NCT00545025 is a Phase 2 clinical trial of Influenza Vaccine GSK1247446A in Influenza, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00545025?

NCT00545025 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00545025?

Interventions in NCT00545025: Influenza Vaccine GSK1247446A, Fluarix™.

What condition does NCT00545025 study?

NCT00545025 studies Influenza, Influenza, Human.

Is NCT00545025 still recruiting?

NCT00545025 is currently completed. Last updated 26 June 2019.

Are results published for NCT00545025?

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

Last reviewed 2019-06-26 · How we verify

NCT00545025

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

Revaccination With Influenza Vaccine GSK1247446A

Completed Phase 2 Results posted Last updated 26 June 2019

What this trial tests

Phase 2 trial testing Influenza Vaccine GSK1247446A in Influenza in 243 participants. Completed in 12 December 2007.

Timeline

15 October 2007

Primary endpoint
12 December 2007

12 December 2007

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	243
Start date	15 October 2007
Primary completion	12 December 2007
Estimated completion	12 December 2007
Sites	1 location across Belgium

Drugs / interventions tested

Influenza Vaccine GSK1247446A — full drug profile →
Fluarix™ — full drug profile →

Conditions studied

Influenza — all drugs for Influenza →
Influenza, Human — all drugs for Influenza, Human →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 60, any sex, with Influenza or Influenza, Human. 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 Any, Grade 3 and Related Solicited Local Symptoms Primary · During a 7-day (Days 0-6) follow-up period after re-vaccination

Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal everyday activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms assessed were considered by the investigator as related to study vaccination.

Any Ecchymosis

Group	Value	95% CI
GSK1247446A Group	8
Fluarix Group	5

Ecchymosis > 50mm

Group	Value	95% CI
GSK1247446A Group	1
Fluarix Group	2

Any Pain

Group	Value	95% CI
GSK1247446A Group	143
Fluarix Group	57

Grade 3 Pain

Group	Value	95% CI
GSK1247446A Group	9
Fluarix Group	2

Any Redness

Group	Value	95% CI
GSK1247446A Group	24
Fluarix Group	10

Redness > 50mm

Group	Value	95% CI
GSK1247446A Group	2
Fluarix Group	1

Any Swelling

Group	Value	95% CI
GSK1247446A Group	29
Fluarix Group	13

Swelling > 50mm

Group	Value	95% CI
GSK1247446A Group	4
Fluarix Group	2

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Primary · During a 7-day (Days 0-6) follow-up after re-vaccination

Assessed solicited general symptoms were arthralgia, fatigue, fever \[oral temperature equal to or above ≥ 37.5 degrees Celsius (°C)\], headache, myalgia, nausea and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.

Any Arthralgia

Group	Value	95% CI
GSK1247446A Group	28
Fluarix Group	5

Grade 3 Arthralgia

Group	Value	95% CI
GSK1247446A Group	3
Fluarix Group	0

Related Arthralgia

Group	Value	95% CI
GSK1247446A Group	26
Fluarix Group	5

Any Fatigue

Group	Value	95% CI
GSK1247446A Group	72
Fluarix Group	12

Grade 3 Fatigue

Group	Value	95% CI
GSK1247446A Group	7
Fluarix Group	2

Related Fatigue

Group	Value	95% CI
GSK1247446A Group	71
Fluarix Group	10

Fever ≥37.5°C

Group	Value	95% CI
GSK1247446A Group	27
Fluarix Group	2

Fever >39.0°C

Group	Value	95% CI
GSK1247446A Group	0
Fluarix Group	0

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) Primary · During a 30-day (Days 0-29) follow-up period after re-vaccination

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 = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity. Related = unsolicited AE assessed by the investigator as causally related to the study vaccination.

Any AEs

Group	Value	95% CI
GSK1247446A Group	69
Fluarix Group	31

Grade 3 AEs

Group	Value	95% CI
GSK1247446A Group	16
Fluarix Group	10

Related AEs

Group	Value	95% CI
GSK1247446A Group	35
Fluarix Group	8

Number of Subjects With Any and Related Serious Adverse Events (SAEs) Primary · During the entire study period (Days 0-30)

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Related = SAE assessed by the investigator as causally related to the study vaccination.

Any SAEs

Group	Value	95% CI
GSK1247446A Group	0
Fluarix Group	1

Related SAEs

Group	Value	95% CI
GSK1247446A Group	0
Fluarix Group	0

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease. Secondary · At Days 0 and 21

Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL). The seropositivity cut-off assay was 1:10.

A/SOL, Day 0 [N=158, 82]

Group	Value	95% CI
GSK1247446A Group	41.0	32.2 – 52.3
Fluarix Group	43.0	29.7 – 62.1

A/SOL, Day 21 [N=159, 82]

Group	Value	95% CI
GSK1247446A Group	162.4	140.0 – 188.4
Fluarix Group	127.2	97.2 – 166.5

A/WIS, Day 0 [N=158, 82]

Group	Value	95% CI
GSK1247446A Group	83.2	71.3 – 97.1
Fluarix Group	78.9	61.2 – 101.8

A/WIS, Day 21 [N=159, 82]

Group	Value	95% CI
GSK1247446A Group	191.7	171.7 – 214.0
Fluarix Group	147.0	121.6 – 177.6

B/MAL, Day 0 [N=158, 82]

Group	Value	95% CI
GSK1247446A Group	107.3	89.3 – 128.8
Fluarix Group	75.7	57.6 – 99.4

B/MAL, Day 21 [N=159, 82]

Group	Value	95% CI
GSK1247446A Group	334.2	296.0 – 377.4
Fluarix Group	199.3	164.5 – 241.5

Number of Seroconverted Subjects Against 3 Strains of Influenza Disease. Secondary · At Day 21

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).

A/SOL

Group	Value	95% CI
GSK1247446A Group	73
Fluarix Group	30

A/WIS

Group	Value	95% CI
GSK1247446A Group	40
Fluarix Group	13

B/MAL

Group	Value	95% CI
GSK1247446A Group	61
Fluarix Group	23

Number of Seroprotected Subjects Against 3 Strains of Influenza Disease. Secondary · At Day 0 and 21

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).

A/SOL, Day 0 [N=158, 82]

Group	Value	95% CI
GSK1247446A Group	87
Fluarix Group	45

A/SOL, Day 21 [159, 82]

Group	Value	95% CI
GSK1247446A Group	155
Fluarix Group	75

A/WIS, Day 0 [N=158, 82]

Group	Value	95% CI
GSK1247446A Group	139
Fluarix Group	69

A/WIS, Day 21 [N=159, 82]

Group	Value	95% CI
GSK1247446A Group	159
Fluarix Group	80

B/MAL, Day 0 [N=158, 82]

Group	Value	95% CI
GSK1247446A Group	133
Fluarix Group	67

B/MAL, Day 21 [N=159, 82]

Group	Value	95% CI
GSK1247446A Group	159
Fluarix Group	82

Seroconversion Factor for HI Antibodies Against 3 Strains of Influenza Disease. Secondary · At Day 21

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/Solomon Islands (A/SOL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL).

A/SOL

Group	Value	95% CI
GSK1247446A Group	3.9	3.3 – 4.8
Fluarix Group	3.0	2.3 – 3.8

A/WIS

Group	Value	95% CI
GSK1247446A Group	2.3	2.1 – 2.6
Fluarix Group	1.9	1.6 – 2.2

B/MAL

Group	Value	95% CI
GSK1247446A Group	3.1	2.7 – 3.6
Fluarix Group	2.6	2.2 – 3.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Reports for solicited local and general symptoms were collected during the 7 (Days 0-6) days post revaccination. Reports for AEs were collected during the 30 (Days 0-29) days post revaccination and SAEs during the whole study period (Day 0 - Month 1).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK1247446A Group

Serious: 0/160 (0%)

Deaths: 0/160

Fluarix Group

Serious: 1/83 (1%)

Deaths: 0/83

Serious adverse events (1 terms)

Reaction	System	GSK1247446A Group	Fluarix Group
Cerebrovascular accident	Nervous system disorders	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	GSK1247446A Group	Fluarix Group
Pain	General disorders	—	—
Fatigue	General disorders	—	—
Headache	General disorders	—	—
Myalgia	General disorders	—	—
Shivering	General disorders	—	—
Swelling	General disorders	—	—
Arthralgia	General disorders	—	—
Fever	General disorders	—	—
Redness	General disorders	—	—
Nausea	General disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Headache	Nervous system disorders	—	—
Ecchymosis	General disorders	—	—

Most-reported serious reactions: Cerebrovascular accident.

Data from ClinicalTrials.gov NCT00545025 adverse events section.

Sponsor's own description

The protocol is designed to demonstrate the safety of influenza vaccine GSK1247446A after revaccination.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Influenza Vaccine GSK1247446A

Trials testing the same drug.

NCT00385840 — Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate · 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
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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 NCT00545025 (US National Library of Medicine, public domain)
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: 26 June 2019

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/NCT00545025.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing