Who is sponsoring NCT01788228?

NCT01788228 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01788228?

Interventions in NCT01788228: Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia).

What condition does NCT01788228 study?

NCT01788228 studies Influenza, Influenza Vaccines.

Is NCT01788228 still recruiting?

NCT01788228 is currently completed. Last updated 23 June 2020.

Are results published for NCT01788228?

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

Last reviewed 2020-06-23 · How we verify

NCT01788228

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

Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

Completed Phase 3 Results posted Last updated 23 June 2020

What this trial tests

Phase 3 trial testing Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) in Influenza in 50 participants. Completed in 25 February 2015.

Timeline

22 March 2013

Primary endpoint
27 March 2014

25 February 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	50
Start date	22 March 2013
Primary completion	27 March 2014
Estimated completion	25 February 2015
Sites	3 locations across United States

Drugs / interventions tested

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) — full drug profile →

Conditions studied

Influenza — all drugs for Influenza →
Influenza Vaccines — all drugs for Influenza Vaccines →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Influenza or Influenza Vaccines. 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 Reporting Any and Grade 3 Solicited Local Symptoms Overall and by Age Category (18-64 and >64 Years of Age). Primary · During a 7-day follow-up period (Days 0-6) after each vaccination

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm.

Any Pain

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	45
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	1
Influenza A (H5N1) Virus Monovalent Vaccine Group	46

Grade 3 Pain

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	4
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	4

Any Redness

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	6
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	6

Grade 3 Redness

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	0

Any Swelling

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	7
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	7

Grade 3 Swelling

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	0

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms Overall and by Age Category (18-64 and >64 Years of Age). Primary · During a 7-day follow-up period (Days 0-6) after each vaccination

Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache, joint pain, muscle ache, shivering, sweating and fever \[oral temperature above 38.0 degrees Celsius (°C)\]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature ≥ 39.0°C and ≤40°C.

Any Fatigue

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	27
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	27

Grade 3 Fatigue

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	1
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	1

Related Fatigue

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	26
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	26

Any Gastrointestinal symptoms

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	12
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	12

Grade 3 Gastrointestinal symptoms

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	2
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	2

Related Gastrointestinal symptoms

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	8
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	8

Any Headache

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	20
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	20

Grade 3 Headache

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	2
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	2

Number of Subjects Reporting Any Unsolicited AEs, Overall and by Age Category (18-64 and >64 Years of Age) Primary · During the 21-day (Days 0-20 post dose 1 and Days 21-41 post dose 2) post-vaccination period

Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Related was defined as an unsolicited symptom assessed as causally related to the study vaccination.

Any unsolicited AEs

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	10
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	10

Related unsolicited AEs

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	4
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine Group	4

Number of Subjects Reporting Any or Related Medically Attended Adverse Events (MAEs) Secondary · During the entire study period (Day 0 to Day 385)

MAEs refer to events that required medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Related = symptom assessed by the investigator as causally related to the study vaccination.

Any MAEs

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	9
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0

Related MAEs

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0

Number of Subjects Reporting Any and Related Potential Immune-Mediated Diseases (pIMDs) Secondary · During the entire study period (Day 0 to Day 385)

Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events (AEs) that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. Any was defined as occurrence of any pIMD regardless of intensity grade or relation to vaccination. Related was defined as pIMD(s) considered by the investigator to have a causal relationship to vaccination.

Any pIMDs

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0

Related pIMDs

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Secondary · During the entire study period (Day 0 to Day 385)

A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.

Any SAEs

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0

Related SAEs

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0

Number of Subjects With Reported Adverse Pregnancy Outcomes Secondary · During the entire study period (Day 0 to Day 385)

Any = Occurrence of any adverse pregnancy outcomes regardless of intensity grade or relation to study vaccination. Related = Adverse pregnancy outcomes assessed by the investigator as causally related to the study vaccination

Any adverse pregnancy outcome(s)

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0

Related adverse pregnancy outcomes

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group	0
Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group	0

Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores Secondary · Day 0 (baseline) and at each day from Day 1 to Day 7 post first vaccine dose

The assessed parameters for change from baseline were Physical functioning (PF), Physical-health related role limitations (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Emotional health related role limitations (RE), Mental health (MH) defined as subscale component, and physical (PCS) and mental (MCS) component defined as summary components, and Quality Adjusted Life Years (QALY). See methodology details in outcome 11 description. For all subscale components, scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life

PF : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-17.3500 – 28.9200

RP : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-17.6100 – 8.81

BP : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-30.7900 – 10.2600

GH : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	-1.3200	-16.7700 – 8.8200

VT : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-21.7700 – 21.7700

SF : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-19.7700 – 14.8200

RE : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-7.6400 – 11.4500

MH : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-22.3000 – 14.8700

Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Health 8-score Secondary · Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)

The assessed parameters for change from baseline were Physical functioning (PF), Physical-health related role limitations (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Emotional health related role limitations (RE), Mental health (MH) defined as subscale component. For all subscale components, scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life. Median and range of the change from baseline of the SF-36 score are presented for each component and time point. Analysis was carried out for all subjects regardless

PF : Day 7

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-1.93 – 28.92

PF : Day 21

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-7.71 – 28.92

PF : Day 28

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-5.78 – 28.92

RP: Day 7

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-17.61 – 8.81

RP: Day 21

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-15.41 – 8.81

RP: Day 28

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-17.61 – 8.81

BP: Day 7

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-26.85 – 19.34

BP: Day 21

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-15.00 – 23.29

Assessment of Changes From Baseline (Day 0) in the SF-36v2 Weekly Questionnaire General Health Scores (Physical and Mental) Secondary · Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)

The assessed parameters for change from baseline were physical and mental component defined as summary components (PCS and MCS) or general health scores (GHS). For all subscale component, scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life. Subscale component scores are averaged to compute the summary component score. Median and range of the change from baseline of the SF-36v2 score are presented for each summary component and time point. Analysis was carried out for all subjects regardless of age stratum.

PCS, Day 7

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-11.19 – 13.58

PCS, Day 21

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.180	-11.32 – 13.58

PCS, Day 28

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	-0.290	-6.36 – 13.58

MCS, Day 7

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.420	-11.08 – 11.83

MCS, Day 21

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.095	-5.10 – 7.33

MCS, Day 28

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-7.29 – 11.83

Assessment of Changes From Baseline (Day 0) for Quality Adjusted Life Years (QALY) Weekly Scores Secondary · Day 0 (baseline) and at Days 7 and 21 QoL evaluation (post dose 1) and Day 28 QoL evaluation (post dose 2)

The assessed parameters for change from baseline were QALY scores. The methodology used for the analysis of the SF-36v2 questionnaire was detailed in Ware et al \[Ware 2008\]. The QualityMetric Health Outcomes Scoring Software was used to generate a Quality of Life analysis dataset based on the SF-36 questionnaire. QoL data were transformed to generate Quality-Adjusted Life Years (QALY) scores. A standard algorithm was developed for processing subjects' answers and producing QALY scores. For all subscale components, scores range from 0 to 100, with high scores indicating high levels of functio

QALY score : Day 7

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-0.25 – 0.33

QALY score : Day 21

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-0.25 – 0.33

QALY score : Day 28

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.000	-0.19 – 0.33

Assessment of Changes From Baseline (Day 0) in the SF-36v2 Daily Questionnaire Subscale Component, Summary Component and QALY Scores for Subjects Who Reported at Least One Local or General Solicited AE Post First Vaccination. Secondary · Day 0 (baseline) and at each day from Day 1 to Day 7 post first vaccine dose

The assessed parameters for change from baseline were Physical functioning (PF), Physical-health related role limitations (RP), Bodily pain (BP), General health (GH), Vitality (VT), Social functioning (SF), Emotional health related role limitations (RE), Mental health (MH) defined as subscale component, and physical (PCS) and mental (MCS) component defined as summary components, and Quality Adjusted Life Years (QALY). For all subscale component, scores range from 0 to 100, with high scores indicating high levels of functioning/quality of life. Subscale component scores are averaged to compute

PF : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-17.3500 – 28.9200

RP : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-17.6100 – 8.81

BP : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	-0.7900	-30.7900 – 8.6800

GH : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	-1.3200	-16.7700 – 8.8200

VT : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-21.7700 – 21.7700

SF : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-19.7700 – 14.8200

RE : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-7.6400 – 11.4500

MH : Day 1

Group	Value	95% CI
Influenza A (H5N1) Virus Monovalent Vaccine Group	0.0000	-22.3000 – 14.8700

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious Adverse Events: From Day 0 up to Day 385; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period after each vaccination; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period after each vaccination. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group

Serious: 0/49 (0%)

Deaths: 0/49

Influenza A (H5N1)Virus Monovalent Vaccine ˃64 Years Group

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (10 terms — click to expand)

Reaction	System	Influenza A (H5N1) Virus M…	Influenza A (H5N1)Virus Mo…
Pain	General disorders	—	—
Muscle ache	General disorders	—	—
Fatigue	General disorders	—	—
Headache	General disorders	—	—
Joint pain	General disorders	—	—
Gastrointestinal symptoms	General disorders	—	—
Shivering	General disorders	—	—
Swelling	General disorders	—	—
Sweating	General disorders	—	—
Redness	General disorders	—	—

Data from ClinicalTrials.gov NCT01788228 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals' vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk of exposure to the virus.

Publications & conference data

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

Pandemic preparedness through vaccine development for avian influenza viruses.
Cargnin Faccin F, Perez DR. · · 2024 · cited 34× · PMID 38807261 · DOI 10.1080/21645515.2024.2347019
Usability of daily SF36 questionnaires to capture the QALD variation experienced after vaccination with AS03<sub>A</sub>-adjuvanted monovalent influenza A (H5N1) vaccine in a safety and tolerability study.
Standaert B, Dort T, Linden J, Madan A, et al · · 2019 · cited 7× · PMID 31060567 · DOI 10.1186/s12955-019-1147-4

Verify or expand the search:

Other trials of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)

Trials testing the same drug.

NCT00719043 — Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years · Phase 2 · completed

Other recruiting trials for Influenza

Currently open trials in the same condition.

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NCT07431840 — Immune Defense Protein Impact On Respiratory Immune Outcomes · NA · recruiting
NCT07485855 — Influenza Vaccination Strategy for Patients With Hematologic Malignancy · Phase 3 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

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 NCT01788228 (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: 23 June 2020

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/NCT01788228.

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