Percentage of participants
|
69.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, High
|
0.4 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Low
|
1.2 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Normal
|
93.4 Percentage of participants
|
90.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, High
|
5.4 Percentage of participants
|
7.8 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 3Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=100 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=91 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=68 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=66 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Low
|
31.0 Percentage of participants
|
43.0 Percentage of participants
|
28.1 Percentage of participants
|
23.1 Percentage of participants
|
16.2 Percentage of participants
|
18.2 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Normal
|
69.0 Percentage of participants
|
57.0 Percentage of participants
|
71.9 Percentage of participants
|
74.7 Percentage of participants
|
82.4 Percentage of participants
|
80.3 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, High
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
1.5 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Low
|
1.0 Percentage of participants
|
3.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Normal
|
85.0 Percentage of participants
|
78.0 Percentage of participants
|
100.0 Percentage of participants
|
98.9 Percentage of participants
|
97.1 Percentage of participants
|
98.5 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, High
|
14.0 Percentage of participants
|
19.0 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Day 6.Population: 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.
Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=256 Participants
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.
|
Nimenrix+GSK3390107A Group
n=256 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Low
|
27.7 Percentage of participants
|
29.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Normal
|
71.9 Percentage of participants
|
69.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, High
|
0.4 Percentage of participants
|
0.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Low
|
2.7 Percentage of participants
|
2.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Normal
|
89.5 Percentage of participants
|
93.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, High
|
7.8 Percentage of participants
|
4.7 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 6Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=99 Participants
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.
|
Nimenrix+GSK3390107A Group
n=98 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=91 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=68 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Low
|
31.3 Percentage of particcipants
|
39.8 Percentage of particcipants
|
25.8 Percentage of particcipants
|
24.2 Percentage of particcipants
|
25.0 Percentage of particcipants
|
20.9 Percentage of particcipants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Normal
|
68.7 Percentage of particcipants
|
60.2 Percentage of particcipants
|
74.2 Percentage of particcipants
|
74.7 Percentage of particcipants
|
73.5 Percentage of particcipants
|
77.6 Percentage of particcipants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, High
|
0 Percentage of particcipants
|
0 Percentage of particcipants
|
0 Percentage of particcipants
|
1.1 Percentage of particcipants
|
1.5 Percentage of particcipants
|
1.5 Percentage of particcipants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Low
|
2.0 Percentage of particcipants
|
2.0 Percentage of particcipants
|
0 Percentage of particcipants
|
0 Percentage of particcipants
|
7.4 Percentage of particcipants
|
4.5 Percentage of particcipants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Normal
|
77.8 Percentage of particcipants
|
85.7 Percentage of particcipants
|
100.0 Percentage of particcipants
|
100.0 Percentage of particcipants
|
92.6 Percentage of particcipants
|
95.5 Percentage of particcipants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, High
|
20.2 Percentage of particcipants
|
12.2 Percentage of particcipants
|
0 Percentage of particcipants
|
0 Percentage of particcipants
|
0 Percentage of particcipants
|
0 Percentage of particcipants
|
PRIMARY outcome
Timeframe: At Day 30.Population: 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.
Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=257 Participants
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.
|
Nimenrix+GSK3390107A Group
n=256 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Normal
|
70.0 Percentage of participants
|
71.1 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Low
|
29.6 Percentage of participants
|
28.9 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, High
|
0.4 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Low
|
2.3 Percentage of participants
|
2.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Normal
|
90.3 Percentage of participants
|
89.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, High
|
7.4 Percentage of participants
|
8.6 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Day 30Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=98 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=91 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=68 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Low
|
30.0 Percentage of participants
|
40.8 Percentage of participants
|
33.7 Percentage of participants
|
29.7 Percentage of participants
|
23.5 Percentage of participants
|
10.4 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Normal
|
70.0 Percentage of participants
|
59.2 Percentage of participants
|
65.2 Percentage of participants
|
70.3 Percentage of participants
|
76.5 Percentage of participants
|
89.6 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, High
|
0 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Low
|
1.0 Percentage of participants
|
3.1 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
7.4 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Normal
|
82.0 Percentage of participants
|
75.5 Percentage of participants
|
100.0 Percentage of participants
|
98.9 Percentage of participants
|
89.7 Percentage of participants
|
97.0 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, High
|
17.0 Percentage of participants
|
21.4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
1.5 Percentage of participants
|
PRIMARY outcome
Timeframe: At Month 6.Population: 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.
Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=257 Participants
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.
|
Nimenrix+GSK3390107A Group
n=254 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Low
|
20.2 Percentage of participants
|
15.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Normal
|
79.4 Percentage of participants
|
84.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, High
|
0.4 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Low
|
14.0 Percentage of participants
|
13.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Normal
|
84.4 Percentage of participants
|
86.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, High
|
1.6 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=96 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=91 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=68 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Low
|
18.0 Percentage of participants
|
20.8 Percentage of participants
|
12.4 Percentage of participants
|
8.8 Percentage of participants
|
33.8 Percentage of participants
|
16.4 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Normal
|
82.0 Percentage of participants
|
78.1 Percentage of participants
|
86.5 Percentage of participants
|
91.2 Percentage of participants
|
66.2 Percentage of participants
|
83.6 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, High
|
0 Percentage of participants
|
1.0 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Low
|
27.0 Percentage of participants
|
22.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
13.2 Percentage of participants
|
16.4 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Normal
|
70.0 Percentage of participants
|
76.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
85.3 Percentage of participants
|
83.6 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, High
|
3.0 Percentage of participants
|
1.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Month 6 + 6 Days.Population: 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.
Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=253 Participants
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.
|
Nimenrix+GSK3390107A Group
n=250 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Low
|
19.8 Percentage of participants
|
22.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Normal
|
79.1 Percentage of participants
|
77.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, High
|
1.2 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Low
|
13.8 Percentage of participants
|
13.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Normal
|
85.4 Percentage of participants
|
86.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, High
|
0.8 Percentage of participants
|
0.4 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 6 DaysPopulation: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=98 Participants
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.
|
Nimenrix+GSK3390107A Group
n=93 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=90 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=66 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Low
|
17.3 Percentage of participants
|
28.0 Percentage of participants
|
14.6 Percentage of participants
|
17.8 Percentage of participants
|
30.3 Percentage of participants
|
20.9 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Normal
|
81.6 Percentage of participants
|
72.0 Percentage of participants
|
83.1 Percentage of participants
|
82.2 Percentage of participants
|
69.7 Percentage of participants
|
79.1 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, High
|
1.0 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Low
|
26.5 Percentage of participants
|
29.0 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
10.6 Percentage of participants
|
9.0 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Normal
|
71.4 Percentage of participants
|
71.0 Percentage of participants
|
97.8 Percentage of participants
|
98.9 Percentage of participants
|
89.4 Percentage of participants
|
91.0 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, High
|
2.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Month 6 + 30 Days.Population: 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.
Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=254 Participants
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.
|
Nimenrix+GSK3390107A Group
n=250 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Low
|
15.7 Percentage of participants
|
17.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Normal
|
82.3 Percentage of participants
|
81.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, High
|
2.0 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Low
|
15.4 Percentage of participants
|
15.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Normal
|
83.1 Percentage of participants
|
83.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, High
|
1.6 Percentage of participants
|
1.2 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 6 + 30 DaysPopulation: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=98 Participants
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.
|
Nimenrix+GSK3390107A Group
n=93 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=89 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=90 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=67 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Low
|
14.3 Percentage of participants
|
17.2 Percentage of participants
|
10.1 Percentage of participants
|
13.3 Percentage of participants
|
25.4 Percentage of participants
|
22.4 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Normal
|
82.7 Percentage of participants
|
82.8 Percentage of participants
|
87.6 Percentage of participants
|
83.3 Percentage of participants
|
74.6 Percentage of participants
|
76.1 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, High
|
3.1 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
3.3 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Low
|
27.6 Percentage of participants
|
33.3 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
14.9 Percentage of participants
|
10.4 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Normal
|
71.4 Percentage of participants
|
66.7 Percentage of participants
|
95.5 Percentage of participants
|
96.7 Percentage of participants
|
83.6 Percentage of participants
|
89.6 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, High
|
1.0 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
3.3 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
PRIMARY outcome
Timeframe: At Month 12.Population: 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.
Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=253 Participants
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.
|
Nimenrix+GSK3390107A Group
n=254 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Low
|
32.4 Percentage of participants
|
26.4 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, Normal
|
66.8 Percentage of participants
|
72.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
ALT, High
|
0.8 Percentage of participants
|
1.6 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Low
|
15.4 Percentage of participants
|
15.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, Normal
|
77.1 Percentage of participants
|
79.5 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
CRE, High
|
7.5 Percentage of participants
|
5.5 Percentage of participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 12Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=97 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=88 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=90 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=65 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=67 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Low
|
26.0 Percentage of participants
|
27.8 Percentage of participants
|
39.8 Percentage of participants
|
25.6 Percentage of participants
|
32.3 Percentage of participants
|
25.4 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, Normal
|
73.0 Percentage of participants
|
71.1 Percentage of participants
|
59.1 Percentage of participants
|
74.4 Percentage of participants
|
67.7 Percentage of participants
|
70.1 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
ALT, High
|
1.0 Percentage of participants
|
1.0 Percentage of participants
|
1.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.5 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Low
|
21.0 Percentage of participants
|
18.6 Percentage of participants
|
6.8 Percentage of participants
|
7.8 Percentage of participants
|
18.5 Percentage of participants
|
19.4 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, Normal
|
73.0 Percentage of participants
|
77.3 Percentage of participants
|
79.5 Percentage of participants
|
83.3 Percentage of participants
|
80.0 Percentage of participants
|
77.6 Percentage of participants
|
|
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
CRE, High
|
6.0 Percentage of participants
|
4.1 Percentage of participants
|
13.6 Percentage of participants
|
8.9 Percentage of participants
|
1.5 Percentage of participants
|
3.0 Percentage of participants
|
PRIMARY outcome
Timeframe: During the 7 day follow-up period after vaccination at Day 0 (i.e., Day 0 up to Day 6)Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
AESI included clinical symptoms of thrombocytopenia for all subjects, in both groups.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=300 Participants
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.
|
Nimenrix+GSK3390107A Group
n=300 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events of Specific Interest (AESI), Overall
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During the 7 day follow-up period after vaccination at Day 0 (i.e. Day 0 up to Day 6)Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
AESI included clinical symptoms of thrombocytopenia for subjects aged 1-5 years, 6-12 years and 13-17 years.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=100 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=99 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=101 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=101 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=99 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: During the entire study period: From Screening to Month 12Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=300 Participants
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.
|
Nimenrix+GSK3390107A Group
n=300 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events, Overall
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During the entire study period: From Screening to Month 12Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=100 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=99 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=101 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=101 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=99 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Subjects With Serious Adverse Events, by Age Stratum
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12.Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=295 Participants
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.
|
Nimenrix+GSK3390107A Group
n=294 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall
Anti-GP EBOV, Day 0
|
24.755 Titers
Interval 22.673 to 27.029
|
24.587 Titers
Interval 22.612 to 26.735
|
—
|
—
|
—
|
—
|
|
Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall
Anti-GP EBOV, Day 30
|
1739.756 Titers
Interval 1562.966 to 1936.543
|
24.372 Titers
Interval 22.236 to 26.714
|
—
|
—
|
—
|
—
|
|
Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall
Anti-GP EBOV, Month 6
|
1017.712 Titers
Interval 925.011 to 1119.702
|
23.343 Titers
Interval 21.616 to 25.208
|
—
|
—
|
—
|
—
|
|
Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall
Anti-GP EBOV, Month 6 + Day 30
|
970.870 Titers
Interval 883.886 to 1066.414
|
1513.928 Titers
Interval 1370.915 to 1671.859
|
—
|
—
|
—
|
—
|
|
Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall
Anti-GP EBOV, Month 12
|
909.092 Titers
Interval 813.891 to 1015.429
|
889.641 Titers
Interval 800.009 to 989.315
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=100 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=96 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=98 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=99 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=96 Participants
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.
|
|---|---|---|---|---|---|---|
|
Anti-GP EBOV Antibody Titers, by Age Stratum
Anti-GP EBOV, Day 0
|
29.526 Titers
Interval 24.175 to 36.062
|
31.545 Titers
Interval 26.543 to 37.489
|
22.764 Titers
Interval 20.195 to 25.661
|
21.241 Titers
Interval 18.973 to 23.78
|
22.473 Titers
Interval 19.966 to 25.295
|
22.021 Titers
Interval 19.281 to 25.151
|
|
Anti-GP EBOV Antibody Titers, by Age Stratum
Anti-GP EBOV, Day 30
|
1564.283 Titers
Interval 1339.748 to 1826.449
|
29.565 Titers
Interval 24.794 to 35.254
|
1394.540 Titers
Interval 1174.847 to 1655.316
|
21.879 Titers
Interval 19.098 to 25.065
|
2405.635 Titers
Interval 1942.446 to 2979.274
|
22.300 Titers
Interval 18.991 to 26.186
|
|
Anti-GP EBOV Antibody Titers, by Age Stratum
Anti-GP EBOV, Month 6
|
705.913 Titers
Interval 619.567 to 804.292
|
23.328 Titers
Interval 20.814 to 26.146
|
1030.880 Titers
Interval 887.724 to 1197.121
|
21.834 Titers
Interval 19.476 to 24.478
|
1482.304 Titers
Interval 1231.572 to 1784.081
|
25.141 Titers
Interval 21.161 to 29.871
|
|
Anti-GP EBOV Antibody Titers, by Age Stratum
Anti-GP EBOV, Month 6 + 30 Days
|
722.550 Titers
Interval 638.466 to 817.708
|
1150.199 Titers
Interval 971.093 to 1362.339
|
885.295 Titers
Interval 766.161 to 1022.954
|
1399.458 Titers
Interval 1188.609 to 1647.71
|
1439.460 Titers
Interval 1193.726 to 1735.78
|
2190.763 Titers
Interval 1862.359 to 2577.076
|
|
Anti-GP EBOV Antibody Titers, by Age Stratum
Anti-GP EBOV, Month 12
|
715.890 Titers
Interval 619.208 to 827.668
|
583.371 Titers
Interval 486.76 to 699.158
|
751.765 Titers
Interval 645.194 to 875.939
|
883.668 Titers
Interval 759.207 to 1028.533
|
1424.270 Titers
Interval 1118.513 to 1813.608
|
1412.293 Titers
Interval 1179.201 to 1691.459
|
SECONDARY outcome
Timeframe: At Day 0, Day 30, Month 6 and Month 6 + 30 Days.Population: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=295 Participants
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.
|
Nimenrix+GSK3390107A Group
n=294 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall
Anti-GP EBOV, Day 0, S-
|
82.7 Percentage of participants
|
82.3 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall
Anti-GP EBOV, Day 0, S+
|
17.3 Percentage of participants
|
17.7 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall
Anti-GP EBOV, Day 30, S-
|
0.7 Percentage of participants
|
83.8 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall
Anti-GP EBOV, Day 30, S+
|
99.3 Percentage of participants
|
16.2 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall
Anti-GP EBOV, Month 6, S-
|
0.0 Percentage of participants
|
84.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall
Anti-GP EBOV, Month 6, S+
|
100.0 Percentage of participants
|
16.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall
Anti-GP EBOV, Month 6 + 30 Days, S-
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall
Anti-GP EBOV, Month 6 + 30 Days, S+
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 0, Day 30, Month 6 and Month 6 + 30 DaysPopulation: 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.
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.
Outcome measures
| Measure |
GSK3390107A+Nimenrix Group
n=100 Participants
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.
|
Nimenrix+GSK3390107A Group
n=100 Participants
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.
|
GSK3390107A+Nimenrix 6-12YOA Group
n=96 Participants
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.
|
Nimenrix+GSK3390107A 6-12YOA Group
n=98 Participants
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.
|
GSK3390107A+Nimenrix 1-5YOA Group
n=99 Participants
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.
|
Nimenrix+GSK3390107A 1-5YOA Group
n=96 Participants
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.
|
|---|---|---|---|---|---|---|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum
Anti-GP EBOV, Day 0, S-
|
77.0 Percentage of participants
|
67.0 Percentage of participants
|
85.4 Percentage of participants
|
90.8 Percentage of participants
|
85.9 Percentage of participants
|
89.6 Percentage of participants
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum
Anti-GP EBOV, Day 0, S+
|
23.0 Percentage of participants
|
33.0 Percentage of participants
|
14.6 Percentage of participants
|
9.2 Percentage of participants
|
14.1 Percentage of participants
|
10.4 Percentage of participants
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum
Anti-GP EBOV, Day 30, S-
|
0 Percentage of participants
|
70.4 Percentage of participants
|
0 Percentage of participants
|
90.8 Percentage of participants
|
2.0 Percentage of participants
|
90.4 Percentage of participants
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum
Anti-GP EBOV, Day 30, S+
|
100.0 Percentage of participants
|
29.6 Percentage of participants
|
100.0 Percentage of participants
|
9.2 Percentage of participants
|
98.0 Percentage of participants
|
9.6 Percentage of participants
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum
Anti-GP EBOV, Month 6, S-
|
0 Percentage of participants
|
80.0 Percentage of participants
|
0 Percentage of participants
|
88.8 Percentage of participants
|
0 Percentage of participants
|
83.1 Percentage of participants
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum
Anti-GP EBOV, Month 6, S+
|
100.0 Percentage of participants
|
20.0 Percentage of participants
|
100.0 Percentage of participants
|
11.2 Percentage of participants
|
100.0 Percentage of participants
|
16.9 Percentage of participants
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum
Anti-GP EBOV, Month 6 + 30 Days, S-
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum
Anti-GP EBOV, Month 6 + 30 Days, S+
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
100.0 Percentage of participants
|
Adverse Events
GSK3390107A+Nimenrix Group
Serious events: 2 serious events
Other events: 194 other events
Deaths: 1 deaths
Nimenrix+GSK3390107A Group
Serious events: 3 serious events
Other events: 89 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK3390107A+Nimenrix Group
n=300 participants at risk
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.
|
Nimenrix+GSK3390107A Group
n=300 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.00%
0/300 • 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.
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.
|
0.33%
1/300 • Number of events 1 • 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.
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.
|
|
General disorders
DEATH
|
0.33%
1/300 • Number of events 1 • 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.
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.
|
0.00%
0/300 • 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.
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.
|
|
Infections and infestations
HEPATITIS B
|
0.00%
0/300 • 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.
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.
|
0.33%
1/300 • Number of events 1 • 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.
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.
|
|
Infections and infestations
HEPATITIS D
|
0.00%
0/300 • 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.
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.
|
0.33%
1/300 • Number of events 1 • 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.
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.
|
|
Infections and infestations
MALARIA
|
0.33%
1/300 • Number of events 1 • 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.
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.
|
0.00%
0/300 • 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.
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.
|
Other adverse events
| Measure |
GSK3390107A+Nimenrix Group
n=300 participants at risk
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.
|
Nimenrix+GSK3390107A Group
n=300 participants at risk
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.
|
|---|---|---|
|
General disorders
PAIN
|
42.3%
127/300 • Number of events 189 • 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.
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.
|
20.0%
60/300 • Number of events 82 • 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.
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.
|
|
General disorders
PYREXIA
|
31.7%
95/300 • Number of events 112 • 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.
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.
|
9.3%
28/300 • Number of events 37 • 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.
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.
|
|
General disorders
FATIGUE
|
11.0%
33/300 • Number of events 37 • 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.
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.
|
2.0%
6/300 • Number of events 8 • 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.
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.
|
|
Nervous system disorders
HEADACHE
|
20.7%
62/300 • Number of events 72 • 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.
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.
|
5.7%
17/300 • Number of events 19 • 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.
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.
|
|
Nervous system disorders
SOMNOLENCE
|
8.7%
26/300 • Number of events 37 • 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.
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.
|
0.67%
2/300 • Number of events 2 • 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.
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.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
8.0%
24/300 • Number of events 32 • 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.
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.
|
1.3%
4/300 • Number of events 6 • 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.
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.
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
5.3%
16/300 • Number of events 22 • 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.
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.
|
2.0%
6/300 • Number of events 8 • 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.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER