Trial · NCT02485301
A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults
NCT02485301, Phase 2, Completed, GlaxoSmithKline; results first posted 2018-01-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults. Trials, record NCT02485301. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02485301
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Adults
- NCT number
- NCT02485301
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 3,024 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Virus Diseases
- Interventions
- GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A), Placebo
- First posted
- 2015-06-30
- Last updated
- 2018-01-04
- Results first posted
- 2018-01-04
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Solicited Local Adverse Events | During the 7-Day (Days 0-6) post-vaccination period | Assessed solicited local adverse events were pain, redness and swelling. Any = occurrence of any solicited local adverse event regardless of their intensity grade. Grade 3 Pain = significant pain at rest. Prevented normal every day activities. Grade 3 Redness/Swelling = redness/swelling spreading beyond 100 millimeters (mm) from injection site. |
| Primary | Number of Subjects With Solicited General Adverse Events | During the 7-Day (Days 0-6) post-vaccination period | Assessed solicited general adverse events were fatigue, fever \[defined as axillary temperature higher than or equal to (≥) 37.5 degrees Celsius (°C)\], gastrointestinal (gastro) adverse events \[nausea, vomiting, diarrhoea and/or abdominal pain\] and headache. Any = occurrence of any general adverse events regardless of intensity grade or relationship to vaccination. Grade 3 fatigue, gastrointestinal symptoms and headache = adverse event that prevented normal activities. Grade 3 fever = fever ≥ 39.5 °C. Related = adverse event assessed by the investigator as related to the vaccination. |
| Primary | Number of Subjects With Unsolicited Adverse Events (AEs) | During the 30-Day (Days 0-29) post-vaccination period | 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 out-side 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. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | 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. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | 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. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | 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. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | 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. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | 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. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | 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. Reference range indicators used were: high, low, normal. |
| Primary | Percentage of Subjects With Haematological Laboratory Abnormalities | 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. Reference range indicators used were: high, low, normal. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes23
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects With Solicited Local Adverse Events | During the 7-Day (Days 0-6) post-vaccination period | The analysis was performed on the Total Vaccinated Cohort - Adverse Event (AE) and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Solicited General Adverse Events | During the 7-Day (Days 0-6) post-vaccination period | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented, who filled in their symptom sheets. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Subjects With Unsolicited Adverse Events (AEs) | During the 30-Day (Days 0-29) post-vaccination period | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Percentage of Subjects With Haematological Laboratory Abnormalities | At Screening | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Screening. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects With Haematological Laboratory Abnormalities | At Day 3 | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 3. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects With Haematological Laboratory Abnormalities | At Day 6 | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 6. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects With Haematological Laboratory Abnormalities | At Day 30 | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Day 30. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects With Haematological Laboratory Abnormalities | At Month 6 | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects With Haematological Laboratory Abnormalities | At Month 6 + 6 Days | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 6 Days timepoint. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Subjects With Haematological Laboratory Abnormalities | At Month 6 + 30 Days | The analysis was performed on the Total Vaccinated Cohort - AE and Humoral Immunity Sub-cohort, which included all subjects with at least one vaccine administration documented and with available results at Month 6 + 30 Days timepoint. | Percentage of participants | NUMBER |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 outcomesResults by group399
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects With Solicited Local Adverse Events | GSK3390107A Group | Any Pain | 356 | Participants | |
| Number of Subjects With Solicited Local Adverse Events | Placebo+GSK3390107A Group | Any Pain | 57 | Participants | |
| Number of Subjects With Solicited Local Adverse Events | GSK3390107A Group | Grade 3 Pain | 3 | Participants | |
| Number of Subjects With Solicited Local Adverse Events | Placebo+GSK3390107A Group | Grade 3 Pain | 0 | Participants | |
| Number of Subjects With Solicited Local Adverse Events | GSK3390107A Group | Any Redness | 2 | Participants | |
| Number of Subjects With Solicited Local Adverse Events | Placebo+GSK3390107A Group | Any Redness | 0 | Participants | |
| Number of Subjects With Solicited Local Adverse Events | GSK3390107A Group | Grade 3 Redness | 0 | Participants | |
| Number of Subjects With Solicited Local Adverse Events | Placebo+GSK3390107A Group | Grade 3 Redness | 0 | Participants | |
| Number of Subjects With Solicited Local Adverse Events | GSK3390107A Group | Any Swelling | 9 | Participants | |
| Number of Subjects With Solicited Local Adverse Events | Placebo+GSK3390107A Group | Any Swelling | 5 | Participants |
1 to 10 of 399Source ClinicalTrials.gov
See all 399 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GSK3390107A Group | 1,509 | |
| Overall Study | STARTED | Placebo+GSK3390107A Group | 1,504 | |
| Overall Study | COMPLETED | GSK3390107A Group | 1,471 | |
| Overall Study | COMPLETED | Placebo+GSK3390107A Group | 1,455 | |
| Overall Study | NOT COMPLETED | GSK3390107A Group | 38 | |
| Overall Study | NOT COMPLETED | Placebo+GSK3390107A Group | 49 |
Source ClinicalTrials.gov
Adverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pain | General disorders | GSK3390107A Group | 356 | 749 | 680 |
| other | Pain | General disorders | Placebo+GSK3390107A Group | 60 | 751 | 86 |
| other | Fatigue | General disorders | GSK3390107A Group | 284 | 749 | 448 |
| other | Fatigue | General disorders | Placebo+GSK3390107A Group | 94 | 751 | 179 |
| other | Pyrexia | General disorders | GSK3390107A Group | 106 | 749 | 124 |
| other | Pyrexia | General disorders | Placebo+GSK3390107A Group | 25 | 751 | 30 |
| other | Headache | Nervous system disorders | GSK3390107A Group | 345 | 749 | 570 |
| other | Headache | Nervous system disorders | Placebo+GSK3390107A Group | 136 | 751 | 249 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | GSK3390107A Group | 73 | 749 | 125 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | Placebo+GSK3390107A Group | 49 | 751 | 93 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GSK3390107A Group | 1 | 1,509 |
| Total, all-cause mortality | Placebo+GSK3390107A Group | 2 | 1,504 |
| Total, other adverse events | GSK3390107A Group | 530 | 749 |
| Total, other adverse events | Placebo+GSK3390107A Group | 230 | 751 |
| Total, serious adverse events | GSK3390107A Group | 11 | 1,509 |
| Total, serious adverse events | Placebo+GSK3390107A Group | 18 | 1,504 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32199491 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GSK3390107A Group vs Placebo+GSK3390107A Group: Number of Subjects With Adverse Events of Specific Interest (AESI) | Trial comparisons |
| GSK3390107A Group vs Placebo+GSK3390107A Group: Number of Subjects With Serious Adverse Events (SAEs) | Trial comparisons |
| GSK3390107A Group vs Placebo+GSK3390107A Group: Number of Subjects With Unsolicited Adverse Events (AEs) | Trial comparisons |
| GSK3390107A Group vs Placebo+GSK3390107A Group: deaths from any cause | Trial comparisons |
| GSK3390107A Group vs Placebo+GSK3390107A Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02485301
GET https://conductscience.org/api/trials/v1/NCT02485301/registered?page=2