Phase 2
N=600
A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children
Virus Diseases
Bottom Line
View on ClinicalTrials.gov: NCT02548078 ↗Enrolled (actual)
600
Serious AEs
0.8%
Results posted
May 2018
Primary outcome: Primary: Number of Subjects With Solicited Local Symptoms, Overall — 127; 60; 4; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 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 (Biological)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Solicited Local Symptoms, Overall |
127; 60; 4; 0; 5; 1 | — |
| PRIMARY Number of Subjects With Solicited Local Symptoms, by Age Stratum |
31; 14; 41; 23; 55; 23 | — |
| PRIMARY Number of Subjects With Solicited General Symptoms, Overall |
33; 6; 0; 0; 32; 5 | — |
| PRIMARY Number of Subjects With Solicited General Symptoms, by Age Stratum |
20; 5; 13; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Unsolicited Adverse Events (AEs), Overall |
41; 24 | — |
| PRIMARY Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum |
12; 8; 6; 10; 23; 6 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
6.3; 10.2; 83.0; 81.1; 10.7; 8.7 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
13.0; 23.7; 3.4; 0; 0; 4.5 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
6.3; 10.2; 83.0; 81.1; 10.7; 8.7 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
13.0; 23.7; 3.4; 0; 0; 4.5 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
6.3; 10.2; 83.0; 81.1; 10.7; 8.7 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
13.0; 23.7; 3.4; 0; 0; 4.5 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
6.3; 10.2; 83.0; 81.1; 10.7; 8.7 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
13.0; 23.7; 3.4; 0; 0; 4.5 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
6.3; 10.2; 83.0; 81.1; 10.7; 8.7 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
13.0; 23.7; 3.4; 0; 0; 4.5 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
6.3; 10.2; 83.0; 81.1; 10.7; 8.7 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
13.0; 23.7; 3.4; 0; 0; 4.5 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
6.3; 10.2; 83.0; 81.1; 10.7; 8.7 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
13.0; 23.7; 3.4; 0; 0; 4.5 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, Overall |
6.3; 10.2; 83.0; 81.1; 10.7; 8.7 | — |
| PRIMARY Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum |
13.0; 23.7; 3.4; 0; 0; 4.5 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
32.4; 26.4; 66.8; 72.0; 0.8; 1.6 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
26.0; 27.8; 39.8; 25.6; 32.3; 25.4 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
32.4; 26.4; 66.8; 72.0; 0.8; 1.6 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
26.0; 27.8; 39.8; 25.6; 32.3; 25.4 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
32.4; 26.4; 66.8; 72.0; 0.8; 1.6 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
26.0; 27.8; 39.8; 25.6; 32.3; 25.4 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
32.4; 26.4; 66.8; 72.0; 0.8; 1.6 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
26.0; 27.8; 39.8; 25.6; 32.3; 25.4 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
32.4; 26.4; 66.8; 72.0; 0.8; 1.6 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
26.0; 27.8; 39.8; 25.6; 32.3; 25.4 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
32.4; 26.4; 66.8; 72.0; 0.8; 1.6 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
26.0; 27.8; 39.8; 25.6; 32.3; 25.4 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
32.4; 26.4; 66.8; 72.0; 0.8; 1.6 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
26.0; 27.8; 39.8; 25.6; 32.3; 25.4 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall |
32.4; 26.4; 66.8; 72.0; 0.8; 1.6 | — |
| PRIMARY Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum |
26.0; 27.8; 39.8; 25.6; 32.3; 25.4 | — |
| PRIMARY Number of Subjects With Adverse Events of Specific Interest (AESI), Overall |
0; 0 | — |
| PRIMARY Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Subjects With Serious Adverse Events, Overall |
2; 2 | — |
| PRIMARY Number of Subjects With Serious Adverse Events, by Age Stratum |
0; 1; 1; 1; 1; 0 | — |
| SECONDARY Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall |
24.755; 24.587; 1739.756; 24.372; 1017.712; 23.343 | — |
| SECONDARY Anti-GP EBOV Antibody Titers, by Age Stratum |
29.526; 31.545; 22.764; 21.241; 22.473; 22.021 | — |
| SECONDARY Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall |
82.7; 82.3; 17.3; 17.7; 0.7; 83.8 | — |
| SECONDARY Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum |
77.0; 67.0; 85.4; 90.8; 85.9; 89.6 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02548078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.