Who is sponsoring NCT02548078?

NCT02548078 is sponsored by GlaxoSmithKline.

What condition does NCT02548078 study?

NCT02548078 studies Virus Diseases.

Is NCT02548078 still recruiting?

NCT02548078 is currently completed. Last updated 3 May 2018.

Are results published for NCT02548078?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-05-03 · How we verify

NCT02548078

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 3 May 2018

What this trial tests

Phase 2 trial testing GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) in Virus Diseases in 600 participants. Completed in 15 May 2017.

Timeline

9 November 2015

Primary endpoint
15 May 2017

15 May 2017

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	prevention
Enrollment	600
Start date	9 November 2015
Primary completion	15 May 2017
Estimated completion	15 May 2017
Sites	2 locations across Senegal, Mali

Drugs / interventions 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

Conditions studied

Virus Diseases — all drugs for Virus Diseases →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 1 to 17, any sex, with Virus Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With Solicited Local Symptoms, Overall Primary · 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.

Any Pain

Group	Value	95% CI
GSK3390107A+Nimenrix Group	127
Nimenrix+GSK3390107A Group	60

Grade 3 Pain

Group	Value	95% CI
GSK3390107A+Nimenrix Group	4
Nimenrix+GSK3390107A Group	0

Any Swelling

Group	Value	95% CI
GSK3390107A+Nimenrix Group	5
Nimenrix+GSK3390107A Group	1

Grade 3 Swelling

Group	Value	95% CI
GSK3390107A+Nimenrix Group	1
Nimenrix+GSK3390107A Group	0

Number of Subjects With Solicited Local Symptoms, by Age Stratum Primary · 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.

Any Pain

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	31
Nimenrix+GSK3390107A 13-17YOA Group	14
GSK3390107A+Nimenrix 6-12YOA Group	41
Nimenrix+GSK3390107A 6-12YOA Group	23
GSK3390107A+Nimenrix 1-5YOA Group	55
Nimenrix+GSK3390107A 1-5YOA Group	23

Grade 3 Pain

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	0
Nimenrix+GSK3390107A 13-17YOA Group	0
GSK3390107A+Nimenrix 6-12YOA Group	1
Nimenrix+GSK3390107A 6-12YOA Group	0
GSK3390107A+Nimenrix 1-5YOA Group	3
Nimenrix+GSK3390107A 1-5YOA Group	0

Any Swelling

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	1
Nimenrix+GSK3390107A 13-17YOA Group	0
GSK3390107A+Nimenrix 6-12YOA Group	3
Nimenrix+GSK3390107A 6-12YOA Group	1
GSK3390107A+Nimenrix 1-5YOA Group	1
Nimenrix+GSK3390107A 1-5YOA Group	0

Grade 3 Swelling

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	0
Nimenrix+GSK3390107A 13-17YOA Group	0
GSK3390107A+Nimenrix 6-12YOA Group	1
Nimenrix+GSK3390107A 6-12YOA Group	0
GSK3390107A+Nimenrix 1-5YOA Group	0
Nimenrix+GSK3390107A 1-5YOA Group	0

Number of Subjects With Solicited General Symptoms, Overall Primary · 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

Any Fatigue

Group	Value	95% CI
GSK3390107A+Nimenrix Group	33
Nimenrix+GSK3390107A Group	6

Grade 3 Fatigue

Group	Value	95% CI
GSK3390107A+Nimenrix Group	0
Nimenrix+GSK3390107A Group	0

Related Fatigue

Group	Value	95% CI
GSK3390107A+Nimenrix Group	32
Nimenrix+GSK3390107A Group	5

Any Fever

Group	Value	95% CI
GSK3390107A+Nimenrix Group	95
Nimenrix+GSK3390107A Group	28

Grade 3 Fever

Group	Value	95% CI
GSK3390107A+Nimenrix Group	1
Nimenrix+GSK3390107A Group	0

Related Fever

Group	Value	95% CI
GSK3390107A+Nimenrix Group	89
Nimenrix+GSK3390107A Group	26

Any Gastrointestinal symptoms

Group	Value	95% CI
GSK3390107A+Nimenrix Group	16
Nimenrix+GSK3390107A Group	6

Grade 3 Gastrointestinal symptoms

Group	Value	95% CI
GSK3390107A+Nimenrix Group	0
Nimenrix+GSK3390107A Group	0

Number of Subjects With Solicited General Symptoms, by Age Stratum Primary · During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)

Any Fatigue

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	20
Nimenrix+GSK3390107A 13-17YOA Group	5
GSK3390107A+Nimenrix 6-12YOA Group	13
Nimenrix+GSK3390107A 6-12YOA Group	1

Grade 3 Fatigue

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	0
Nimenrix+GSK3390107A 13-17YOA Group	0
GSK3390107A+Nimenrix 6-12YOA Group	0
Nimenrix+GSK3390107A 6-12YOA Group	0

Related Fatigue

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	20
Nimenrix+GSK3390107A 13-17YOA Group	4
GSK3390107A+Nimenrix 6-12YOA Group	12
Nimenrix+GSK3390107A 6-12YOA Group	1

Any Fever

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	20
Nimenrix+GSK3390107A 13-17YOA Group	4
GSK3390107A+Nimenrix 6-12YOA Group	25
Nimenrix+GSK3390107A 6-12YOA Group	1
GSK3390107A+Nimenrix 1-5YOA Group	50
Nimenrix+GSK3390107A 1-5YOA Group	23

Grade 3 Fever

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	0
Nimenrix+GSK3390107A 13-17YOA Group	0
GSK3390107A+Nimenrix 6-12YOA Group	0
Nimenrix+GSK3390107A 6-12YOA Group	0
GSK3390107A+Nimenrix 1-5YOA Group	1
Nimenrix+GSK3390107A 1-5YOA Group	0

Related Fever

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	17
Nimenrix+GSK3390107A 13-17YOA Group	4
GSK3390107A+Nimenrix 6-12YOA Group	23
Nimenrix+GSK3390107A 6-12YOA Group	1
GSK3390107A+Nimenrix 1-5YOA Group	49
Nimenrix+GSK3390107A 1-5YOA Group	21

Any Gastrointestinal symptoms

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	9
Nimenrix+GSK3390107A 13-17YOA Group	2
GSK3390107A+Nimenrix 6-12YOA Group	7
Nimenrix+GSK3390107A 6-12YOA Group	4

Grade 3 Gastrointestinal symptoms

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	0
Nimenrix+GSK3390107A 13-17YOA Group	0
GSK3390107A+Nimenrix 6-12YOA Group	0
Nimenrix+GSK3390107A 6-12YOA Group	0

Number of Subjects With Unsolicited Adverse Events (AEs), Overall Primary · 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.

Group	Value	95% CI
GSK3390107A+Nimenrix Group	41
Nimenrix+GSK3390107A Group	24

Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum Primary · 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

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	12
Nimenrix+GSK3390107A 13-17YOA Group	8
GSK3390107A+Nimenrix 6-12YOA Group	6
Nimenrix+GSK3390107A 6-12YOA Group	10
GSK3390107A+Nimenrix 1-5YOA Group	23
Nimenrix+GSK3390107A 1-5YOA Group	6

Percentage of Subjects With Haematological Laboratory Abnormalities, Overall Primary · 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.

RBC, Low

Group	Value	95% CI
GSK3390107A+Nimenrix Group	3.9
Nimenrix+GSK3390107A Group	2.7

RBC, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix Group	84.4
Nimenrix+GSK3390107A Group	81.8

RBC, High

Group	Value	95% CI
GSK3390107A+Nimenrix Group	11.7
Nimenrix+GSK3390107A Group	15.5

Neutrophils, Low

Group	Value	95% CI
GSK3390107A+Nimenrix Group	12.8
Nimenrix+GSK3390107A Group	10.9

Neutrophils, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix Group	86.4
Nimenrix+GSK3390107A Group	89.1

Neutrophils, High

Group	Value	95% CI
GSK3390107A+Nimenrix Group	0.8
Nimenrix+GSK3390107A Group	0

Lymphocytes, Low

Group	Value	95% CI
GSK3390107A+Nimenrix Group	1.6
Nimenrix+GSK3390107A Group	0

Lymphocytes, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix Group	97.3
Nimenrix+GSK3390107A Group	97.3

Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum Primary · 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.

RBC, Low

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	7.0
Nimenrix+GSK3390107A 13-17YOA Group	5.0
GSK3390107A+Nimenrix 6-12YOA Group	1.1
Nimenrix+GSK3390107A 6-12YOA Group	1.1
GSK3390107A+Nimenrix 1-5YOA Group	2.9
Nimenrix+GSK3390107A 1-5YOA Group	1.5

RBC, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	80.0
Nimenrix+GSK3390107A 13-17YOA Group	81.0
GSK3390107A+Nimenrix 6-12YOA Group	84.3
Nimenrix+GSK3390107A 6-12YOA Group	78.0
GSK3390107A+Nimenrix 1-5YOA Group	91.2
Nimenrix+GSK3390107A 1-5YOA Group	88.1

RBC, High

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	13.0
Nimenrix+GSK3390107A 13-17YOA Group	14.0
GSK3390107A+Nimenrix 6-12YOA Group	14.6
Nimenrix+GSK3390107A 6-12YOA Group	20.9
GSK3390107A+Nimenrix 1-5YOA Group	5.9
Nimenrix+GSK3390107A 1-5YOA Group	10.4

Neutrophils, Low

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	28.0
Nimenrix+GSK3390107A 13-17YOA Group	20.0
GSK3390107A+Nimenrix 6-12YOA Group	0
Nimenrix+GSK3390107A 6-12YOA Group	4.4
GSK3390107A+Nimenrix 1-5YOA Group	7.4
Nimenrix+GSK3390107A 1-5YOA Group	6.0

Neutrophils, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	72.0
Nimenrix+GSK3390107A 13-17YOA Group	80.0
GSK3390107A+Nimenrix 6-12YOA Group	97.8
Nimenrix+GSK3390107A 6-12YOA Group	95.6
GSK3390107A+Nimenrix 1-5YOA Group	92.6
Nimenrix+GSK3390107A 1-5YOA Group	94.0

Neutrophils, High

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	0
Nimenrix+GSK3390107A 13-17YOA Group	0
GSK3390107A+Nimenrix 6-12YOA Group	2.2
Nimenrix+GSK3390107A 6-12YOA Group	0
GSK3390107A+Nimenrix 1-5YOA Group	0
Nimenrix+GSK3390107A 1-5YOA Group	0

Lymphocytes, Low

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	0
Nimenrix+GSK3390107A 13-17YOA Group	0
GSK3390107A+Nimenrix 6-12YOA Group	0
Nimenrix+GSK3390107A 6-12YOA Group	0
GSK3390107A+Nimenrix 1-5YOA Group	5.9
Nimenrix+GSK3390107A 1-5YOA Group	0

Lymphocytes, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	98.0
Nimenrix+GSK3390107A 13-17YOA Group	95.0
GSK3390107A+Nimenrix 6-12YOA Group	100.0
Nimenrix+GSK3390107A 6-12YOA Group	97.8
GSK3390107A+Nimenrix 1-5YOA Group	92.6
Nimenrix+GSK3390107A 1-5YOA Group	100.0

Percentage of Subjects With Haematological Laboratory Abnormalities, Overall Primary · At Day 3.

RBC, Low

Group	Value	95% CI
GSK3390107A+Nimenrix Group	5.1
Nimenrix+GSK3390107A Group	6.3

RBC, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix Group	86.8
Nimenrix+GSK3390107A Group	82.4

RBC, High

Group	Value	95% CI
GSK3390107A+Nimenrix Group	8.2
Nimenrix+GSK3390107A Group	11.3

Neutrophils, Low

Group	Value	95% CI
GSK3390107A+Nimenrix Group	28.4
Nimenrix+GSK3390107A Group	11.7

Neutrophils, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix Group	71.2
Nimenrix+GSK3390107A Group	88.3

Neutrophils, High

Group	Value	95% CI
GSK3390107A+Nimenrix Group	0.4
Nimenrix+GSK3390107A Group	0

Lymphocytes, Low

Group	Value	95% CI
GSK3390107A+Nimenrix Group	0.8
Nimenrix+GSK3390107A Group	0

Lymphocytes, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix Group	98.4
Nimenrix+GSK3390107A Group	99.2

Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum Primary · 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.

RBC, Low

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	6.0
Nimenrix+GSK3390107A 13-17YOA Group	9.0
GSK3390107A+Nimenrix 6-12YOA Group	2.2
Nimenrix+GSK3390107A 6-12YOA Group	4.4
GSK3390107A+Nimenrix 1-5YOAGroup	7.4
Nimenrix+GSK3390107A 1-5YOA Group	4.6

RBC, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	82.0
Nimenrix+GSK3390107A 13-17YOA Group	80.0
GSK3390107A+Nimenrix 6-12YOA Group	89.9
Nimenrix+GSK3390107A 6-12YOA Group	82.4
GSK3390107A+Nimenrix 1-5YOAGroup	89.7
Nimenrix+GSK3390107A 1-5YOA Group	86.2

RBC, High

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	12.0
Nimenrix+GSK3390107A 13-17YOA Group	11.0
GSK3390107A+Nimenrix 6-12YOA Group	7.9
Nimenrix+GSK3390107A 6-12YOA Group	13.2
GSK3390107A+Nimenrix 1-5YOAGroup	2.9
Nimenrix+GSK3390107A 1-5YOA Group	9.2

Neutrophils, Low

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	47.0
Nimenrix+GSK3390107A 13-17YOA Group	22.0
GSK3390107A+Nimenrix 6-12YOA Group	14.6
Nimenrix+GSK3390107A 6-12YOA Group	4.4
GSK3390107A+Nimenrix 1-5YOAGroup	19.1
Nimenrix+GSK3390107A 1-5YOA Group	6.2

Neutrophils, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	53.0
Nimenrix+GSK3390107A 13-17YOA Group	78.0
GSK3390107A+Nimenrix 6-12YOA Group	85.4
Nimenrix+GSK3390107A 6-12YOA Group	95.6
GSK3390107A+Nimenrix 1-5YOAGroup	79.4
Nimenrix+GSK3390107A 1-5YOA Group	93.8

Neutrophils, High

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	0
Nimenrix+GSK3390107A 13-17YOA Group	0
GSK3390107A+Nimenrix 6-12YOA Group	0
Nimenrix+GSK3390107A 6-12YOA Group	0
GSK3390107A+Nimenrix 1-5YOAGroup	1.5
Nimenrix+GSK3390107A 1-5YOA Group	0

Lymphocytes, Low

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	0
Nimenrix+GSK3390107A 13-17YOA Group	0
GSK3390107A+Nimenrix 6-12YOA Group	0
Nimenrix+GSK3390107A 6-12YOA Group	0
GSK3390107A+Nimenrix 1-5YOAGroup	2.9
Nimenrix+GSK3390107A 1-5YOA Group	0

Lymphocytes, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	99.0
Nimenrix+GSK3390107A 13-17YOA Group	99.0
GSK3390107A+Nimenrix 6-12YOA Group	100.0
Nimenrix+GSK3390107A 6-12YOA Group	98.9
GSK3390107A+Nimenrix 1-5YOAGroup	95.6
Nimenrix+GSK3390107A 1-5YOA Group	100.0

Percentage of Subjects With Haematological Laboratory Abnormalities, Overall Primary · At Day 6.

RBC, Low

Group	Value	95% CI
GSK3390107A+Nimenrix Group	7.0
Nimenrix+GSK3390107A Group	5.5

RBC, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix Group	83.6
Nimenrix+GSK3390107A Group	84.0

RBC, High

Group	Value	95% CI
GSK3390107A+Nimenrix Group	9.4
Nimenrix+GSK3390107A Group	10.5

Neutrophils, Low

Group	Value	95% CI
GSK3390107A+Nimenrix Group	19.9
Nimenrix+GSK3390107A Group	14.8

Neutrophils, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix Group	79.3
Nimenrix+GSK3390107A Group	84.8

Neutrophils, High

Group	Value	95% CI
GSK3390107A+Nimenrix Group	0.8
Nimenrix+GSK3390107A Group	0.4

Lymphocytes, Low

Group	Value	95% CI
GSK3390107A+Nimenrix Group	1.2
Nimenrix+GSK3390107A Group	0.8

Lymphocytes, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix Group	97.7
Nimenrix+GSK3390107A Group	97.3

Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum Primary · 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.

RBC, Low

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	12.1
Nimenrix+GSK3390107A 13-17YOA Group	8.2
GSK3390107A+Nimenrix 6-12YOA Group	2.2
Nimenrix+GSK3390107A 6-12YOA Group	3.3
GSK3390107A+Nimenrix 1-5YOA Group	5.9
Nimenrix+GSK3390107A 1-5YOA Group	4.5

RBC, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	74.7
Nimenrix+GSK3390107A 13-17YOA Group	82.7
GSK3390107A+Nimenrix 6-12YOA Group	88.8
Nimenrix+GSK3390107A 6-12YOA Group	82.4
GSK3390107A+Nimenrix 1-5YOA Group	89.7
Nimenrix+GSK3390107A 1-5YOA Group	88.1

RBC, High

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	13.1
Nimenrix+GSK3390107A 13-17YOA Group	9.2
GSK3390107A+Nimenrix 6-12YOA Group	9.0
Nimenrix+GSK3390107A 6-12YOA Group	14.3
GSK3390107A+Nimenrix 1-5YOA Group	4.4
Nimenrix+GSK3390107A 1-5YOA Group	7.5

Neutrophils, Low

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	37.4
Nimenrix+GSK3390107A 13-17YOA Group	29.6
GSK3390107A+Nimenrix 6-12YOA Group	6.7
Nimenrix+GSK3390107A 6-12YOA Group	6.6
GSK3390107A+Nimenrix 1-5YOA Group	11.8
Nimenrix+GSK3390107A 1-5YOA Group	4.5

Neutrophils, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	61.6
Nimenrix+GSK3390107A 13-17YOA Group	69.4
GSK3390107A+Nimenrix 6-12YOA Group	92.1
Nimenrix+GSK3390107A 6-12YOA Group	93.4
GSK3390107A+Nimenrix 1-5YOA Group	88.2
Nimenrix+GSK3390107A 1-5YOA Group	95.5

Neutrophils, High

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	1.0
Nimenrix+GSK3390107A 13-17YOA Group	1.0
GSK3390107A+Nimenrix 6-12YOA Group	1.1
Nimenrix+GSK3390107A 6-12YOA Group	0
GSK3390107A+Nimenrix 1-5YOA Group	0
Nimenrix+GSK3390107A 1-5YOA Group	0

Lymphocytes, Low

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	1.0
Nimenrix+GSK3390107A 13-17YOA Group	0
GSK3390107A+Nimenrix 6-12YOA Group	0
Nimenrix+GSK3390107A 6-12YOA Group	0
GSK3390107A+Nimenrix 1-5YOA Group	2.9
Nimenrix+GSK3390107A 1-5YOA Group	3.0

Lymphocytes, Normal

Group	Value	95% CI
GSK3390107A+Nimenrix 13-17YOA Group	97.0
Nimenrix+GSK3390107A 13-17YOA Group	95.9
GSK3390107A+Nimenrix 6-12YOA Group	98.9
Nimenrix+GSK3390107A 6-12YOA Group	98.9
GSK3390107A+Nimenrix 1-5YOA Group	97.1
Nimenrix+GSK3390107A 1-5YOA Group	97.0

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK3390107A+Nimenrix Group

Serious: 2/300 (1%)

Deaths: 1/300

Nimenrix+GSK3390107A Group

Serious: 3/300 (1%)

Deaths: 0/300

Serious adverse events (5 terms)

Reaction	System	GSK3390107A+Nimenrix Group	Nimenrix+GSK3390107A Group
APPENDICITIS PERFORATED	Infections and infestations	—	—
HEPATITIS B	Infections and infestations	—	—
HEPATITIS D	Infections and infestations	—	—
MALARIA	Infections and infestations	—	—
DEATH	General disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	GSK3390107A+Nimenrix Group	Nimenrix+GSK3390107A Group
PAIN	General disorders	—	—
PYREXIA	General disorders	—	—
HEADACHE	Nervous system disorders	—	—
FATIGUE	General disorders	—	—
SOMNOLENCE	Nervous system disorders	—	—
DECREASED APPETITE	Metabolism and nutrition disorders	—	—
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	—	—

Most-reported serious reactions: APPENDICITIS PERFORATED, HEPATITIS B, HEPATITIS D, MALARIA, DEATH.

Data from ClinicalTrials.gov NCT02548078 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

New Vaccine Technologies to Combat Outbreak Situations.
Rauch S, Jasny E, Schmidt KE, Petsch B. · · 2018 · cited 380× · PMID 30283434 · DOI 10.3389/fimmu.2018.01963
Adenovirus-based vaccines-a platform for pandemic preparedness against emerging viral pathogens.
Coughlan L, Kremer EJ, Shayakhmetov DM. · · 2022 · cited 47× · PMID 35092844 · DOI 10.1016/j.ymthe.2022.01.034
Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial.
Tapia MD, Sow SO, Mbaye KD, Thiongane A, et al · · 2020 · cited 40× · PMID 32199492 · DOI 10.1016/s1473-3099(20)30019-0
Ebola: Lessons on Vaccine Development.
Feldmann H, Feldmann F, Marzi A. · · 2018 · cited 40× · PMID 30200851 · DOI 10.1146/annurev-micro-090817-062414
Ebola vaccines in clinical trial: The promising candidates.
Wang Y, Li J, Hu Y, Liang Q, et al · · 2017 · cited 40× · PMID 27764560 · DOI 10.1080/21645515.2016.1225637
Vaccines against Ebola virus and Marburg virus: recent advances and promising candidates.
Suschak JJ, Schmaljohn CS. · · 2019 · cited 37× · PMID 31589088 · DOI 10.1080/21645515.2019.1651140
Ebola virus disease candidate vaccines under evaluation in clinical trials.
Martins KA, Jahrling PB, Bavari S, Kuhn JH. · · 2016 · cited 37× · PMID 27160784 · DOI 10.1080/14760584.2016.1187566
Vaccinia virus-based vector against infectious diseases and tumors.
Zhang Z, Dong L, Zhao C, Zheng P, et al · · 2021 · cited 33× · PMID 33606578 · DOI 10.1080/21645515.2020.1840887

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02548078 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 3 May 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02548078.

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NCT02548078

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (5 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)

Other recruiting trials for Virus Diseases

Other GlaxoSmithKline trials

Verify against primary sources