NCT00719043 is a Phase 2 clinical trial of A/turkey H5N1 vaccine in Influenza, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00719043?

NCT00719043 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00719043?

Interventions in NCT00719043: A/turkey H5N1 vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia), Placebo.

Is NCT00719043 still recruiting?

NCT00719043 is currently completed. Last updated 9 July 2018.

Are results published for NCT00719043?

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

Last reviewed 2018-07-09 · How we verify

NCT00719043

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

Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years

Completed Phase 2 Results posted Last updated 9 July 2018

What this trial tests

Phase 2 trial testing A/turkey H5N1 vaccine in Influenza in 841 participants. Completed in 18 February 2011.

Timeline

11 July 2008

Primary endpoint
22 April 2010

18 February 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	841
Start date	11 July 2008
Primary completion	22 April 2010
Estimated completion	18 February 2011
Sites	13 locations across Canada, United States

Drugs / interventions tested

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

Conditions studied

Influenza — all drugs for Influenza →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

18 and older, any sex, with Influenza. 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 Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. Primary · At Day 559

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 549. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N

Group	Value	95% CI
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	71
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	81
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	73
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group	65

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. Primary · At Day 192

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group

Group	Value	95% CI
Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group	44

Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. Primary · At Days 549 and 559

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

A/turkey, Day 549 (N=83,88,81,72)

Group	Value	95% CI
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	11.1	8.8 – 14.1
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	8.3	7.0 – 9.7
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	9.2	7.6 – 11.2
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group	11.4	9.1 – 14.4

A/turkey, Day 559 (N= 83,88,81,72)

Group	Value	95% CI
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	356.7	265.9 – 478.5
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	266.4	202.2 – 351.2
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	446.6	336.0 – 593.7
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group	343.9	254.2 – 465.3

Haemagglutination Inhibition (HI) Antibody Titers Against the A/Turkey/Turkey/1/2005 (A/Turkey) Strain. Primary · At Days 182 and 192

HI antibody titers against the A/turkey virus strain were expressed as geometric mean titers (GMTs). This outcome concerns solely subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

A/turkey strain, Day 182 (N=100)

Group	Value	95% CI
Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group	10.8	8.4 – 13.9

A/turkey strain, Day 192 (N=99)

Group	Value	95% CI
Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group	43.5	32.6 – 58.0

Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. Primary · At Days 549 and 559

A seroprotected subject was defined as a vaccinated subject with HI antibody titers against the A/turkey virus strain greater than or equal to (≥) 1:40. This outcome concerns solely subjects in the Pumarix Primed-Placebo-A/turkey H5N1-Formulation 3, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 1, Pumarix Primed-Placebo-A/turkey H5N1-Formulation 4 and Pumarix Primed-Placebo-A/turkey H5N1-Formulation 2 groups.

A/turkey, Day 549 (N=83,88,81,72)

Group	Value	95% CI
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	15
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	8
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	10
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group	13

A/turkey, Day 559 (N= 83,87,80,72)

Group	Value	95% CI
A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group	79
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group	83
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group	77
A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group	69

Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. Primary · At Days 182 and 192

A/turkey strain, Day 182 (N=100)

Group	Value	95% CI
Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group	24

A/turkey strain, Day 192 (N=99)

Group	Value	95% CI
Naïve Placebo-A/Turkey Influenza (H5N1)-F3-Group	64

Number of Subjects With Solicited Local Symptoms Primary · Within the 7-day (Days 0-6) post vaccination periods

Assessed solicited local symptoms were pain, redness and swelling. Any was defined as an occurrence of the specified solicited local symptom regardless of its intensity.

Any Pain

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	98
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	100
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	101
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	93
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	102
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	90
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	95

Any Redness

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	8
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	4
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	12
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	9
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	14
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	4
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	8

Any Swelling

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	6
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	7
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	15
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	4
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	16
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	9
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	11

Number of Subjects With Solicited General Symptoms Primary · Within the 7-day (Days 0-6) post vaccination periods

Solicited general symptoms assessed were fatigue, headache, joint pain at other locations (joint pain), muscle aches, shivering, sweating and fever. Any was defined as an occurrence of the specified solicited general symptom, irrespective of its intensity or relationship to vaccination. Any fever was defined as oral temperature higher than or equal to (≥) 38.0 degrees Celsius (°C).

Any Fatigue

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	45
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	50
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	47
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	44
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	42
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	39
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	47

Any Headache

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	44
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	50
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	42
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	44
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	44
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	35
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	47

Any Joint pain

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	33
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	37
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	36
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	26
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	28
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	16
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	30

Any Muscle aches

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	54
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	52
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	59
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	49
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	48
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	42
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	55

Any Shivering

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	12
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	18
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	16
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	8
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	20
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	10
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	18

Any Sweating

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	15
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	20
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	15
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	11
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	14
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	10
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	11

Any Fever

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	2
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	5
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	6
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	3
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	8
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	2
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	2

Number of Subjects With Medically-attended Adverse Events (MAEs) Primary · From Day 0 to Day 909

MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	68
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	66
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	77
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	75
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	62
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	63
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	70

Number of Subjects With Unsolicited Adverse Events (AEs) Primary · Within the 43-day (Days 0-42) post-vaccination periods

An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with 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 any occurrence of an unsolicited AE in a subject, regardless of intensity grade or relation to vaccination.

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	70
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	72
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	78
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	68
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	67
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	68
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	75

Number of Subjects With Serious Adverse Events (SAEs) Primary · From Day 0 to Day 909

A SAE was defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as an occurrence of an SAE, regardless its relationship to vaccination.

Group	Value	95% CI
Pumarix Primed-A/Turkey H5N1-Formulation 1-Placebo Group	12
Pumarix Primed-A/Turkey H5N1-Formulation 2-Placebo Group	14
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 3 Group	11
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 1 Group	9
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 4 Group	11
Pumarix Primed-Placebo-A/Turkey H5N1-Formulation 2 Group	15
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	12

Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against the A/Turkey/Turkey/1/2005 (A/Turkey) Virus Strain. Secondary · At Day 192

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination reciprocal titer greater than or equal to (≥) 1:40 or a pre-vaccination reciprocal titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. Pre-vaccination for this outcome measure corresponds to Day 182. This outcome measure solely concerns subjects in the Naïve Placebo-A/turkey H5N1-Formulation 3 Group.

Group	Value	95% CI
Naïve Placebo-A/Turkey H5N1-Formulation 3 Group	44

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious adverse events (SAEs): From Day 0 to Day 909; Solicited local and general symptoms: During the 7-day (Days 0-6) post vaccination periods; Unsolicited adverse events: During the 43-day (Days 0-42) post vaccination periods.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

A/Indonesia Primed-A/Turkey Influenza (H5N1)-F1-Placebo Group

Serious: 12/120 (10%)

Deaths: —

A/Indonesia Primed-A/Turkey Influenza (H5N1)-F2-Placebo Group

Serious: 14/121 (12%)

Deaths: —

A/Indonesia Primed-A/Turkey Influenza (H5N1)-F3-Placebo Group

Serious: 11/119 (9%)

Deaths: —

A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F1-Group

Serious: 9/119 (8%)

Deaths: —

A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F4-Group

Serious: 11/122 (9%)

Deaths: —

A/Indonesia Primed-Placebo-A/Turkey Influenza (H5N1)-F2-Group

Serious: 15/120 (13%)

Deaths: —

Naïve Placebo-A/Turkey H5N1-Formulation 3 Group

Serious: 12/120 (10%)

Deaths: —

Serious adverse events (95 terms)

Reaction	System	A/Indonesia Primed-A/Turke…	A/Indonesia Primed-A/Turke…	A/Indonesia Primed-A/Turke…	A/Indonesia Primed-Placebo…	A/Indonesia Primed-Placebo…	A/Indonesia Primed-Placebo…	Naïve Placebo-A/Turkey H5N…
Cerebrovascular accident	Nervous system disorders	—	—	—	—	—	—	—
Nephrolithiasis	Renal and urinary disorders	—	—	—	—	—	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—	—	—	—
Bradycardia	Cardiac disorders	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—
Chest discomfort	General disorders	—	—	—	—	—	—	—
Coronary artery disease	Cardiac disorders	—	—	—	—	—	—	—
Endometriosis	Reproductive system and breast disorders	—	—	—	—	—	—	—
Loss of consciousness	Nervous system disorders	—	—	—	—	—	—	—
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Syncope	Nervous system disorders	—	—	—	—	—	—	—
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—	—	—	—	—	—
Abortion spontaneous incomplete	Pregnancy, puerperium and perinatal conditions	—	—	—	—	—	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Amnesia	Nervous system disorders	—	—	—	—	—	—	—
Anaphylactic shock	Immune system disorders	—	—	—	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—	—	—	—
Ankle fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—	—
Arteriosclerosis	Vascular disorders	—	—	—	—	—	—	—
Arteriosclerosis coronary artery	Cardiac disorders	—	—	—	—	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—	—	—	—	—
Bipolar disorder	Psychiatric disorders	—	—	—	—	—	—	—

Other adverse events (17 terms — click to expand)

Reaction	System	A/Indonesia Primed-A/Turke…	A/Indonesia Primed-A/Turke…	A/Indonesia Primed-A/Turke…	A/Indonesia Primed-Placebo…	A/Indonesia Primed-Placebo…	A/Indonesia Primed-Placebo…	Naïve Placebo-A/Turkey H5N…
Pain	General disorders	—	—	—	—	—	—	—
Muscle aches	General disorders	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—
Headache	General disorders	—	—	—	—	—	—	—
Joint pain	General disorders	—	—	—	—	—	—	—
Shivering	General disorders	—	—	—	—	—	—	—
Sweating	General disorders	—	—	—	—	—	—	—
Swelling	General disorders	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—
Redness	General disorders	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Fever	General disorders	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—

Most-reported serious reactions: Cerebrovascular accident, Nephrolithiasis, Breast cancer, Pneumonia, Appendicitis, Pancreatitis, Bradycardia, Bronchitis.

Data from ClinicalTrials.gov NCT00719043 adverse events section.

Sponsor's own description

The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic and safe when given to adults aged \>=18 years. This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009. The impacted sections are study design and outcome measures.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Heterologous prime-boost with A(H5N1) pandemic influenza vaccines induces broader cross-clade antibody responses than homologous prime-boost.
Levine MZ, Holiday C, Jefferson S, Gross FL, et al · · 2019 · cited 31× · PMID 31149353 · DOI 10.1038/s41541-019-0114-8

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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 NCT00719043 (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: 9 July 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/NCT00719043.

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NCT00719043

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 (95 terms)

Sponsor's own description

Publications & conference data

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