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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
600
A single dose administered intramuscular
A single dose administered intramuscular
GSK Investigational Site
Bamako, Mali
GSK Investigational Site
Dakar, Senegal
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)
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)
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)
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)
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)
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)
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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)
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)
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
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
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.
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
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.
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
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