Virus DiseasesPhase 2NCT02548078

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

A Phase 2 study testing GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) and Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine in people with Virus Diseases, run by GlaxoSmithKline at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 1 year to 17 yearsHealthy volunteers can take part
Conditions the study is for: Virus Diseases
What is being tested?: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) and Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 2 sitesin 2 countries
Study dates: 9 Nov 2015to 15 May 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 17 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

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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

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Mali1 site

GSK Investigational Site
Bamako

Other trials in Mali

Senegal1 site

GSK Investigational Site
Dakar

Other trials in Senegal

About this study

Official title: Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Children in Africa

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.

Conditions: Virus Diseases
Being tested: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A), Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine
Keywords: Protection against Ebola Zaire virus
Medical subject headings: Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)Biological
A single dose administered intramuscular
Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccineBiological
A single dose administered intramuscular

Study groups in NCT02548078
Study group	Role	What they receive
GSK3390107A+Nimenrix Group	Experimental	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. Receives: 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
Nimenrix+GSK3390107A Group	Experimental	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. Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During the entire study period: From Screening to Month 12

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Day 0, Day 30, Month 6 and Month 6 + 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Nov 201515 May 2017

First posted14 Sep 2015 (estimated)
Study start9 Nov 2015
Primary completion15 May 2017
Study completion15 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Virus DiseasesStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02548078
Sponsor's protocol ID: 202090
Other IDs: 2014-004714-28, 2014
Status last verified: Mar 2018
First submitted: 10 Sep 2015
Last updated: 3 May 2018
Results posted: Yes, on ClinicalTrials.gov

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.
PubMed 32199492

Want to know more?

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Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity Study of GSK Biologicals' Investigational Recombinant Chimpanzee Adenovirus Type 3-vectored Ebola Zaire Vaccine (GSK3390107A) in Children in Africa
ClinicalTrials.gov ID: NCT02548078
Acronym / sponsor ID: 202090
Conditions: Virus Diseases
Keywords: Protection against Ebola Zaire virus
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 9 Nov 2015 (actual)
Primary completion: 15 May 2017 (actual)
Study completion: 15 May 2017 (actual)
First posted: 14 Sep 2015 (estimated)
Results: Posted 3 May 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
GSK3390107A+Nimenrix Group	Experimental	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 vaccineSubjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.
Nimenrix+GSK3390107A Group	Experimental	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 vaccineSubjects 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.

Who may qualify

Ages: 1 year to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (12 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)A single dose administered intramuscular	Biological	GSK3390107A+Nimenrix Group, Nimenrix+GSK3390107A Group
Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccineA single dose administered intramuscular	Biological	GSK3390107A+Nimenrix Group, Nimenrix+GSK3390107A Group

Primary outcome

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.

4 secondary outcomes

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 Antibody Titers, by Age Stratum
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
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
Time frame: At Day 0, Day 30, Month 6 and Month 6 + 30 Days

Results and safety

Results posted to the registry on 3 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK3390107A+Nimenrix Group	300	295
Nimenrix+GSK3390107A Group	300	294

Primary outcome: 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). Count of participants. Unit: Participants

Measure	GSK3390107A+Nimenrix Group n = 300	Nimenrix+GSK3390107A Group n = 300
Any Pain	127	60
Grade 3 Pain	4	0
Any Swelling	5	1
Grade 3 Swelling	1	0

Population analysed: 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.

Primary outcome: 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). Count of participants. Unit: Participants

Measure	GSK3390107A+Nimenrix 13-17YOA Group n = 100	Nimenrix+GSK3390107A 13-17YOA Group n = 100	GSK3390107A+Nimenrix 6-12YOA Group n = 99	Nimenrix+GSK3390107A 6-12YOA Group n = 101	GSK3390107A+Nimenrix 1-5YOA Group n = 101	Nimenrix+GSK3390107A 1-5YOA Group n = 99
Any Pain	31	14	41	23	55	23
Grade 3 Pain	0	0	1	0	3	0
Any Swelling	1	0	3	1	1	0
Grade 3 Swelling	0	0	1	0	0	0

Primary outcome: 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). Count of participants. Unit: Participants

Measure	GSK3390107A+Nimenrix Group n = 300	Nimenrix+GSK3390107A Group n = 300
Any Fatigue	33	6
Grade 3 Fatigue	0	0
Related Fatigue	32	5
Any Fever	95	28
Grade 3 Fever	1	0
Related Fever	89	26
Any Gastrointestinal symptoms	16	6
Grade 3 Gastrointestinal symptoms	0	0

Primary outcome: 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). Count of participants. Unit: Participants

Measure	GSK3390107A+Nimenrix 13-17YOA Group n = 100	Nimenrix+GSK3390107A 13-17YOA Group n = 100	GSK3390107A+Nimenrix 6-12YOA Group n = 99	Nimenrix+GSK3390107A 6-12YOA Group n = 101	GSK3390107A+Nimenrix 1-5YOA Group n = 101	Nimenrix+GSK3390107A 1-5YOA Group n = 99
Any Fatigue	20	5	13	1	–	–
Grade 3 Fatigue	0	0	0	0	–	–
Related Fatigue	20	4	12	1	–	–
Any Fever	20	4	25	1	50	23
Grade 3 Fever	0	0	0	0	1	0
Related Fever	17	4	23	1	49	21
Any Gastrointestinal symptoms	9	2	7	4	–	–
Grade 3 Gastrointestinal symptoms	0	0	0	0	–	–

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period; SAEs: from Screening up to study end at Month 12.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK3390107A+Nimenrix Group	2 of 300 (0.7%)	194 of 300 (64.7%)	1 of 300
Nimenrix+GSK3390107A Group	3 of 300 (1%)	89 of 300 (29.7%)	0 of 300

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32199492Tapia 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Mali, Senegal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 42 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02548078, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.