Virus Diseases
Conditions
Keywords
Protection against Ebola Zaire virus
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.
Interventions
A single dose administered intramuscular
BIOLOGICALNimenrix 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
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Mali, Senegal
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 300 |
| 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. | 300 |
| Total | 600 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
| Overall Study | Moved from study area | 3 | 3 |
| Overall Study | Serious adverse event/Adverse event | 1 | 0 |
Baseline characteristics
| Characteristic | GSK3390107A+Nimenrix Group | Nimenrix+GSK3390107A Group | Total |
|---|---|---|---|
| Age, Continuous | 9.0 Years STANDARD_DEVIATION 4.95 | 8.8 Years STANDARD_DEVIATION 5.03 | 8.90 Years STANDARD_DEVIATION 4.99 |
| Race/Ethnicity, Customized AFRICAN HERITAGE/AFRICAN AMERICAN | 300 Participants | 300 Participants | 600 Participants |
| Sex: Female, Male Female | 149 Participants | 150 Participants | 299 Participants |
| Sex: Female, Male Male | 151 Participants | 150 Participants | 301 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 300 | 0 / 300 |
| other Total, other adverse events | 194 / 300 | 89 / 300 |
| serious Total, serious adverse events | 2 / 300 | 3 / 300 |
Outcome results
Primary
Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum
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)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3390107A+Nimenrix Group | Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum | 0 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum | 0 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum | 0 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum | 0 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum | 0 Participants |
Primary
Number of Subjects With Adverse Events of Specific Interest (AESI), Overall
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)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3390107A+Nimenrix Group | Number of Subjects With Adverse Events of Specific Interest (AESI), Overall | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Adverse Events of Specific Interest (AESI), Overall | 0 Participants |
Primary
Number of Subjects With Serious Adverse Events, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3390107A+Nimenrix Group | Number of Subjects With Serious Adverse Events, by Age Stratum | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Serious Adverse Events, by Age Stratum | 1 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Serious Adverse Events, by Age Stratum | 1 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Serious Adverse Events, by Age Stratum | 1 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Serious Adverse Events, by Age Stratum | 1 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Serious Adverse Events, by Age Stratum | 0 Participants |
Primary
Number of Subjects With Serious Adverse Events, Overall
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3390107A+Nimenrix Group | Number of Subjects With Serious Adverse Events, Overall | 2 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Serious Adverse Events, Overall | 2 Participants |
Primary
Number of Subjects With Solicited General Symptoms, by Age Stratum
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)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Gastrointestinal symptoms | 0 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Fever | 20 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Gastrointestinal symptoms | 8 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Headache | 35 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Fatigue | 0 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Fever | 0 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Headache | 36 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Fatigue | 20 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Gastrointestinal symptoms | 9 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Fatigue | 20 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Headache | 0 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Fever | 17 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Gastrointestinal symptoms | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Gastrointestinal symptoms | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Fatigue | 4 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Headache | 11 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Fatigue | 5 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Fever | 4 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Headache | 8 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Fever | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Fatigue | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Fever | 4 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Headache | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Gastrointestinal symptoms | 2 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Fatigue | 12 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Fatigue | 13 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Fever | 23 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Fatigue | 0 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Gastrointestinal symptoms | 5 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Fever | 0 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Headache | 26 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Headache | 25 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Gastrointestinal symptoms | 0 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Gastrointestinal symptoms | 7 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Fever | 25 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Headache | 0 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Headache | 6 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Fatigue | 1 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Fatigue | 0 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Fatigue | 1 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Fever | 1 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Fever | 0 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Fever | 1 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Gastrointestinal symptoms | 4 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Gastrointestinal symptoms | 0 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Gastrointestinal symptoms | 3 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Headache | 0 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Headache | 6 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Fever | 49 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Loss of appetite | 24 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Fever | 1 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Fever | 50 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Drowsiness | 26 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Drowsiness | 3 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Drowsiness | 26 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Irritability/fusiness | 10 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Irritability/fusiness | 4 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Irritability/fusiness | 10 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Loss of appetite | 24 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Loss of appetite | 3 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Loss of appetite | 4 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Irritability/fusiness | 2 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Fever | 0 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Fever | 23 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Irritability/fusiness | 0 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Loss of appetite | 4 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Loss of appetite | 0 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Any Drowsiness | 2 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Irritability/fusiness | 2 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Grade 3 Drowsiness | 0 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Fever | 21 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited General Symptoms, by Age Stratum | Related Drowsiness | 1 Participants |
Primary
Number of Subjects With Solicited General Symptoms, Overall
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)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Any Fatigue | 33 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Fatigue | 0 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Related Fatigue | 32 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Any Fever | 95 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Fever | 1 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Related Fever | 89 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Any Gastrointestinal symptoms | 16 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Gastrointestinal symptoms | 0 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Related Gastrointestinal symptoms | 13 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Any Headache | 62 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Headache | 0 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Related Headache | 60 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Any Drowsiness | 26 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Drowsiness | 3 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Related Drowsiness | 26 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Any Irritability/fussiness | 10 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Irritability/fussiness | 4 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Related Irritability/fussiness | 10 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Any Loss of appetite | 24 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Loss of appetite | 3 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited General Symptoms, Overall | Related Loss of appetite | 24 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Headache | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Any Fatigue | 6 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Any Loss of appetite | 4 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Fatigue | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Related Headache | 14 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Related Fatigue | 5 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Irritability/fussiness | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Any Fever | 28 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Any Drowsiness | 2 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Fever | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Related Loss of appetite | 4 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Related Fever | 26 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Drowsiness | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Any Gastrointestinal symptoms | 6 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Related Irritability/fussiness | 2 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Gastrointestinal symptoms | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Related Drowsiness | 1 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Related Gastrointestinal symptoms | 3 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Grade 3 Loss of appetite | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Any Headache | 17 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited General Symptoms, Overall | Any Irritability/fussiness | 2 Participants |
Primary
Number of Subjects With Solicited Local Symptoms, by Age Stratum
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)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Any Pain | 31 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Grade 3 Pain | 0 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Any Swelling | 1 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Grade 3 Swelling | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Any Swelling | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Grade 3 Pain | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Any Pain | 14 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Grade 3 Swelling | 0 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Grade 3 Swelling | 1 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Any Swelling | 3 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Grade 3 Pain | 1 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Any Pain | 41 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Any Pain | 23 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Grade 3 Swelling | 0 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Grade 3 Pain | 0 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Any Swelling | 1 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Any Swelling | 1 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Grade 3 Swelling | 0 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Grade 3 Pain | 3 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Any Pain | 55 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Grade 3 Pain | 0 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Any Swelling | 0 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Grade 3 Swelling | 0 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Solicited Local Symptoms, by Age Stratum | Any Pain | 23 Participants |
Primary
Number of Subjects With Solicited Local Symptoms, Overall
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)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited Local Symptoms, Overall | Any Pain | 127 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited Local Symptoms, Overall | Grade 3 Pain | 4 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited Local Symptoms, Overall | Any Swelling | 5 Participants |
| GSK3390107A+Nimenrix Group | Number of Subjects With Solicited Local Symptoms, Overall | Grade 3 Swelling | 1 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited Local Symptoms, Overall | Grade 3 Swelling | 0 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited Local Symptoms, Overall | Any Pain | 60 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited Local Symptoms, Overall | Any Swelling | 1 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Solicited Local Symptoms, Overall | Grade 3 Pain | 0 Participants |
Primary
Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum
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)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3390107A+Nimenrix Group | Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum | 12 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum | 8 Participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum | 6 Participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum | 10 Participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum | 23 Participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum | 6 Participants |
Primary
Number of Subjects With Unsolicited Adverse Events (AEs), Overall
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)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK3390107A+Nimenrix Group | Number of Subjects With Unsolicited Adverse Events (AEs), Overall | 41 Participants |
| Nimenrix+GSK3390107A Group | Number of Subjects With Unsolicited Adverse Events (AEs), Overall | 24 Participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 71.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 82.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 1.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 27.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 3.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 14.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 33.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 82.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 66.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 17.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 95.5 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 87.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 10.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 13.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 96.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 3.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 83.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 3.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 14.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 25.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 74.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 83.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 10.4 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 76.1 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 22.4 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 89.6 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 24.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 76.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 2.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 83.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 15.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 65.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 3.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 13.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 35.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 84.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 97.8 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 27.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 70.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 71.4 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 98.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 27.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 20.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 89.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 79.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 10.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 95.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 77.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 22.4 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 31.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 69.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 1.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 85.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 14.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 57.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 3.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 19.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 43.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 78.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 28.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 71.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 74.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 98.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 23.1 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 16.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 97.1 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 82.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 2.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 98.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 80.3 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 18.2 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 31.3 Percentage of particcipants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 68.7 Percentage of particcipants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of particcipants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 2.0 Percentage of particcipants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 77.8 Percentage of particcipants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 20.2 Percentage of particcipants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 60.2 Percentage of particcipants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 2.0 Percentage of particcipants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 12.2 Percentage of particcipants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 39.8 Percentage of particcipants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of particcipants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 85.7 Percentage of particcipants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of particcipants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 100.0 Percentage of particcipants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 0 Percentage of particcipants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of particcipants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 25.8 Percentage of particcipants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 74.2 Percentage of particcipants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 0 Percentage of particcipants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 74.7 Percentage of particcipants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.1 Percentage of particcipants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of particcipants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 100.0 Percentage of particcipants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 24.2 Percentage of particcipants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 25.0 Percentage of particcipants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 92.6 Percentage of particcipants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 73.5 Percentage of particcipants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.5 Percentage of particcipants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 7.4 Percentage of particcipants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of particcipants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 4.5 Percentage of particcipants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.5 Percentage of particcipants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 95.5 Percentage of particcipants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of particcipants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 77.6 Percentage of particcipants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 20.9 Percentage of particcipants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 30.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 70.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 1.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 82.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 17.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 59.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 3.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 21.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 40.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 75.5 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 33.7 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 65.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 70.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 98.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 29.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 23.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 89.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 76.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 7.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 2.9 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 97.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 89.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 10.4 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 18.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 82.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 27.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 70.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 3.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 78.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 22.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 1.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 20.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 76.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 12.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 86.5 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 91.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 100.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 8.8 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 33.8 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 85.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 66.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 13.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 16.4 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 83.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 83.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 16.4 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 17.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 81.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 26.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 71.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 2.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 72.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 29.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 28.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 71.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 97.8 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 14.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 83.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 82.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 98.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 17.8 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 30.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 89.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 69.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 10.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 9.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 91.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 79.1 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 20.9 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 26.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 73.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 21.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 73.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 6.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 71.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 18.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 4.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 27.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 77.3 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 13.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 79.5 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 6.8 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 1.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 39.8 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 59.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 7.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 74.4 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 8.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 83.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 25.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 32.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 80.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 67.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 18.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Low | 19.4 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, High | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, Normal | 77.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | CRE, High | 3.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Normal | 70.1 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum | ALT, Low | 25.4 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 27.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 71.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 2.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 89.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 7.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 93.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 29.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 2.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 69.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 4.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 0.8 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 19.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 79.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 1.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 13.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 85.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 0.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 86.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 22.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 13.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 77.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 0.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 0 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 29.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 70.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 2.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 90.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 7.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 89.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 28.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 2.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 71.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 8.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 0 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 20.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 79.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 14.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 84.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 1.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 86.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 15.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 13.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 84.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 0.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 0.4 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 24.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 75.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 3.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 89.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 6.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 92.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 29.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 2.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 70.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 5.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 0.4 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 15.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 82.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 2.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 15.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 83.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 1.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 83.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 17.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 15.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 81.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 1.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 1.6 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 26.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 73.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 1.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 93.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 5.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 90.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 29.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 1.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 69.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 7.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 1.2 Percentage of participants |
Primary
Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 32.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 66.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 15.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 77.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 7.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Normal | 79.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Low | 26.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, Low | 15.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, Normal | 72.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | CRE, High | 5.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall | ALT, High | 1.6 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 days time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 44.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 88.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 55.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 77.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 11.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 43.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 56.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 3.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 91.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 4.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 18.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 5.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 2.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 98.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 7.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 14.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 78.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 48.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 51.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 96.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 3.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 6.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 91.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 51.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 48.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 81.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 18.3 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 12.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 5.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 1.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 93.3 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 98.9 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 14.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 80.9 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 85.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 1.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 87.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 19.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 97.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 17.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 80.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 6.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 91.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 81.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 27.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 72.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 20.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 18.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 81.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 7.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 93.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 39.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 59.1 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 10.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 6.1 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 87.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 92.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 90.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 7.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 94.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 83.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 10.4 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 46.3 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 89.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 11.9 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 100.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 85.1 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 14.9 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 53.7 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 6.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 days time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 52.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 84.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 48.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 76.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 15.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 55.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 44.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 2.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 90.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 14.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 9.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 7.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 2.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 98.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 14.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 11.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 74.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 57.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 43.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 97.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 7.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 92.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 37.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 62.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 86.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 11.8 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 15.7 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 10.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 3.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 89.9 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 96.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 1.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 98.9 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 12.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 75.3 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 1.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 86.5 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 82.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 24.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 98.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 13.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 87.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 6.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 92.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 86.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 28.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 71.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 10.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 8.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 87.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 3.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 6.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 97.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 34.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 65.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 97.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 11.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 3.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 88.1 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 94.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 89.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 9.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 92.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 80.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 49.3 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 94.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 19.4 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 97.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 95.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 49.3 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 7.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 1.5 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 47.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 82.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 53.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 1.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 74.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 17.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 50.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 50.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 2.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 93.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 13.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 13.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 5.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 98.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 1.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 11.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 23.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 64.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 40.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 59.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 96.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 3.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 8.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 86.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 5.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 53.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 46.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 2.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 80.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 17.5 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 10.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 2.3 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 3.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 97.7 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 3.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 96.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 13.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 68.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 86.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 86.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 31.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 97.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 11.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 85.6 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 97.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 88.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 32.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 67.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 14.4 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 6.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 93.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 12.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 89.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 46.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 52.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 3.1 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 10.8 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 95.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 87.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 92.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 7.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 94.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 86.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 3.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 53.7 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 97.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 11.9 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 98.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 97.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 3.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 46.3 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 28.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 74.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 72.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 80.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 26.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 62.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 38.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 2.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 95.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 13.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 7.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 3.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 2.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 98.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 14.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 5.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 81.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 20.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 80.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 95.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 5.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 97.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 3.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 36.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 64.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 71.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 29.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 14.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 97.8 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 1.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 1.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 98.9 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 19.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 85.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 80.9 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 84.3 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 14.6 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 97.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 20.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 78.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 98.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 78.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 14.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 85.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 22.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 4.4 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 95.6 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 8.8 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 92.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 51.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 47.1 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 92.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 2.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 7.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 5.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 7.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 88.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 4.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 89.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 91.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 5.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 88.1 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 86.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 53.7 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 95.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 9.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 100.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 94.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 6.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 46.3 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 10.4 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 47.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 79.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 53.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 82.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 21.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 57.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 43.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 2.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 92.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 12.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 6.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 6.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 99.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 11.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 9.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 80.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 22.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 78.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 99.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 2.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 94.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 4.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 44.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 56.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 77.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 23.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 7.9 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 14.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 4.5 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 85.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 95.5 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 6.7 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 76.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 93.3 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 89.9 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 23.6 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 98.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 4.4 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 13.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 84.6 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 97.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 82.4 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 33.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 67.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 15.4 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 4.4 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 95.6 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 14.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 79.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 61.8 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 38.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 95.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 7.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 4.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 2.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 19.1 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 92.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 2.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 82.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 89.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 2.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 2.9 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 86.2 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 4.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 87.7 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 3.1 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 67.7 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 96.9 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 7.7 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 100.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 93.8 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 6.2 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 29.2 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 4.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 9.2 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 3.1 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 37.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 71.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 1.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 61.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 74.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 28.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 49.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 50.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 3.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 91.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 13.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 12.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 5.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 2.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 97.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 1.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 9.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 8.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 82.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 29.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 69.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 1.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 95.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 4.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 1.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 94.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 4.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 40.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 59.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 71.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 28.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 9.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 6.7 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 92.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 98.9 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 16.9 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 77.5 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 83.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 1.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 88.8 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 22.5 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 98.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 3.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 14.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 80.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 98.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 82.4 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 36.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 63.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 19.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 6.6 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 93.4 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 10.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 88.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 57.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 42.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 97.1 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 5.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 4.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 2.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 11.8 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 86.8 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 8.8 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 89.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 89.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 4.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 88.1 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 7.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 82.1 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 59.7 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 95.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 10.4 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 97.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 95.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 37.3 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 7.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 3.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 3.0 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 35.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 82.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 65.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 1.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 73.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 18.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 62.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 37.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 1.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 94.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 18.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 9.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 5.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 2.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 98.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 18.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 6.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 75.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 30.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 69.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 96.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 3.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 3.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 95.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 1.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 31.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 67.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 1.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 82.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 17.3 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 9.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 11.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 4.5 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 87.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 93.3 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 97.8 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 6.7 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 61.8 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 93.3 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 1.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 88.8 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 38.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 100.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 12.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 85.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 3.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 95.6 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 85.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 35.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 64.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 14.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 5.5 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 92.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 7.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 95.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 45.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 52.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 91.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 4.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 7.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 2.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 89.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 5.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 91.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 92.6 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 5.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 88.1 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 3.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 83.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 3.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 41.8 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 94.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 11.9 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 95.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 92.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 7.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 52.2 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 10.4 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 3.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 6.0 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum
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
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 38.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 89.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 62.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 78.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 11.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 49.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 51.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 1.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 93.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 6.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 16.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 6.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 4.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 96.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 8.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 15.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 76.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 28.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 70.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 1.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 96.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 3.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 4.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 92.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 3.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 43.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 56.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 87.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 12.5 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 19.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 7.9 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 3.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 92.1 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 96.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 12.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 78.7 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 87.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 78.7 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 21.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 97.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 1.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 20.9 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 85.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 2.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 94.5 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 3.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 78.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 22.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 78.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 14.3 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 12.1 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 85.7 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 2.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 14.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 86.8 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 41.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 58.8 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 97.1 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 2.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 7.4 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 1.5 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 13.2 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 89.7 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 2.9 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 85.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 86.8 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 10.3 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Normal | 94.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, Normal | 83.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Low | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Low | 37.3 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, Normal | 94.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Platelets, High | 16.4 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Normal | 98.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Normal | 89.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, Low | 10.4 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, Normal | 62.7 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, Low | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | RBC, High | 4.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | WBC, High | 1.5 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum | Haemoglobin, High | 0 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 3 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 5.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 86.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 8.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 28.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 71.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 98.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 7.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 90.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 1.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 41.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 58.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 87.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 11.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 53.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 6.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 2.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 82.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 16.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 11.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 96.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 11.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 88.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 1.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 82.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 46.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 99.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 1.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 0.8 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 6 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 7.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 83.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 9.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 19.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 79.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 1.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 97.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 1.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 4.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 94.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 1.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 42.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 57.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 2.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 79.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 18.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 55.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 5.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 2.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 84.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 20.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 10.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 96.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 14.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 84.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 1.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 77.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 44.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 97.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 2.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 2.0 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 12 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 6.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 83.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 10.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 22.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 77.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 99.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 6.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 92.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 42.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 56.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 87.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 12.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 53.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 10.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 4.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 81.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 15.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 8.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 93.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 18.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 81.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 2.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 83.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 46.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 97.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 1.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 1.6 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 30 Days time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 4.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 81.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 13.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 24.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 75.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 98.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 1.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 5.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 93.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 35.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 65.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 86.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 13.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 62.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 4.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 6.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 83.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 13.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 12.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 92.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 25.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 73.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 0.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 1.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 85.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 37.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 98.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 1.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 1.2 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Day 30 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 4.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 83.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 11.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 18.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 80.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 1.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 96.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 1.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 5.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 93.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 1.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 39.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 59.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 1.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 87.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 10.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 62.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 3.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 3.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 82.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 14.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 14.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 95.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 15.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 2.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 83.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 1.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 84.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 35.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 97.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 1.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 2.0 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 + 6 Days time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 7.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 84.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 7.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 20.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 78.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 99.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 4.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 94.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 1.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 38.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 60.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 87.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 12.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 58.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 5.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 7.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 83.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 17.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 10.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 90.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 28.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 71.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 1.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 81.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 41.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 98.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 1.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 2.0 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Screening time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 3.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 84.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 11.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 12.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 86.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 1.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 97.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 1.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 3.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 94.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 1.6 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 33.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 66.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 1.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 80.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 18.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 67.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 2.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 1.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 81.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 21.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 15.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 97.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 10.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 89.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 1.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 77.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 32.9 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 97.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 1.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 2.7 Percentage of participants |
Primary
Percentage of Subjects With Haematological Laboratory Abnormalities, Overall
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.
Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with available results at the Month 6 time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 7.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 80.5 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 11.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 21.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 79.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 97.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 1.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 7.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 92.2 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 0.4 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 38.1 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 61.9 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 0.8 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 88.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 10.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Normal | 65.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Low | 6.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Low | 3.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, Normal | 81.5 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, High | 14.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | RBC, High | 11.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, Normal | 93.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Low | 17.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, High | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, Normal | 81.1 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | WBC, High | 2.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Neutrophils, High | 1.2 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Normal | 85.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Haemoglobin, Low | 34.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, Normal | 97.6 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Platelets, Low | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Subjects With Haematological Laboratory Abnormalities, Overall | Lymphocytes, High | 2.4 Percentage of participants |
Secondary
Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall
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.
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall | Anti-GP EBOV, Day 30 | 1739.756 Titers |
| GSK3390107A+Nimenrix Group | Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall | Anti-GP EBOV, Month 6 + Day 30 | 970.870 Titers |
| GSK3390107A+Nimenrix Group | Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall | Anti-GP EBOV, Month 6 | 1017.712 Titers |
| GSK3390107A+Nimenrix Group | Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall | Anti-GP EBOV, Month 12 | 909.092 Titers |
| GSK3390107A+Nimenrix Group | Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall | Anti-GP EBOV, Day 0 | 24.755 Titers |
| Nimenrix+GSK3390107A Group | Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall | Anti-GP EBOV, Month 12 | 889.641 Titers |
| Nimenrix+GSK3390107A Group | Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall | Anti-GP EBOV, Day 0 | 24.587 Titers |
| Nimenrix+GSK3390107A Group | Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall | Anti-GP EBOV, Day 30 | 24.372 Titers |
| Nimenrix+GSK3390107A Group | Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall | Anti-GP EBOV, Month 6 | 23.343 Titers |
| Nimenrix+GSK3390107A Group | Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall | Anti-GP EBOV, Month 6 + Day 30 | 1513.928 Titers |
Secondary
Anti-GP EBOV Antibody Titers, by Age Stratum
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
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days | 722.550 Titers |
| GSK3390107A+Nimenrix Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Day 30 | 1564.283 Titers |
| GSK3390107A+Nimenrix Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Day 0 | 29.526 Titers |
| GSK3390107A+Nimenrix Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 12 | 715.890 Titers |
| GSK3390107A+Nimenrix Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 6 | 705.913 Titers |
| Nimenrix+GSK3390107A Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Day 30 | 29.565 Titers |
| Nimenrix+GSK3390107A Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days | 1150.199 Titers |
| Nimenrix+GSK3390107A Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Day 0 | 31.545 Titers |
| Nimenrix+GSK3390107A Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 12 | 583.371 Titers |
| Nimenrix+GSK3390107A Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 6 | 23.328 Titers |
| GSK3390107A+Nimenrix 6-12YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 6 | 1030.880 Titers |
| GSK3390107A+Nimenrix 6-12YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Day 30 | 1394.540 Titers |
| GSK3390107A+Nimenrix 6-12YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days | 885.295 Titers |
| GSK3390107A+Nimenrix 6-12YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 12 | 751.765 Titers |
| GSK3390107A+Nimenrix 6-12YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Day 0 | 22.764 Titers |
| Nimenrix+GSK3390107A 6-12YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 6 | 21.834 Titers |
| Nimenrix+GSK3390107A 6-12YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Day 0 | 21.241 Titers |
| Nimenrix+GSK3390107A 6-12YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Day 30 | 21.879 Titers |
| Nimenrix+GSK3390107A 6-12YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days | 1399.458 Titers |
| Nimenrix+GSK3390107A 6-12YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 12 | 883.668 Titers |
| GSK3390107A+Nimenrix 1-5YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days | 1439.460 Titers |
| GSK3390107A+Nimenrix 1-5YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Day 0 | 22.473 Titers |
| GSK3390107A+Nimenrix 1-5YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 12 | 1424.270 Titers |
| GSK3390107A+Nimenrix 1-5YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Day 30 | 2405.635 Titers |
| GSK3390107A+Nimenrix 1-5YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 6 | 1482.304 Titers |
| Nimenrix+GSK3390107A 1-5YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Day 0 | 22.021 Titers |
| Nimenrix+GSK3390107A 1-5YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days | 2190.763 Titers |
| Nimenrix+GSK3390107A 1-5YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Day 30 | 22.300 Titers |
| Nimenrix+GSK3390107A 1-5YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 12 | 1412.293 Titers |
| Nimenrix+GSK3390107A 1-5YOA Group | Anti-GP EBOV Antibody Titers, by Age Stratum | Anti-GP EBOV, Month 6 | 25.141 Titers |
Secondary
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum
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
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days, S- | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 0, S+ | 23.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 30, S+ | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6, S- | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6, S+ | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 0, S- | 77.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 30, S- | 0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days, S+ | 100.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 0, S- | 67.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6, S- | 80.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 0, S+ | 33.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days, S+ | 100.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days, S- | 0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 30, S- | 70.4 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6, S+ | 20.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 30, S+ | 29.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6, S- | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 30, S- | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 0, S- | 85.4 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 0, S+ | 14.6 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6, S+ | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 30, S+ | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days, S- | 0 Percentage of participants |
| GSK3390107A+Nimenrix 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days, S+ | 100.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6, S- | 88.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 0, S- | 90.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 0, S+ | 9.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 30, S- | 90.8 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 30, S+ | 9.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days, S+ | 100.0 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6, S+ | 11.2 Percentage of participants |
| Nimenrix+GSK3390107A 6-12YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days, S- | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6, S- | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 30, S+ | 98.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 30, S- | 2.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6, S+ | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 0, S+ | 14.1 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days, S+ | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days, S- | 0 Percentage of participants |
| GSK3390107A+Nimenrix 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 0, S- | 85.9 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days, S- | 0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 0, S- | 89.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 30, S- | 90.4 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 30, S+ | 9.6 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6 + 30 Days, S+ | 100.0 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6, S- | 83.1 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Month 6, S+ | 16.9 Percentage of participants |
| Nimenrix+GSK3390107A 1-5YOA Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum | Anti-GP EBOV, Day 0, S+ | 10.4 Percentage of participants |
Secondary
Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall
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.
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for analysis of immunogenicity, which included all evaluable subjects who complied with the protocol requirements and procedures and for whom data concerning immunogenicity endpoint measures were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Day 0, S- | 82.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Day 0, S+ | 17.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Day 30, S- | 0.7 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Day 30, S+ | 99.3 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Month 6, S- | 0.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Month 6, S+ | 100.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Month 6 + 30 Days, S- | 0.0 Percentage of participants |
| GSK3390107A+Nimenrix Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Month 6 + 30 Days, S+ | 100.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Month 6 + 30 Days, S+ | 100.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Day 0, S- | 82.3 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Month 6, S- | 84.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Day 0, S+ | 17.7 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Month 6 + 30 Days, S- | 0.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Day 30, S- | 83.8 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Month 6, S+ | 16.0 Percentage of participants |
| Nimenrix+GSK3390107A Group | Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall | Anti-GP EBOV, Day 30, S+ | 16.2 Percentage of participants |