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

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

Tracking Information
First Submitted Date  ICMJE September 10, 2015
First Posted Date  ICMJE September 14, 2015
Results First Submitted Date  ICMJE March 30, 2018
Results First Posted Date  ICMJE May 3, 2018
Last Update Posted Date May 3, 2018
Actual Study Start Date  ICMJE November 9, 2015
Actual Primary Completion Date May 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Number of Subjects With Solicited Local Symptoms, Overall [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At Screening ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [ Time Frame: At Day 3. ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [ Time Frame: At Day 3 ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [ Time Frame: At Day 6. ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [ Time Frame: At Day 6 ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [ Time Frame: At Day 30. ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [ Time Frame: At Day 30 ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [ Time Frame: At Month 6. ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [ Time Frame: At Month 6 ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [ Time Frame: At Month 6 + 6 Days. ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [ Time Frame: At Month 6 + 6 Days ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [ Time Frame: At Month 6 + 30 Days. ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [ Time Frame: At Month 6 + 30 Days ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, Overall [ Time Frame: At Month 12. ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum [ Time Frame: At Month 12 ]
    Haematological parameters assessed included: complete blood count (red blood cells [RBC], neutrophils, lymphocytes, white blood cells [WBC], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [ Time Frame: At Screening. ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [ Time Frame: At Screening ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [ Time Frame: At Day 3. ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [ Time Frame: At Day 3 ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [ Time Frame: At Day 6. ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [ Time Frame: At Day 6 ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [ Time Frame: At Day 30. ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [ Time Frame: At Day 30 ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [ Time Frame: At Month 6. ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [ Time Frame: At Month 6 ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [ Time Frame: At Month 6 + 6 Days. ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [ Time Frame: At Month 6 + 6 Days ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [ Time Frame: At Month 6 + 30 Days. ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [ Time Frame: At Month 6 + 30 Days ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall [ Time Frame: At Month 12. ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for all subjects, in both groups. Reference range indicators used were: high, low, normal.
  • Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum [ Time Frame: At Month 12 ]
    Biochemical parameters assessed included: alanine aminotransferase [ALT], creatinine [CRE] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.
  • Number of Subjects With Adverse Events of Specific Interest (AESI), Overall [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: During the entire study period: From Screening to Month 12 ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. SAEs, for this endpoint, were assessed in all subjects, in both groups.
  • Number of Subjects With Serious Adverse Events, by Age Stratum [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
  • Occurrence of each solicited local and general AE [ Time Frame: At Day 7 after each vaccination (i.e. the day of vaccination and 6 subsequent days) in all subjects, in both groups. ]
  • Occurrence of any unsolicited AE [ Time Frame: At 30 days after each vaccination (i.e. the day of vaccination and 29 subsequent days), in all subjects, in both groups. ]
  • Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [ Time Frame: At Screening. ]
  • Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [ Time Frame: At Day 3. ]
  • Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [ Time Frame: At Day 6. ]
  • Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [ Time Frame: At Day 30. ]
  • Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [ Time Frame: At Month 6. ]
  • Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [ Time Frame: At Month 6 + 6 days ]
  • Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ALT], creatinine) laboratory abnormalities [ Time Frame: At Month 6 + 30 days ]
  • Occurrence of haematological (complete blood count [CBC], including differential count and platelet count) and biochemical (alanine aminotransferase [ ALT], creatinine) laboratory abnormalities [ Time Frame: At Month 12 ]
  • Occurrence of clinical symptoms of thrombocytopenia (AE of specific interest) [ Time Frame: At Day 7 after vaccination (i.e. Day 0 up to Day 6), in all subjects, in both groups ]
  • Occurrence of any SAE, in all subjects, in both groups. [ Time Frame: For the whole study duration (from Day 0 to Month 12) ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2018)
  • Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall [ Time Frame: At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12. ]
    Anti-GP EBOV antibodies were expressed as Geometric Mean Titers (GMTs), as measured by the Enzyme-Linked Immunosorbent Assay (ELISA) and assessed in all subjects, in both groups.
  • Anti-GP EBOV Antibody Titers, by Age Stratum [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2015)
  • Anti-GP EBOV antibody titres, as measured by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: At Day 0 and Day 30 in all subjects in both groups. ]
  • Anti-GP EBOV antibody titres, as measured by enzyme-linked immunosorbent assay (ELISA) [ Time Frame: At Month 6 and Month 6 + 30 days in all subjects, in the Group MENACWY TT/ EBO-Z ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children
Official Title  ICMJE Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Children in Africa
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Virus Diseases
Intervention  ICMJE
  • Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
    A single dose administered intramuscular
  • Biological: Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine
    A single dose administered intramuscular
Study Arms  ICMJE
  • Experimental: GSK3390107A+Nimenrix Group
    Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
    Interventions:
    • Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
    • Biological: Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine
  • Experimental: Nimenrix+GSK3390107A Group
    Subjects in the Nimenrix +GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
    Interventions:
    • Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)
    • Biological: Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine
Publications * Tapia MD, Sow SO, Mbaye KD, Thiongane A, Ndiaye BP, Ndour CT, Mboup S, Keshinro B, Kinge TN, Vernet G, Bigna JJ, Oguche S, Koram KA, Asante KP, Gobert P, Hogrefe WR, De Ryck I, Debois M, Bourguignon P, Jongert E, Ballou WR, Koutsoukos M, Roman F; Zaire EBola Research Alliance group. Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2020 Jun;20(6):719-730. doi: 10.1016/S1473-3099(20)30019-0. Epub 2020 Mar 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 10, 2015)
600
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 15, 2017
Actual Primary Completion Date May 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Mali,   Senegal
Removed Location Countries Nigeria
 
Administrative Information
NCT Number  ICMJE NCT02548078
Other Study ID Numbers  ICMJE 202090
2014-004714-28 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP