A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT02548078
Collaborator
(none)
600
2
2
18.2
300
16.5
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and reactogenicity of a single IM dose of the GSK3390107A (ChAd3 EBO-Z) vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years, separately.
Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational GSK3390107A (ChAd3-EBO-Z) vaccine to afford at least partial protection, all children in the study will receive the investigational GSK3390107A (ChAd3 EBO-Z) vaccine. The children in the Group GSK3390107A+Nimenrix will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine at Day 0 of the study, whereas the children in the Group Nimenrix+GSK3390107A will receive Nimenrix at Day 0 (as a control). At Month 6, the children in the Group Nimenrix+GSK3390107A will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine (provided that no safety concerns are raised), whereas the children in the Group GSK3390107A+Nimenrix will receive Nimenrix.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
600 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Children in Africa
Actual Study Start Date
:
Nov 9, 2015
Actual Primary Completion Date
:
May 15, 2017
Actual Study Completion Date
:
May 15, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
A single dose administered intramuscular
Biological: Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine
A single dose administered intramuscular
|
| Experimental: 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. |
Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
A single dose administered intramuscular
Biological: Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine
A single dose administered intramuscular
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With Solicited Local Symptoms, Overall [During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)]
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.
- Number of Subjects With Solicited Local Symptoms, by Age Stratum [During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)]
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.
- Number of Subjects With Solicited General Symptoms, Overall [During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)]
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.
- Number of Subjects With Solicited General Symptoms, by Age Stratum [During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)]
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.
- Number of Subjects With Unsolicited Adverse Events (AEs), Overall [During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)]
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.
- Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum [During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [At Screening.]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [At Screening]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [At Day 3.]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [At Day 3]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [At Day 6.]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [At Day 6]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [At Day 30.]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [At Day 30]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [At Month 6.]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [At Month 6]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [At Month 6 + 6 Days.]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [At Month 6 + 6 Days]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [At Month 6 + 30 Days.]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [At Month 6 + 30 Days]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [At Month 12.]
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.
- Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [At Month 12]
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.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [At Screening.]
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [At Screening]
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.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [At Day 3.]
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [At Day 3]
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.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [At Day 6.]
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [At Day 6]
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.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [At Day 30.]
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [At Day 30]
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.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [At Month 6.]
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [At Month 6]
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.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [At Month 6 + 6 Days.]
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [At Month 6 + 6 Days]
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.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [At Month 6 + 30 Days.]
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [At Month 6 + 30 Days]
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.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [At Month 12.]
Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
- Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [At Month 12]
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.
- Number of Subjects With Adverse Events of Specific Interest (AESI), Overall [During the 7 day follow-up period after vaccination at Day 0 (i.e., Day 0 up to Day 6)]
AESI included clinical symptoms of thrombocytopenia for all subjects, in both groups.
- Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum [During the 7 day follow-up period after vaccination at Day 0 (i.e. Day 0 up to Day 6)]
AESI included clinical symptoms of thrombocytopenia for subjects aged 1-5 years, 6-12 years and 13-17 years.
- Number of Subjects With Serious Adverse Events, Overall [During the entire study period: From Screening to Month 12]
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.
- Number of Subjects With Serious Adverse Events, by Age Stratum [During the entire study period: From Screening to Month 12]
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.
Secondary Outcome Measures
- Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall [At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12.]
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.
- Anti-GP EBOV Antibody Titers, by Age Stratum [At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12]
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.
- Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall [At Day 0, Day 30, Month 6 and Month 6 + 30 Days.]
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.
- Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum [At Day 0, Day 30, Month 6 and Month 6 + 30 Days]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Subject's parent(s)/ legally acceptable representative(s) (LAR[s]) who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g. availability for Diary Card completion, return for follow-up visits, availability for clinical follow-up throughout the study period).
-
Written/ thumb printed informed consent obtained from the subject' parent(s)/ LAR[s] prior to performing any study specific procedure. In addition, written/ thumb printed in-formed assent should be obtained if appropriate (from all subjects aged 13 to 17 years and from younger subjects as per local requirements).
-
A male or female child aged 1 to 17 years inclusive at the time of Screening.
-
Subjects with a negative RDT test for Malaria within 30 days prior to randomisation into the study.
OR Subjects with a positive RDT test for Malaria who completed antimalarial treatment at least 5 days prior to randomisation into the study.
-
Healthy subjects as per Investigator judgement, as estab-lished by medical history, clinical examination and haema-tology/ biochemistry laboratory parameters screening be-fore entering into the study.
-
Female subjects of non-childbearing potential may be enrolled in the study.
-
Non-childbearing potential is defined as pre-menarche or ovariectomy.
-
Female subjects of childbearing potential may be enrolled in the study, if the subject:
-
has practiced adequate contraception for 30 days prior to the Day 0 visit, and
-
has a negative pregnancy test at the Day 0 visit, and
-
has agreed to continue adequate contraception until 30 days after the Month 6 visit
Exclusion Criteria:
-
Child in care.
-
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the Day 0 visit, or planned use during the study period.
-
Previous vaccination with an investigational EBOV or Marburg vaccine, or previous vaccination with a chim-panzee adenoviral vectored investigational vaccine.
-
Known prior EBOV or SUDV disease.
-
Travel to country affected by the EBOV epidemic or direct contact with person with EVD within 21 days prior to the Day 0 visit.
-
History of any reaction or hypersensitivity (such as ana-phylaxis, urticaria (hives), respiratory difficulty, angioe-dema, or abdominal pain) likely to be exacerbated by any component of the study vaccine.
-
Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each vaccination visit.
-
Acute or chronic illness determined by medical history, clinical examination and laboratory screening tests in-cluding, but not limited to:
-
Clinically significant immunosuppressive or immunodeficient condition (e.g. clinical acquired immune deficiency syndrome [AIDS]).
-
Major congenital defects.
-
Malnutrition (defined as weight for age Z-score less than -3, or other clinical signs of malnutrition).
-
Any clinically significant haematological or biochemical laboratory abnormality.
-
Pregnant female.
-
Any condition that in the Investigator's opinion may po-tentially compromise subject safety or interfere with sub-ject assessment or compliance.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Bamako | Mali | ||
| 2 | GSK Investigational Site | Dakar | Senegal |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02548078
Other Study ID Numbers:
- 202090
- 2014-004714-28
First Posted:
Sep 14, 2015
Last Update Posted:
May 3, 2018
Last Verified:
Mar 1, 2018
Keywords provided by GlaxoSmithKline
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Period Title: Overall Study | ||
| STARTED | 300 | 300 |
| COMPLETED | 295 | 294 |
| NOT COMPLETED | 5 | 6 |
Baseline Characteristics
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group | Total |
|---|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Total of all reporting groups |
| Overall Participants | 300 | 300 | 600 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
9.0
(4.95)
|
8.8
(5.03)
|
8.90
(4.99)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
149
49.7%
|
150
50%
|
299
49.8%
|
| Male |
151
50.3%
|
150
50%
|
301
50.2%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| AFRICAN HERITAGE/AFRICAN AMERICAN |
300
100%
|
300
100%
|
600
100%
|
Outcome Measures
| Title | Number of Subjects With Solicited Local Symptoms, Overall |
|---|---|
| Description | Assessed solicited local symptoms included: pain and swelling at the injections site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying at limb movement/spontaneous pain.Grade 3 swelling = swelling extending on a surface higher than (>) 30 millimeters (mm). Solicited local symptoms, for this endpoint, were assessed in all subjects, in both groups. |
| Time Frame | During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 300 | 300 |
| Any Pain |
127
42.3%
|
60
20%
|
| Grade 3 Pain |
4
1.3%
|
0
0%
|
| Any Swelling |
5
1.7%
|
1
0.3%
|
| Grade 3 Swelling |
1
0.3%
|
0
0%
|
| Title | Number of Subjects With Solicited Local Symptoms, by Age Stratum |
|---|---|
| Description | Assessed solicited local symptoms included: pain and swelling at the injections site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying at limb movement/spontaneous pain.Grade 3 swelling = swelling extending on a surface higher than (>) 30 millimeters (mm), for children between 1-5 years old; > 50 mm for children between 6-12 years old and >100 mm for children between 13-17 years old. |
| Time Frame | During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 100 | 99 | 101 | 101 | 99 |
| Any Pain |
31
10.3%
|
14
4.7%
|
41
6.8%
|
23
NaN
|
55
NaN
|
23
NaN
|
| Grade 3 Pain |
0
0%
|
0
0%
|
1
0.2%
|
0
NaN
|
3
NaN
|
0
NaN
|
| Any Swelling |
1
0.3%
|
0
0%
|
3
0.5%
|
1
NaN
|
1
NaN
|
0
NaN
|
| Grade 3 Swelling |
0
0%
|
0
0%
|
1
0.2%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Title | Number of Subjects With Solicited General Symptoms, Overall |
|---|---|
| Description | Solicited general symptoms assessed included: fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue/headache/drowsiness/gastrointestinal symptoms = fatigue/headache/drowsiness/gastrointestinal symptoms that prevented normal activity. Grade 3 fever = temperature > 39.5°C. Grade 3 irritability/fussiness = crying that couldn't be comforted. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. Solicited general symptoms, for this endpoint, were assessed in all subjects, in both groups. |
| Time Frame | During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 300 | 300 |
| Any Fatigue |
33
11%
|
6
2%
|
| Grade 3 Fatigue |
0
0%
|
0
0%
|
| Related Fatigue |
32
10.7%
|
5
1.7%
|
| Any Fever |
95
31.7%
|
28
9.3%
|
| Grade 3 Fever |
1
0.3%
|
0
0%
|
| Related Fever |
89
29.7%
|
26
8.7%
|
| Any Gastrointestinal symptoms |
16
5.3%
|
6
2%
|
| Grade 3 Gastrointestinal symptoms |
0
0%
|
0
0%
|
| Related Gastrointestinal symptoms |
13
4.3%
|
3
1%
|
| Any Headache |
62
20.7%
|
17
5.7%
|
| Grade 3 Headache |
0
0%
|
0
0%
|
| Related Headache |
60
20%
|
14
4.7%
|
| Any Drowsiness |
26
8.7%
|
2
0.7%
|
| Grade 3 Drowsiness |
3
1%
|
0
0%
|
| Related Drowsiness |
26
8.7%
|
1
0.3%
|
| Any Irritability/fussiness |
10
3.3%
|
2
0.7%
|
| Grade 3 Irritability/fussiness |
4
1.3%
|
0
0%
|
| Related Irritability/fussiness |
10
3.3%
|
2
0.7%
|
| Any Loss of appetite |
24
8%
|
4
1.3%
|
| Grade 3 Loss of appetite |
3
1%
|
0
0%
|
| Related Loss of appetite |
24
8%
|
4
1.3%
|
| Title | Number of Subjects With Solicited General Symptoms, by Age Stratum |
|---|---|
| Description | Solicited general symptoms assessed included: fatigue, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], gastrointestinal symptoms [nausea, vomiting, diarrhoea and/or abdominal pain], headache, drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue/headache/drowsiness/gastrointestinal symptoms = fatigue/headache/drowsiness/gastrointestinal symptoms that prevented normal activity. Grade 3 fever = temperature > 39.5°C. Grade 3 irritability/fussiness = crying that couldn't be comforted. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. Solicited general symptoms, for this endpoint, were assessed in subjects aged 1-5 years, 6-12 years and 13-17 years. Symptoms with no values were not assessed for those specific age groups. |
| Time Frame | During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 100 | 99 | 101 | 101 | 99 |
| Any Fatigue |
20
6.7%
|
5
1.7%
|
13
2.2%
|
1
NaN
|
||
| Grade 3 Fatigue |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
||
| Related Fatigue |
20
6.7%
|
4
1.3%
|
12
2%
|
1
NaN
|
||
| Any Fever |
20
6.7%
|
4
1.3%
|
25
4.2%
|
1
NaN
|
50
NaN
|
23
NaN
|
| Grade 3 Fever |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
1
NaN
|
0
NaN
|
| Related Fever |
17
5.7%
|
4
1.3%
|
23
3.8%
|
1
NaN
|
49
NaN
|
21
NaN
|
| Any Gastrointestinal symptoms |
9
3%
|
2
0.7%
|
7
1.2%
|
4
NaN
|
||
| Grade 3 Gastrointestinal symptoms |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
||
| Related Gastrointestinal symptoms |
8
2.7%
|
0
0%
|
5
0.8%
|
3
NaN
|
||
| Any Headache |
36
12%
|
11
3.7%
|
26
4.3%
|
6
NaN
|
||
| Grade 3 Headache |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
||
| Related Headache |
35
11.7%
|
8
2.7%
|
25
4.2%
|
6
NaN
|
||
| Any Drowsiness |
26
8.7%
|
2
0.7%
|
||||
| Grade 3 Drowsiness |
3
1%
|
0
0%
|
||||
| Related Drowsiness |
26
8.7%
|
1
0.3%
|
||||
| Any Irritability/fusiness |
10
3.3%
|
2
0.7%
|
||||
| Grade 3 Irritability/fusiness |
4
1.3%
|
0
0%
|
||||
| Related Irritability/fusiness |
10
3.3%
|
2
0.7%
|
||||
| Any Loss of appetite |
24
8%
|
4
1.3%
|
||||
| Grade 3 Loss of appetite |
3
1%
|
0
0%
|
||||
| Related Loss of appetite |
24
8%
|
4
1.3%
|
| Title | Number of Subjects With Unsolicited Adverse Events (AEs), Overall |
|---|---|
| Description | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited adverse events, for this endpoint, were assessed in all subjects, in both groups. |
| Time Frame | During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 300 | 300 |
| Count of Participants [Participants] |
41
13.7%
|
24
8%
|
| Title | Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum |
|---|---|
| Description | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited AEs, for this endpoint, were assessed in subjects between 1-5 years of age, 6-12 years of age and 13-17 years of age. |
| Time Frame | During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 100 | 99 | 101 | 101 | 99 |
| Count of Participants [Participants] |
12
4%
|
8
2.7%
|
6
1%
|
10
NaN
|
23
NaN
|
6
NaN
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Screening. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 257 | 258 |
| RBC, Low |
3.9
1.3%
|
2.7
0.9%
|
| RBC, Normal |
84.4
28.1%
|
81.8
27.3%
|
| RBC, High |
11.7
3.9%
|
15.5
5.2%
|
| Neutrophils, Low |
12.8
4.3%
|
10.9
3.6%
|
| Neutrophils, Normal |
86.4
28.8%
|
89.1
29.7%
|
| Neutrophils, High |
0.8
0.3%
|
0
0%
|
| Lymphocytes, Low |
1.6
0.5%
|
0
0%
|
| Lymphocytes, Normal |
97.3
32.4%
|
97.3
32.4%
|
| Lymphocytes, High |
1.2
0.4%
|
2.7
0.9%
|
| WBC, Low |
3.5
1.2%
|
1.2
0.4%
|
| WBC, Normal |
94.9
31.6%
|
97.3
32.4%
|
| WBC, High |
1.6
0.5%
|
1.6
0.5%
|
| Haemoglobin, Low |
33.5
11.2%
|
32.9
11%
|
| Haemoglobin, Normal |
66.1
22%
|
67.1
22.4%
|
| Haemoglobin, High |
0.4
0.1%
|
0
0%
|
| Platelets, Low |
1.2
0.4%
|
1.2
0.4%
|
| Platelets, Normal |
80.2
26.7%
|
77.5
25.8%
|
| Platelets, High |
18.7
6.2%
|
21.3
7.1%
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Screening |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 100 | 89 | 91 | 68 | 67 |
| RBC, Low |
7.0
2.3%
|
5.0
1.7%
|
1.1
0.2%
|
1.1
NaN
|
2.9
NaN
|
1.5
NaN
|
| RBC, Normal |
80.0
26.7%
|
81.0
27%
|
84.3
14.1%
|
78.0
NaN
|
91.2
NaN
|
88.1
NaN
|
| RBC, High |
13.0
4.3%
|
14.0
4.7%
|
14.6
2.4%
|
20.9
NaN
|
5.9
NaN
|
10.4
NaN
|
| Neutrophils, Low |
28.0
9.3%
|
20.0
6.7%
|
0
0%
|
4.4
NaN
|
7.4
NaN
|
6.0
NaN
|
| Neutrophils, Normal |
72.0
24%
|
80.0
26.7%
|
97.8
16.3%
|
95.6
NaN
|
92.6
NaN
|
94.0
NaN
|
| Neutrophils, High |
0
0%
|
0
0%
|
2.2
0.4%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Lymphocytes, Low |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
5.9
NaN
|
0
NaN
|
| Lymphocytes, Normal |
98.0
32.7%
|
95.0
31.7%
|
100.0
16.7%
|
97.8
NaN
|
92.6
NaN
|
100.0
NaN
|
| Lymphocytes, High |
2.0
0.7%
|
5.0
1.7%
|
0
0%
|
2.2
NaN
|
1.5
NaN
|
0
NaN
|
| WBC, Low |
3.0
1%
|
0
0%
|
0
0%
|
0
NaN
|
8.8
NaN
|
4.5
NaN
|
| WBC, Normal |
95.0
31.7%
|
97.0
32.3%
|
98.9
16.5%
|
98.9
NaN
|
89.7
NaN
|
95.5
NaN
|
| WBC, High |
2.0
0.7%
|
3.0
1%
|
1.1
0.2%
|
1.1
NaN
|
1.5
NaN
|
0
NaN
|
| Haemoglobin, Low |
38.0
12.7%
|
36.0
12%
|
14.6
2.4%
|
14.3
NaN
|
51.5
NaN
|
53.7
NaN
|
| Haemoglobin, Normal |
62.0
20.7%
|
64.0
21.3%
|
85.4
14.2%
|
85.7
NaN
|
47.1
NaN
|
46.3
NaN
|
| Haemoglobin, High |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
1.5
NaN
|
0
NaN
|
| Platelets, Low |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
4.4
NaN
|
4.5
NaN
|
| Platelets, Normal |
74.0
24.7%
|
71.0
23.7%
|
80.9
13.5%
|
78.0
NaN
|
88.2
NaN
|
86.6
NaN
|
| Platelets, High |
26.0
8.7%
|
29.0
9.7%
|
19.1
3.2%
|
22.0
NaN
|
7.4
NaN
|
9.0
NaN
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Day 3. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 257 | 256 |
| RBC, Low |
5.1
1.7%
|
6.3
2.1%
|
| RBC, Normal |
86.8
28.9%
|
82.4
27.5%
|
| RBC, High |
8.2
2.7%
|
11.3
3.8%
|
| Neutrophils, Low |
28.4
9.5%
|
11.7
3.9%
|
| Neutrophils, Normal |
71.2
23.7%
|
88.3
29.4%
|
| Neutrophils, High |
0.4
0.1%
|
0
0%
|
| Lymphocytes, Low |
0.8
0.3%
|
0
0%
|
| Lymphocytes, Normal |
98.4
32.8%
|
99.2
33.1%
|
| Lymphocytes, High |
0.8
0.3%
|
0.8
0.3%
|
| WBC, Low |
7.8
2.6%
|
2.3
0.8%
|
| WBC, Normal |
90.7
30.2%
|
96.1
32%
|
| WBC, High |
1.6
0.5%
|
1.6
0.5%
|
| Haemoglobin, Low |
41.2
13.7%
|
46.1
15.4%
|
| Haemoglobin, Normal |
58.8
19.6%
|
53.1
17.7%
|
| Haemoglobin, High |
0
0%
|
0.8
0.3%
|
| Platelets, Low |
0.8
0.3%
|
1.2
0.4%
|
| Platelets, Normal |
87.5
29.2%
|
82.4
27.5%
|
| Platelets, High |
11.7
3.9%
|
16.4
5.5%
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOAGroup | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 100 | 89 | 91 | 68 | 65 |
| RBC, Low |
6.0
2%
|
9.0
3%
|
2.2
0.4%
|
4.4
NaN
|
7.4
NaN
|
4.6
NaN
|
| RBC, Normal |
82.0
27.3%
|
80.0
26.7%
|
89.9
15%
|
82.4
NaN
|
89.7
NaN
|
86.2
NaN
|
| RBC, High |
12.0
4%
|
11.0
3.7%
|
7.9
1.3%
|
13.2
NaN
|
2.9
NaN
|
9.2
NaN
|
| Neutrophils, Low |
47.0
15.7%
|
22.0
7.3%
|
14.6
2.4%
|
4.4
NaN
|
19.1
NaN
|
6.2
NaN
|
| Neutrophils, Normal |
53.0
17.7%
|
78.0
26%
|
85.4
14.2%
|
95.6
NaN
|
79.4
NaN
|
93.8
NaN
|
| Neutrophils, High |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
1.5
NaN
|
0
NaN
|
| Lymphocytes, Low |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
2.9
NaN
|
0
NaN
|
| Lymphocytes, Normal |
99.0
33%
|
99.0
33%
|
100.0
16.7%
|
98.9
NaN
|
95.6
NaN
|
100.0
NaN
|
| Lymphocytes, High |
1.0
0.3%
|
1.0
0.3%
|
0
0%
|
1.1
NaN
|
1.5
NaN
|
0
NaN
|
| WBC, Low |
6.0
2%
|
2.0
0.7%
|
4.5
0.8%
|
2.2
NaN
|
14.7
NaN
|
3.1
NaN
|
| WBC, Normal |
92.0
30.7%
|
94.0
31.3%
|
95.5
15.9%
|
97.8
NaN
|
82.4
NaN
|
96.9
NaN
|
| WBC, High |
2.0
0.7%
|
4.0
1.3%
|
0
0%
|
0
NaN
|
2.9
NaN
|
0
NaN
|
| Haemoglobin, Low |
43.0
14.3%
|
44.0
14.7%
|
23.6
3.9%
|
33.0
NaN
|
61.8
NaN
|
67.7
NaN
|
| Haemoglobin, Normal |
57.0
19%
|
56.0
18.7%
|
76.4
12.7%
|
67.0
NaN
|
38.2
NaN
|
29.2
NaN
|
| Haemoglobin, High |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
3.1
NaN
|
| Platelets, Low |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
2.9
NaN
|
4.6
NaN
|
| Platelets, Normal |
79.0
26.3%
|
77.0
25.7%
|
93.3
15.6%
|
84.6
NaN
|
92.6
NaN
|
87.7
NaN
|
| Platelets, High |
21.0
7%
|
23.0
7.7%
|
6.7
1.1%
|
15.4
NaN
|
4.4
NaN
|
7.7
NaN
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Day 6. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 256 | 256 |
| RBC, Low |
7.0
2.3%
|
5.5
1.8%
|
| RBC, Normal |
83.6
27.9%
|
84.0
28%
|
| RBC, High |
9.4
3.1%
|
10.5
3.5%
|
| Neutrophils, Low |
19.9
6.6%
|
14.8
4.9%
|
| Neutrophils, Normal |
79.3
26.4%
|
84.8
28.3%
|
| Neutrophils, High |
0.8
0.3%
|
0.4
0.1%
|
| Lymphocytes, Low |
1.2
0.4%
|
0.8
0.3%
|
| Lymphocytes, Normal |
97.7
32.6%
|
97.3
32.4%
|
| Lymphocytes, High |
1.2
0.4%
|
2.0
0.7%
|
| WBC, Low |
4.7
1.6%
|
2.0
0.7%
|
| WBC, Normal |
94.1
31.4%
|
96.5
32.2%
|
| WBC, High |
1.2
0.4%
|
1.6
0.5%
|
| Haemoglobin, Low |
42.6
14.2%
|
44.1
14.7%
|
| Haemoglobin, Normal |
57.4
19.1%
|
55.1
18.4%
|
| Haemoglobin, High |
0
0%
|
0.8
0.3%
|
| Platelets, Low |
2.3
0.8%
|
2.0
0.7%
|
| Platelets, Normal |
79.7
26.6%
|
77.3
25.8%
|
| Platelets, High |
18.0
6%
|
20.7
6.9%
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Day 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 99 | 98 | 89 | 91 | 68 | 67 |
| RBC, Low |
12.1
4%
|
8.2
2.7%
|
2.2
0.4%
|
3.3
NaN
|
5.9
NaN
|
4.5
NaN
|
| RBC, Normal |
74.7
24.9%
|
82.7
27.6%
|
88.8
14.8%
|
82.4
NaN
|
89.7
NaN
|
88.1
NaN
|
| RBC, High |
13.1
4.4%
|
9.2
3.1%
|
9.0
1.5%
|
14.3
NaN
|
4.4
NaN
|
7.5
NaN
|
| Neutrophils, Low |
37.4
12.5%
|
29.6
9.9%
|
6.7
1.1%
|
6.6
NaN
|
11.8
NaN
|
4.5
NaN
|
| Neutrophils, Normal |
61.6
20.5%
|
69.4
23.1%
|
92.1
15.4%
|
93.4
NaN
|
88.2
NaN
|
95.5
NaN
|
| Neutrophils, High |
1.0
0.3%
|
1.0
0.3%
|
1.1
0.2%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Lymphocytes, Low |
1.0
0.3%
|
0
0%
|
0
0%
|
0
NaN
|
2.9
NaN
|
3.0
NaN
|
| Lymphocytes, Normal |
97.0
32.3%
|
95.9
32%
|
98.9
16.5%
|
98.9
NaN
|
97.1
NaN
|
97.0
NaN
|
| Lymphocytes, High |
2.0
0.7%
|
4.1
1.4%
|
1.1
0.2%
|
1.1
NaN
|
0
NaN
|
0
NaN
|
| WBC, Low |
5.1
1.7%
|
1.0
0.3%
|
0
0%
|
1.1
NaN
|
10.3
NaN
|
4.5
NaN
|
| WBC, Normal |
91.9
30.6%
|
94.9
31.6%
|
100.0
16.7%
|
98.9
NaN
|
89.7
NaN
|
95.5
NaN
|
| WBC, High |
3.0
1%
|
4.1
1.4%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Haemoglobin, Low |
50.5
16.8%
|
40.8
13.6%
|
22.5
3.8%
|
36.3
NaN
|
57.4
NaN
|
59.7
NaN
|
| Haemoglobin, Normal |
49.5
16.5%
|
59.2
19.7%
|
77.5
12.9%
|
63.7
NaN
|
42.6
NaN
|
37.3
NaN
|
| Haemoglobin, High |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
3.0
NaN
|
| Platelets, Low |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
8.8
NaN
|
7.5
NaN
|
| Platelets, Normal |
71.7
23.9%
|
71.4
23.8%
|
83.1
13.9%
|
80.2
NaN
|
86.8
NaN
|
82.1
NaN
|
| Platelets, High |
28.3
9.4%
|
28.6
9.5%
|
16.9
2.8%
|
19.8
NaN
|
4.4
NaN
|
10.4
NaN
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Day 30. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 257 | 256 |
| RBC, Low |
4.7
1.6%
|
3.5
1.2%
|
| RBC, Normal |
83.7
27.9%
|
82.4
27.5%
|
| RBC, High |
11.7
3.9%
|
14.1
4.7%
|
| Neutrophils, Low |
18.3
6.1%
|
15.6
5.2%
|
| Neutrophils, Normal |
80.9
27%
|
83.6
27.9%
|
| Neutrophils, High |
0.8
0.3%
|
0.8
0.3%
|
| Lymphocytes, Low |
1.9
0.6%
|
0.4
0.1%
|
| Lymphocytes, Normal |
96.1
32%
|
97.7
32.6%
|
| Lymphocytes, High |
1.9
0.6%
|
2.0
0.7%
|
| WBC, Low |
5.4
1.8%
|
3.1
1%
|
| WBC, Normal |
93.0
31%
|
95.3
31.8%
|
| WBC, High |
1.6
0.5%
|
1.6
0.5%
|
| Haemoglobin, Low |
39.7
13.2%
|
35.5
11.8%
|
| Haemoglobin, Normal |
59.5
19.8%
|
62.5
20.8%
|
| Haemoglobin, High |
0.8
0.3%
|
2.0
0.7%
|
| Platelets, Low |
1.6
0.5%
|
1.2
0.4%
|
| Platelets, Normal |
87.9
29.3%
|
84.0
28%
|
| Platelets, High |
10.5
3.5%
|
14.8
4.9%
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 98 | 89 | 91 | 68 | 67 |
| RBC, Low |
9.0
3%
|
6.1
2%
|
2.2
0.4%
|
2.2
NaN
|
1.5
NaN
|
1.5
NaN
|
| RBC, Normal |
73.0
24.3%
|
75.5
25.2%
|
88.8
14.8%
|
85.7
NaN
|
92.6
NaN
|
88.1
NaN
|
| RBC, High |
18.0
6%
|
18.4
6.1%
|
9.0
1.5%
|
12.1
NaN
|
5.9
NaN
|
10.4
NaN
|
| Neutrophils, Low |
35.0
11.7%
|
30.6
10.2%
|
11.2
1.9%
|
5.5
NaN
|
2.9
NaN
|
7.5
NaN
|
| Neutrophils, Normal |
65.0
21.7%
|
69.4
23.1%
|
87.6
14.6%
|
92.3
NaN
|
95.6
NaN
|
92.5
NaN
|
| Neutrophils, High |
0
0%
|
0
0%
|
1.1
0.2%
|
2.2
NaN
|
1.5
NaN
|
0
NaN
|
| Lymphocytes, Low |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
7.4
NaN
|
1.5
NaN
|
| Lymphocytes, Normal |
98.0
32.7%
|
96.9
32.3%
|
97.8
16.3%
|
100.0
NaN
|
91.2
NaN
|
95.5
NaN
|
| Lymphocytes, High |
2.0
0.7%
|
3.1
1%
|
2.2
0.4%
|
0
NaN
|
1.5
NaN
|
3.0
NaN
|
| WBC, Low |
5.0
1.7%
|
3.1
1%
|
4.5
0.8%
|
3.3
NaN
|
7.4
NaN
|
3.0
NaN
|
| WBC, Normal |
94.0
31.3%
|
95.9
32%
|
93.3
15.6%
|
95.6
NaN
|
91.2
NaN
|
94.0
NaN
|
| WBC, High |
1.0
0.3%
|
1.0
0.3%
|
2.2
0.4%
|
1.1
NaN
|
1.5
NaN
|
3.0
NaN
|
| Haemoglobin, Low |
37.0
12.3%
|
31.6
10.5%
|
38.2
6.4%
|
35.2
NaN
|
45.6
NaN
|
41.8
NaN
|
| Haemoglobin, Normal |
62.0
20.7%
|
67.3
22.4%
|
61.8
10.3%
|
64.8
NaN
|
52.9
NaN
|
52.2
NaN
|
| Haemoglobin, High |
1.0
0.3%
|
1.0
0.3%
|
0
0%
|
0
NaN
|
1.5
NaN
|
6.0
NaN
|
| Platelets, Low |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
5.9
NaN
|
4.5
NaN
|
| Platelets, Normal |
82.0
27.3%
|
82.7
27.6%
|
93.3
15.6%
|
85.7
NaN
|
89.7
NaN
|
83.6
NaN
|
| Platelets, High |
18.0
6%
|
17.3
5.8%
|
6.7
1.1%
|
14.3
NaN
|
4.4
NaN
|
11.9
NaN
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 6. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 257 | 254 |
| RBC, Low |
7.8
2.6%
|
6.7
2.2%
|
| RBC, Normal |
80.5
26.8%
|
81.5
27.2%
|
| RBC, High |
11.7
3.9%
|
11.8
3.9%
|
| Neutrophils, Low |
21.0
7%
|
17.7
5.9%
|
| Neutrophils, Normal |
79.0
26.3%
|
81.1
27%
|
| Neutrophils, High |
0
0%
|
1.2
0.4%
|
| Lymphocytes, Low |
0.4
0.1%
|
0
0%
|
| Lymphocytes, Normal |
97.7
32.6%
|
97.6
32.5%
|
| Lymphocytes, High |
1.9
0.6%
|
2.4
0.8%
|
| WBC, Low |
7.4
2.5%
|
3.5
1.2%
|
| WBC, Normal |
92.2
30.7%
|
93.7
31.2%
|
| WBC, High |
0.4
0.1%
|
2.8
0.9%
|
| Haemoglobin, Low |
38.1
12.7%
|
34.3
11.4%
|
| Haemoglobin, Normal |
61.9
20.6%
|
65.7
21.9%
|
| Haemoglobin, High |
0
0%
|
0
0%
|
| Platelets, Low |
0.8
0.3%
|
0
0%
|
| Platelets, Normal |
88.7
29.6%
|
85.8
28.6%
|
| Platelets, High |
10.5
3.5%
|
14.2
4.7%
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 96 | 89 | 91 | 68 | 67 |
| RBC, Low |
16.0
5.3%
|
15.6
5.2%
|
2.2
0.4%
|
1.1
NaN
|
2.9
NaN
|
1.5
NaN
|
| RBC, Normal |
78.0
26%
|
76.0
25.3%
|
78.7
13.1%
|
78.0
NaN
|
86.8
NaN
|
94.0
NaN
|
| RBC, High |
6.0
2%
|
8.3
2.8%
|
19.1
3.2%
|
20.9
NaN
|
10.3
NaN
|
4.5
NaN
|
| Neutrophils, Low |
38.0
12.7%
|
28.1
9.4%
|
7.9
1.3%
|
12.1
NaN
|
13.2
NaN
|
10.4
NaN
|
| Neutrophils, Normal |
62.0
20.7%
|
70.8
23.6%
|
92.1
15.4%
|
85.7
NaN
|
86.8
NaN
|
89.6
NaN
|
| Neutrophils, High |
0
0%
|
1.0
0.3%
|
0
0%
|
2.2
NaN
|
0
NaN
|
0
NaN
|
| Lymphocytes, Low |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
1.5
NaN
|
0
NaN
|
| Lymphocytes, Normal |
96.0
32%
|
96.9
32.3%
|
100.0
16.7%
|
97.8
NaN
|
97.1
NaN
|
98.5
NaN
|
| Lymphocytes, High |
4.0
1.3%
|
3.1
1%
|
0
0%
|
2.2
NaN
|
1.5
NaN
|
1.5
NaN
|
| WBC, Low |
6.0
2%
|
4.2
1.4%
|
3.4
0.6%
|
2.2
NaN
|
14.7
NaN
|
4.5
NaN
|
| WBC, Normal |
93.0
31%
|
92.7
30.9%
|
96.6
16.1%
|
94.5
NaN
|
85.3
NaN
|
94.0
NaN
|
| WBC, High |
1.0
0.3%
|
3.1
1%
|
0
0%
|
3.3
NaN
|
0
NaN
|
1.5
NaN
|
| Haemoglobin, Low |
51.0
17%
|
43.8
14.6%
|
21.3
3.6%
|
22.0
NaN
|
41.2
NaN
|
37.3
NaN
|
| Haemoglobin, Normal |
49.0
16.3%
|
56.3
18.8%
|
78.7
13.1%
|
78.0
NaN
|
58.8
NaN
|
62.7
NaN
|
| Haemoglobin, High |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Platelets, Low |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
2.9
NaN
|
0
NaN
|
| Platelets, Normal |
89.0
29.7%
|
87.5
29.2%
|
87.6
14.6%
|
85.7
NaN
|
89.7
NaN
|
83.6
NaN
|
| Platelets, High |
11.0
3.7%
|
12.5
4.2%
|
12.4
2.1%
|
14.3
NaN
|
7.4
NaN
|
16.4
NaN
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 6 + 6 Days. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 253 | 250 |
| RBC, Low |
7.5
2.5%
|
5.6
1.9%
|
| RBC, Normal |
84.6
28.2%
|
83.6
27.9%
|
| RBC, High |
7.9
2.6%
|
10.8
3.6%
|
| Neutrophils, Low |
20.9
7%
|
28.8
9.6%
|
| Neutrophils, Normal |
78.7
26.2%
|
71.2
23.7%
|
| Neutrophils, High |
0.4
0.1%
|
0
0%
|
| Lymphocytes, Low |
0
0%
|
0
0%
|
| Lymphocytes, Normal |
99.2
33.1%
|
98.0
32.7%
|
| Lymphocytes, High |
0.8
0.3%
|
2.0
0.7%
|
| WBC, Low |
4.3
1.4%
|
7.6
2.5%
|
| WBC, Normal |
94.5
31.5%
|
90.8
30.3%
|
| WBC, High |
1.2
0.4%
|
1.6
0.5%
|
| Haemoglobin, Low |
38.7
12.9%
|
41.6
13.9%
|
| Haemoglobin, Normal |
60.9
20.3%
|
58.4
19.5%
|
| Haemoglobin, High |
0.4
0.1%
|
0
0%
|
| Platelets, Low |
0.4
0.1%
|
1.2
0.4%
|
| Platelets, Normal |
87.4
29.1%
|
81.6
27.2%
|
| Platelets, High |
12.3
4.1%
|
17.2
5.7%
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 6 + 6 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 days time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 98 | 93 | 89 | 90 | 66 | 67 |
| RBC, Low |
18.4
6.1%
|
14.0
4.7%
|
0
0%
|
1.1
NaN
|
1.5
NaN
|
0
NaN
|
| RBC, Normal |
77.6
25.9%
|
78.5
26.2%
|
87.6
14.6%
|
81.1
NaN
|
90.9
NaN
|
94.0
NaN
|
| RBC, High |
4.1
1.4%
|
7.5
2.5%
|
12.4
2.1%
|
17.8
NaN
|
7.6
NaN
|
6.0
NaN
|
| Neutrophils, Low |
44.9
15%
|
48.4
16.1%
|
5.6
0.9%
|
18.9
NaN
|
6.1
NaN
|
14.9
NaN
|
| Neutrophils, Normal |
55.1
18.4%
|
51.6
17.2%
|
93.3
15.6%
|
81.1
NaN
|
93.9
NaN
|
85.1
NaN
|
| Neutrophils, High |
0
0%
|
0
0%
|
1.1
0.2%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Lymphocytes, Low |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Lymphocytes, Normal |
98.0
32.7%
|
96.8
32.3%
|
100.0
16.7%
|
97.8
NaN
|
100.0
NaN
|
100.0
NaN
|
| Lymphocytes, High |
2.0
0.7%
|
3.2
1.1%
|
0
0%
|
2.2
NaN
|
0
NaN
|
0
NaN
|
| WBC, Low |
5.1
1.7%
|
6.5
2.2%
|
1.1
0.2%
|
6.7
NaN
|
7.6
NaN
|
10.4
NaN
|
| WBC, Normal |
91.8
30.6%
|
91.4
30.5%
|
98.9
16.5%
|
91.1
NaN
|
92.4
NaN
|
89.6
NaN
|
| WBC, High |
3.1
1%
|
2.2
0.7%
|
0
0%
|
2.2
NaN
|
0
NaN
|
0
NaN
|
| Haemoglobin, Low |
56.1
18.7%
|
51.6
17.2%
|
19.1
3.2%
|
27.8
NaN
|
39.4
NaN
|
46.3
NaN
|
| Haemoglobin, Normal |
43.9
14.6%
|
48.4
16.1%
|
80.9
13.5%
|
72.2
NaN
|
59.1
NaN
|
53.7
NaN
|
| Haemoglobin, High |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
1.5
NaN
|
0
NaN
|
| Platelets, Low |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
1.5
NaN
|
4.5
NaN
|
| Platelets, Normal |
88.8
29.6%
|
81.7
27.2%
|
85.4
14.2%
|
80.0
NaN
|
87.9
NaN
|
83.6
NaN
|
| Platelets, High |
11.2
3.7%
|
18.3
6.1%
|
14.6
2.4%
|
20.0
NaN
|
10.6
NaN
|
11.9
NaN
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 6 + 30 Days. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 254 | 250 |
| RBC, Low |
4.7
1.6%
|
4.4
1.5%
|
| RBC, Normal |
81.9
27.3%
|
83.6
27.9%
|
| RBC, High |
13.4
4.5%
|
12.0
4%
|
| Neutrophils, Low |
24.4
8.1%
|
25.6
8.5%
|
| Neutrophils, Normal |
75.6
25.2%
|
73.2
24.4%
|
| Neutrophils, High |
0
0%
|
1.2
0.4%
|
| Lymphocytes, Low |
0.8
0.3%
|
0.8
0.3%
|
| Lymphocytes, Normal |
98.0
32.7%
|
98.0
32.7%
|
| Lymphocytes, High |
1.2
0.4%
|
1.2
0.4%
|
| WBC, Low |
5.5
1.8%
|
6.4
2.1%
|
| WBC, Normal |
93.7
31.2%
|
92.8
30.9%
|
| WBC, High |
0.8
0.3%
|
0.8
0.3%
|
| Haemoglobin, Low |
35.0
11.7%
|
37.6
12.5%
|
| Haemoglobin, Normal |
65.0
21.7%
|
62.0
20.7%
|
| Haemoglobin, High |
0
0%
|
0.4
0.1%
|
| Platelets, Low |
0.4
0.1%
|
1.6
0.5%
|
| Platelets, Normal |
86.2
28.7%
|
85.2
28.4%
|
| Platelets, High |
13.4
4.5%
|
13.2
4.4%
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 6 + 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 days time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 98 | 93 | 89 | 90 | 67 | 67 |
| RBC, Low |
9.2
3.1%
|
11.8
3.9%
|
2.2
0.4%
|
0
NaN
|
1.5
NaN
|
0
NaN
|
| RBC, Normal |
76.5
25.5%
|
74.2
24.7%
|
82.0
13.7%
|
86.7
NaN
|
89.6
NaN
|
92.5
NaN
|
| RBC, High |
14.3
4.8%
|
14.0
4.7%
|
15.7
2.6%
|
13.3
NaN
|
9.0
NaN
|
7.5
NaN
|
| Neutrophils, Low |
52.0
17.3%
|
57.0
19%
|
10.1
1.7%
|
8.9
NaN
|
3.0
NaN
|
4.5
NaN
|
| Neutrophils, Normal |
48.0
16%
|
43.0
14.3%
|
89.9
15%
|
87.8
NaN
|
97.0
NaN
|
95.5
NaN
|
| Neutrophils, High |
0
0%
|
0
0%
|
0
0%
|
3.3
NaN
|
0
NaN
|
0
NaN
|
| Lymphocytes, Low |
0
0%
|
0
0%
|
1.1
0.2%
|
1.1
NaN
|
1.5
NaN
|
1.5
NaN
|
| Lymphocytes, Normal |
98.0
32.7%
|
97.8
32.6%
|
98.9
16.5%
|
98.9
NaN
|
97.0
NaN
|
97.0
NaN
|
| Lymphocytes, High |
2.0
0.7%
|
2.2
0.7%
|
0
0%
|
0
NaN
|
1.5
NaN
|
1.5
NaN
|
| WBC, Low |
7.1
2.4%
|
7.5
2.5%
|
3.4
0.6%
|
6.7
NaN
|
6.0
NaN
|
4.5
NaN
|
| WBC, Normal |
90.8
30.3%
|
92.5
30.8%
|
96.6
16.1%
|
92.2
NaN
|
94.0
NaN
|
94.0
NaN
|
| WBC, High |
2.0
0.7%
|
0
0%
|
0
0%
|
1.1
NaN
|
0
NaN
|
1.5
NaN
|
| Haemoglobin, Low |
44.9
15%
|
37.6
12.5%
|
24.7
4.1%
|
28.9
NaN
|
34.3
NaN
|
49.3
NaN
|
| Haemoglobin, Normal |
55.1
18.4%
|
62.4
20.8%
|
75.3
12.6%
|
71.1
NaN
|
65.7
NaN
|
49.3
NaN
|
| Haemoglobin, High |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
1.5
NaN
|
| Platelets, Low |
0
0%
|
2.2
0.7%
|
1.1
0.2%
|
2.2
NaN
|
0
NaN
|
0
NaN
|
| Platelets, Normal |
84.7
28.2%
|
86.0
28.7%
|
86.5
14.4%
|
87.8
NaN
|
88.1
NaN
|
80.6
NaN
|
| Platelets, High |
15.3
5.1%
|
11.8
3.9%
|
12.4
2.1%
|
10.0
NaN
|
11.9
NaN
|
19.4
NaN
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 12. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 253 | 254 |
| RBC, Low |
6.3
2.1%
|
10.2
3.4%
|
| RBC, Normal |
83.0
27.7%
|
81.1
27%
|
| RBC, High |
10.7
3.6%
|
8.7
2.9%
|
| Neutrophils, Low |
22.1
7.4%
|
18.5
6.2%
|
| Neutrophils, Normal |
77.9
26%
|
81.5
27.2%
|
| Neutrophils, High |
0
0%
|
0
0%
|
| Lymphocytes, Low |
0.4
0.1%
|
0.8
0.3%
|
| Lymphocytes, Normal |
99.2
33.1%
|
97.6
32.5%
|
| Lymphocytes, High |
0.4
0.1%
|
1.6
0.5%
|
| WBC, Low |
6.3
2.1%
|
4.7
1.6%
|
| WBC, Normal |
92.9
31%
|
93.3
31.1%
|
| WBC, High |
0.8
0.3%
|
2.0
0.7%
|
| Haemoglobin, Low |
42.7
14.2%
|
46.1
15.4%
|
| Haemoglobin, Normal |
56.9
19%
|
53.9
18%
|
| Haemoglobin, High |
0.4
0.1%
|
0
0%
|
| Platelets, Low |
0.8
0.3%
|
1.2
0.4%
|
| Platelets, Normal |
87.0
29%
|
83.9
28%
|
| Platelets, High |
12.3
4.1%
|
15.0
5%
|
| Title | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 97 | 88 | 90 | 65 | 67 |
| RBC, Low |
13.0
4.3%
|
23.7
7.9%
|
3.4
0.6%
|
0
NaN
|
0
NaN
|
4.5
NaN
|
| RBC, Normal |
74.0
24.7%
|
64.9
21.6%
|
86.4
14.4%
|
88.9
NaN
|
92.3
NaN
|
94.0
NaN
|
| RBC, High |
13.0
4.3%
|
11.3
3.8%
|
10.2
1.7%
|
11.1
NaN
|
7.7
NaN
|
1.5
NaN
|
| Neutrophils, Low |
47.0
15.7%
|
40.2
13.4%
|
2.3
0.4%
|
6.7
NaN
|
10.8
NaN
|
3.0
NaN
|
| Neutrophils, Normal |
53.0
17.7%
|
59.8
19.9%
|
97.7
16.3%
|
93.3
NaN
|
89.2
NaN
|
97.0
NaN
|
| Neutrophils, High |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Lymphocytes, Low |
1.0
0.3%
|
0
0%
|
0
0%
|
1.1
NaN
|
0
NaN
|
1.5
NaN
|
| Lymphocytes, Normal |
98.0
32.7%
|
96.9
32.3%
|
100.0
16.7%
|
97.8
NaN
|
100.0
NaN
|
98.5
NaN
|
| Lymphocytes, High |
1.0
0.3%
|
3.1
1%
|
0
0%
|
1.1
NaN
|
0
NaN
|
0
NaN
|
| WBC, Low |
5.0
1.7%
|
8.2
2.7%
|
3.4
0.6%
|
2.2
NaN
|
12.3
NaN
|
3.0
NaN
|
| WBC, Normal |
93.0
31%
|
86.6
28.9%
|
96.6
16.1%
|
97.8
NaN
|
87.7
NaN
|
97.0
NaN
|
| WBC, High |
2.0
0.7%
|
5.2
1.7%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Haemoglobin, Low |
50.0
16.7%
|
53.6
17.9%
|
31.8
5.3%
|
32.2
NaN
|
46.2
NaN
|
53.7
NaN
|
| Haemoglobin, Normal |
50.0
16.7%
|
46.4
15.5%
|
68.2
11.4%
|
67.8
NaN
|
52.3
NaN
|
46.3
NaN
|
| Haemoglobin, High |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
1.5
NaN
|
0
NaN
|
| Platelets, Low |
1.0
0.3%
|
2.1
0.7%
|
0
0%
|
0
NaN
|
1.5
NaN
|
1.5
NaN
|
| Platelets, Normal |
82.0
27.3%
|
80.4
26.8%
|
86.4
14.4%
|
85.6
NaN
|
95.4
NaN
|
86.6
NaN
|
| Platelets, High |
17.0
5.7%
|
17.5
5.8%
|
13.6
2.3%
|
14.4
NaN
|
3.1
NaN
|
11.9
NaN
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Screening. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 257 | 258 |
| ALT, Low |
24.1
8%
|
29.1
9.7%
|
| ALT, Normal |
75.1
25%
|
70.5
23.5%
|
| ALT, High |
0.8
0.3%
|
0.4
0.1%
|
| CRE, Low |
3.5
1.2%
|
2.3
0.8%
|
| CRE, Normal |
89.9
30%
|
92.2
30.7%
|
| CRE, High |
6.6
2.2%
|
5.4
1.8%
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Screening |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 100 | 89 | 91 | 68 | 67 |
| ALT, Low |
24.0
8%
|
35.0
11.7%
|
27.0
4.5%
|
27.5
NaN
|
20.6
NaN
|
22.4
NaN
|
| ALT, Normal |
76.0
25.3%
|
65.0
21.7%
|
70.8
11.8%
|
71.4
NaN
|
79.4
NaN
|
77.6
NaN
|
| ALT, High |
0
0%
|
0
0%
|
2.2
0.4%
|
1.1
NaN
|
0
NaN
|
0
NaN
|
| CRE, Low |
2.0
0.7%
|
3.0
1%
|
0
0%
|
0
NaN
|
10.3
NaN
|
4.5
NaN
|
| CRE, Normal |
83.0
27.7%
|
84.0
28%
|
97.8
16.3%
|
98.9
NaN
|
89.7
NaN
|
95.5
NaN
|
| CRE, High |
15.0
5%
|
13.0
4.3%
|
2.2
0.4%
|
1.1
NaN
|
0
NaN
|
0
NaN
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Day 3. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 257 | 257 |
| ALT, Low |
26.1
8.7%
|
29.6
9.9%
|
| ALT, Normal |
73.5
24.5%
|
69.3
23.1%
|
| ALT, High |
0.4
0.1%
|
1.2
0.4%
|
| CRE, Low |
1.2
0.4%
|
1.6
0.5%
|
| CRE, Normal |
93.4
31.1%
|
90.7
30.2%
|
| CRE, High |
5.4
1.8%
|
7.8
2.6%
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Day 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 100 | 89 | 91 | 68 | 66 |
| ALT, Low |
31.0
10.3%
|
43.0
14.3%
|
28.1
4.7%
|
23.1
NaN
|
16.2
NaN
|
18.2
NaN
|
| ALT, Normal |
69.0
23%
|
57.0
19%
|
71.9
12%
|
74.7
NaN
|
82.4
NaN
|
80.3
NaN
|
| ALT, High |
0
0%
|
0
0%
|
0
0%
|
2.2
NaN
|
1.5
NaN
|
1.5
NaN
|
| CRE, Low |
1.0
0.3%
|
3.0
1%
|
0
0%
|
0
NaN
|
2.9
NaN
|
1.5
NaN
|
| CRE, Normal |
85.0
28.3%
|
78.0
26%
|
100.0
16.7%
|
98.9
NaN
|
97.1
NaN
|
98.5
NaN
|
| CRE, High |
14.0
4.7%
|
19.0
6.3%
|
0
0%
|
1.1
NaN
|
0
NaN
|
0
NaN
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Day 6. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 256 | 256 |
| ALT, Low |
27.7
9.2%
|
29.3
9.8%
|
| ALT, Normal |
71.9
24%
|
69.9
23.3%
|
| ALT, High |
0.4
0.1%
|
0.8
0.3%
|
| CRE, Low |
2.7
0.9%
|
2.0
0.7%
|
| CRE, Normal |
89.5
29.8%
|
93.4
31.1%
|
| CRE, High |
7.8
2.6%
|
4.7
1.6%
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Day 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 99 | 98 | 89 | 91 | 68 | 67 |
| ALT, Low |
31.3
|
39.8
|
25.8
|
24.2
|
25.0
|
20.9
|
| ALT, Normal |
68.7
|
60.2
|
74.2
|
74.7
|
73.5
|
77.6
|
| ALT, High |
0
|
0
|
0
|
1.1
|
1.5
|
1.5
|
| CRE, Low |
2.0
|
2.0
|
0
|
0
|
7.4
|
4.5
|
| CRE, Normal |
77.8
|
85.7
|
100.0
|
100.0
|
92.6
|
95.5
|
| CRE, High |
20.2
|
12.2
|
0
|
0
|
0
|
0
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Day 30. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 257 | 256 |
| ALT, Low |
29.6
9.9%
|
28.9
9.6%
|
| ALT, Normal |
70.0
23.3%
|
71.1
23.7%
|
| ALT, High |
0.4
0.1%
|
0
0%
|
| CRE, Low |
2.3
0.8%
|
2.0
0.7%
|
| CRE, Normal |
90.3
30.1%
|
89.5
29.8%
|
| CRE, High |
7.4
2.5%
|
8.6
2.9%
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Day 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 98 | 89 | 91 | 68 | 67 |
| ALT, Low |
30.0
10%
|
40.8
13.6%
|
33.7
5.6%
|
29.7
NaN
|
23.5
NaN
|
10.4
NaN
|
| ALT, Normal |
70.0
23.3%
|
59.2
19.7%
|
65.2
10.9%
|
70.3
NaN
|
76.5
NaN
|
89.6
NaN
|
| ALT, High |
0
0%
|
0
0%
|
1.1
0.2%
|
0
NaN
|
0
NaN
|
0
NaN
|
| CRE, Low |
1.0
0.3%
|
3.1
1%
|
0
0%
|
1.1
NaN
|
7.4
NaN
|
1.5
NaN
|
| CRE, Normal |
82.0
27.3%
|
75.5
25.2%
|
100.0
16.7%
|
98.9
NaN
|
89.7
NaN
|
97.0
NaN
|
| CRE, High |
17.0
5.7%
|
21.4
7.1%
|
0
0%
|
0
NaN
|
2.9
NaN
|
1.5
NaN
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 6. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 257 | 254 |
| ALT, Low |
20.2
6.7%
|
15.4
5.1%
|
| ALT, Normal |
79.4
26.5%
|
84.3
28.1%
|
| ALT, High |
0.4
0.1%
|
0.4
0.1%
|
| CRE, Low |
14.0
4.7%
|
13.0
4.3%
|
| CRE, Normal |
84.4
28.1%
|
86.6
28.9%
|
| CRE, High |
1.6
0.5%
|
0.4
0.1%
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 6 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 96 | 89 | 91 | 68 | 67 |
| ALT, Low |
18.0
6%
|
20.8
6.9%
|
12.4
2.1%
|
8.8
NaN
|
33.8
NaN
|
16.4
NaN
|
| ALT, Normal |
82.0
27.3%
|
78.1
26%
|
86.5
14.4%
|
91.2
NaN
|
66.2
NaN
|
83.6
NaN
|
| ALT, High |
0
0%
|
1.0
0.3%
|
1.1
0.2%
|
0
NaN
|
0
NaN
|
0
NaN
|
| CRE, Low |
27.0
9%
|
22.9
7.6%
|
0
0%
|
0
NaN
|
13.2
NaN
|
16.4
NaN
|
| CRE, Normal |
70.0
23.3%
|
76.0
25.3%
|
100.0
16.7%
|
100.0
NaN
|
85.3
NaN
|
83.6
NaN
|
| CRE, High |
3.0
1%
|
1.0
0.3%
|
0
0%
|
0
NaN
|
1.5
NaN
|
0
NaN
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 6 + 6 Days. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 253 | 250 |
| ALT, Low |
19.8
6.6%
|
22.4
7.5%
|
| ALT, Normal |
79.1
26.4%
|
77.6
25.9%
|
| ALT, High |
1.2
0.4%
|
0
0%
|
| CRE, Low |
13.8
4.6%
|
13.2
4.4%
|
| CRE, Normal |
85.4
28.5%
|
86.4
28.8%
|
| CRE, High |
0.8
0.3%
|
0.4
0.1%
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 6 + 6 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 98 | 93 | 89 | 90 | 66 | 67 |
| ALT, Low |
17.3
5.8%
|
28.0
9.3%
|
14.6
2.4%
|
17.8
NaN
|
30.3
NaN
|
20.9
NaN
|
| ALT, Normal |
81.6
27.2%
|
72.0
24%
|
83.1
13.9%
|
82.2
NaN
|
69.7
NaN
|
79.1
NaN
|
| ALT, High |
1.0
0.3%
|
0
0%
|
2.2
0.4%
|
0
NaN
|
0
NaN
|
0
NaN
|
| CRE, Low |
26.5
8.8%
|
29.0
9.7%
|
2.2
0.4%
|
0
NaN
|
10.6
NaN
|
9.0
NaN
|
| CRE, Normal |
71.4
23.8%
|
71.0
23.7%
|
97.8
16.3%
|
98.9
NaN
|
89.4
NaN
|
91.0
NaN
|
| CRE, High |
2.0
0.7%
|
0
0%
|
0
0%
|
1.1
NaN
|
0
NaN
|
0
NaN
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 6 + 30 Days. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 254 | 250 |
| ALT, Low |
15.7
5.2%
|
17.2
5.7%
|
| ALT, Normal |
82.3
27.4%
|
81.2
27.1%
|
| ALT, High |
2.0
0.7%
|
1.6
0.5%
|
| CRE, Low |
15.4
5.1%
|
15.2
5.1%
|
| CRE, Normal |
83.1
27.7%
|
83.6
27.9%
|
| CRE, High |
1.6
0.5%
|
1.2
0.4%
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 6 + 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 98 | 93 | 89 | 90 | 67 | 67 |
| ALT, Low |
14.3
4.8%
|
17.2
5.7%
|
10.1
1.7%
|
13.3
NaN
|
25.4
NaN
|
22.4
NaN
|
| ALT, Normal |
82.7
27.6%
|
82.8
27.6%
|
87.6
14.6%
|
83.3
NaN
|
74.6
NaN
|
76.1
NaN
|
| ALT, High |
3.1
1%
|
0
0%
|
2.2
0.4%
|
3.3
NaN
|
0
NaN
|
1.5
NaN
|
| CRE, Low |
27.6
9.2%
|
33.3
11.1%
|
2.2
0.4%
|
0
NaN
|
14.9
NaN
|
10.4
NaN
|
| CRE, Normal |
71.4
23.8%
|
66.7
22.2%
|
95.5
15.9%
|
96.7
NaN
|
83.6
NaN
|
89.6
NaN
|
| CRE, High |
1.0
0.3%
|
0
0%
|
2.2
0.4%
|
3.3
NaN
|
1.5
NaN
|
0
NaN
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 12. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 253 | 254 |
| ALT, Low |
32.4
10.8%
|
26.4
8.8%
|
| ALT, Normal |
66.8
22.3%
|
72.0
24%
|
| ALT, High |
0.8
0.3%
|
1.6
0.5%
|
| CRE, Low |
15.4
5.1%
|
15.0
5%
|
| CRE, Normal |
77.1
25.7%
|
79.5
26.5%
|
| CRE, High |
7.5
2.5%
|
5.5
1.8%
|
| Title | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
|---|---|
| Description | Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal. |
| Time Frame | At Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 97 | 88 | 90 | 65 | 67 |
| ALT, Low |
26.0
8.7%
|
27.8
9.3%
|
39.8
6.6%
|
25.6
NaN
|
32.3
NaN
|
25.4
NaN
|
| ALT, Normal |
73.0
24.3%
|
71.1
23.7%
|
59.1
9.9%
|
74.4
NaN
|
67.7
NaN
|
70.1
NaN
|
| ALT, High |
1.0
0.3%
|
1.0
0.3%
|
1.1
0.2%
|
0
NaN
|
0
NaN
|
4.5
NaN
|
| CRE, Low |
21.0
7%
|
18.6
6.2%
|
6.8
1.1%
|
7.8
NaN
|
18.5
NaN
|
19.4
NaN
|
| CRE, Normal |
73.0
24.3%
|
77.3
25.8%
|
79.5
13.3%
|
83.3
NaN
|
80.0
NaN
|
77.6
NaN
|
| CRE, High |
6.0
2%
|
4.1
1.4%
|
13.6
2.3%
|
8.9
NaN
|
1.5
NaN
|
3.0
NaN
|
| Title | Number of Subjects With Adverse Events of Specific Interest (AESI), Overall |
|---|---|
| Description | AESI included clinical symptoms of thrombocytopenia for all subjects, in both groups. |
| Time Frame | During the 7 day follow-up period after vaccination at Day 0 (i.e., Day 0 up to Day 6) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 300 | 300 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
| Title | Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum |
|---|---|
| Description | AESI included clinical symptoms of thrombocytopenia for subjects aged 1-5 years, 6-12 years and 13-17 years. |
| Time Frame | During the 7 day follow-up period after vaccination at Day 0 (i.e. Day 0 up to Day 6) |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 100 | 99 | 101 | 101 | 99 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Title | Number of Subjects With Serious Adverse Events, Overall |
|---|---|
| Description | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. SAEs, for this endpoint, were assessed in all subjects, in both groups. |
| Time Frame | During the entire study period: From Screening to Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 300 | 300 |
| Count of Participants [Participants] |
2
0.7%
|
2
0.7%
|
| Title | Number of Subjects With Serious Adverse Events, by Age Stratum |
|---|---|
| Description | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. SAEs, for this endpoint, were assessed in subjects aged 1-5 years, 6-12 years and 13-17 years. |
| Time Frame | During the entire study period: From Screening to Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 100 | 99 | 101 | 101 | 99 |
| Count of Participants [Participants] |
0
0%
|
1
0.3%
|
1
0.2%
|
1
NaN
|
1
NaN
|
0
NaN
|
| Title | Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall |
|---|---|
| Description | Anti-GP EBOV antibodies were expressed as Geometric Mean Titers (GMTs), as measured by the Enzyme-Linked Immunosorbent Assay (ELISA) and assessed in all subjects, in both groups. |
| Time Frame | At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 295 | 294 |
| Anti-GP EBOV, Day 0 |
24.755
|
24.587
|
| Anti-GP EBOV, Day 30 |
1739.756
|
24.372
|
| Anti-GP EBOV, Month 6 |
1017.712
|
23.343
|
| Anti-GP EBOV, Month 6 + Day 30 |
970.870
|
1513.928
|
| Anti-GP EBOV, Month 12 |
909.092
|
889.641
|
| Title | Anti-GP EBOV Antibody Titers, by Age Stratum |
|---|---|
| Description | Anti-GP EBOV antibodies were expressed as Geometric Mean Titers (GMTs), as measured by the Enzyme-Linked Immunosorbent Assay (ELISA) and assessed in subjects aged 1-5 years, 6-12 years and 13-17 years. |
| Time Frame | At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 100 | 96 | 98 | 99 | 96 |
| Anti-GP EBOV, Day 0 |
29.526
|
31.545
|
22.764
|
21.241
|
22.473
|
22.021
|
| Anti-GP EBOV, Day 30 |
1564.283
|
29.565
|
1394.540
|
21.879
|
2405.635
|
22.300
|
| Anti-GP EBOV, Month 6 |
705.913
|
23.328
|
1030.880
|
21.834
|
1482.304
|
25.141
|
| Anti-GP EBOV, Month 6 + 30 Days |
722.550
|
1150.199
|
885.295
|
1399.458
|
1439.460
|
2190.763
|
| Anti-GP EBOV, Month 12 |
715.890
|
583.371
|
751.765
|
883.668
|
1424.270
|
1412.293
|
| Title | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall |
|---|---|
| Description | A seronegative subject is a subject whose titer is below the cut-off value. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value. The analysis, for this endpoint, was performed on all subjects, in both groups. |
| Time Frame | At Day 0, Day 30, Month 6 and Month 6 + 30 Days. |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available. |
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group |
|---|---|---|
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. |
| Measure Participants | 295 | 294 |
| Anti-GP EBOV, Day 0, S- |
82.7
27.6%
|
82.3
27.4%
|
| Anti-GP EBOV, Day 0, S+ |
17.3
5.8%
|
17.7
5.9%
|
| Anti-GP EBOV, Day 30, S- |
0.7
0.2%
|
83.8
27.9%
|
| Anti-GP EBOV, Day 30, S+ |
99.3
33.1%
|
16.2
5.4%
|
| Anti-GP EBOV, Month 6, S- |
0.0
0%
|
84.0
28%
|
| Anti-GP EBOV, Month 6, S+ |
100.0
33.3%
|
16.0
5.3%
|
| Anti-GP EBOV, Month 6 + 30 Days, S- |
0.0
0%
|
0.0
0%
|
| Anti-GP EBOV, Month 6 + 30 Days, S+ |
100.0
33.3%
|
100.0
33.3%
|
| Title | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum |
|---|---|
| Description | A seronegative subject is a subject whose titer is below the cut-off value. A seropositive subject is a subject whose titer is greater than or equal to the cut-off value. The analysis, for this endpoint, was performed on subjects aged 1-5 years, 6-12 years and 13-17 years. |
| Time Frame | At Day 0, Day 30, Month 6 and Month 6 + 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available. |
| Arm/Group Title | GSK3390107A+Nimenrix 13-17YOA Group | Nimenrix+GSK3390107A 13-17YOA Group | GSK3390107A+Nimenrix 6-12YOA Group | Nimenrix+GSK3390107A 6-12YOA Group | GSK3390107A+Nimenrix 1-5YOA Group | Nimenrix+GSK3390107A 1-5YOA Group |
|---|---|---|---|---|---|---|
| Arm/Group Description | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 13 to 17 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 13 to 17 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 6 to 12 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 6 to 12 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the GSK3390107A+Nimenrix Group, between and including 1 to 5 years of age (YOA), who received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the thigh region. | Sub-group of subjects from the Nimenrix+GSK3390107A Group, between and including 1 to 5 years of age (YOA), who received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the thigh region. |
| Measure Participants | 100 | 100 | 96 | 98 | 99 | 96 |
| Anti-GP EBOV, Day 0, S- |
77.0
25.7%
|
67.0
22.3%
|
85.4
14.2%
|
90.8
NaN
|
85.9
NaN
|
89.6
NaN
|
| Anti-GP EBOV, Day 0, S+ |
23.0
7.7%
|
33.0
11%
|
14.6
2.4%
|
9.2
NaN
|
14.1
NaN
|
10.4
NaN
|
| Anti-GP EBOV, Day 30, S- |
0
0%
|
70.4
23.5%
|
0
0%
|
90.8
NaN
|
2.0
NaN
|
90.4
NaN
|
| Anti-GP EBOV, Day 30, S+ |
100.0
33.3%
|
29.6
9.9%
|
100.0
16.7%
|
9.2
NaN
|
98.0
NaN
|
9.6
NaN
|
| Anti-GP EBOV, Month 6, S- |
0
0%
|
80.0
26.7%
|
0
0%
|
88.8
NaN
|
0
NaN
|
83.1
NaN
|
| Anti-GP EBOV, Month 6, S+ |
100.0
33.3%
|
20.0
6.7%
|
100.0
16.7%
|
11.2
NaN
|
100.0
NaN
|
16.9
NaN
|
| Anti-GP EBOV, Month 6 + 30 Days, S- |
0
0%
|
0
0%
|
0
0%
|
0
NaN
|
0
NaN
|
0
NaN
|
| Anti-GP EBOV, Month 6 + 30 Days, S+ |
100.0
33.3%
|
100.0
33.3%
|
100.0
16.7%
|
100.0
NaN
|
100.0
NaN
|
100.0
NaN
|
Adverse Events
| Time Frame | Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from Screening up to study end at Month 12. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | From Screening to Day 0, only those SAEs that were considered related to study participation or to concurrent use of GlaxoSmithKline (GSK) medication/ vaccine needed to be recorded. | |||
| Arm/Group Title | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group | ||
| Arm/Group Description | Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | Subjects in the Nimenrix+GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children. | ||
All Cause Mortality |
||||
| GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/300 (0.3%) | 0/300 (0%) | ||
Serious Adverse Events |
||||
| GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/300 (0.7%) | 3/300 (1%) | ||
| General disorders | ||||
| DEATH | 1/300 (0.3%) | 1 | 0/300 (0%) | 0 |
| Infections and infestations | ||||
| APPENDICITIS PERFORATED | 0/300 (0%) | 0 | 1/300 (0.3%) | 1 |
| HEPATITIS B | 0/300 (0%) | 0 | 1/300 (0.3%) | 1 |
| HEPATITIS D | 0/300 (0%) | 0 | 1/300 (0.3%) | 1 |
| MALARIA | 1/300 (0.3%) | 1 | 0/300 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 194/300 (64.7%) | 89/300 (29.7%) | ||
| Gastrointestinal disorders | ||||
| GASTROINTESTINAL DISORDER | 16/300 (5.3%) | 22 | 6/300 (2%) | 8 |
| General disorders | ||||
| PAIN | 127/300 (42.3%) | 189 | 60/300 (20%) | 82 |
| PYREXIA | 95/300 (31.7%) | 112 | 28/300 (9.3%) | 37 |
| FATIGUE | 33/300 (11%) | 37 | 6/300 (2%) | 8 |
| Metabolism and nutrition disorders | ||||
| DECREASED APPETITE | 24/300 (8%) | 32 | 4/300 (1.3%) | 6 |
| Nervous system disorders | ||||
| HEADACHE | 62/300 (20.7%) | 72 | 17/300 (5.7%) | 19 |
| SOMNOLENCE | 26/300 (8.7%) | 37 | 2/300 (0.7%) | 2 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
| Name/Title | GSK Response Center |
|---|---|
| Organization | GlaxoSmithKline |
| Phone | 866-435-7343 |
| aal77632@gsk.com |
Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT02548078
Other Study ID Numbers:
- 202090
- 2014-004714-28
First Posted:
Sep 14, 2015
Last Update Posted:
May 3, 2018
Last Verified:
Mar 1, 2018