NCT01144299 is a Phase 3 clinical trial of Fluarix™/Influsplit SSW® in Influenza, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01144299?

NCT01144299 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01144299?

Interventions in NCT01144299: Fluarix™/Influsplit SSW®.

Is NCT01144299 still recruiting?

NCT01144299 is currently completed. Last updated 24 September 2018.

Are results published for NCT01144299?

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

Last reviewed 2018-09-24 · How we verify

NCT01144299

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 GSK Biologicals' Seasonal Influenza Vaccine in Adults

Completed Phase 3 Results posted Last updated 24 September 2018

What this trial tests

Phase 3 trial testing Fluarix™/Influsplit SSW® in Influenza in 114 participants. Completed in 10 July 2010.

Timeline

17 June 2010

Primary endpoint
10 July 2010

10 July 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	114
Start date	17 June 2010
Primary completion	10 July 2010
Estimated completion	10 July 2010
Sites	6 locations across Germany

Drugs / interventions tested

Fluarix™/Influsplit SSW® — full drug profile →

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.

Hemagglutination Inhibition (HI) Antibody Titer Primary · Day 0 and Day 21

Titers given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains

A/California (Day 0)

Group	Value	95% CI
Fluarix Adult Group	10.2	7.7 – 13.6
Fluarix Elderly Group	8.7	6.6 – 11.4

A/California (Day 21)

Group	Value	95% CI
Fluarix Adult Group	314.1	237.5 – 415.4
Fluarix Elderly Group	89.4	60.1 – 133.0

A/Victoria (Day 0)

Group	Value	95% CI
Fluarix Adult Group	15.2	11.6 – 20.0
Fluarix Elderly Group	10.5	8.3 – 13.3

A/Victoria (Day 21)

Group	Value	95% CI
Fluarix Adult Group	89.6	70.8 – 113.3
Fluarix Elderly Group	75.4	56.8 – 100.2

B/Brisbane (Day 0)

Group	Value	95% CI
Fluarix Adult Group	36.3	26.4 – 50.1
Fluarix Elderly Group	42.1	30.6 – 57.9

B/Brisbane (Day 21)

Group	Value	95% CI
Fluarix Adult Group	271.6	213.3 – 345.9
Fluarix Elderly Group	132.3	99.0 – 176.9

Number of Seroprotected Subjects Primary · Day 0 and Day 21

A seroprotected subject is a subject with a serum HI antibody titer ≥ 1:40

A/California (Day 0)

Group	Value	95% CI
Fluarix Adult Group	9
Fluarix Elderly Group	4

A/California (Day 21)

Group	Value	95% CI
Fluarix Adult Group	54
Fluarix Elderly Group	41

A/Victoria (Day 0)

Group	Value	95% CI
Fluarix Adult Group	14
Fluarix Elderly Group	7

A/Victoria (Day 21)

Group	Value	95% CI
Fluarix Adult Group	48
Fluarix Elderly Group	45

B/Brisbane (Day 0)

Group	Value	95% CI
Fluarix Adult Group	29
Fluarix Elderly Group	29

B/Brisbane (Day 21)

Group	Value	95% CI
Fluarix Adult Group	55
Fluarix Elderly Group	47

Number of Seroconverted Subjects Primary · Day 21

A seroconverted subject is a subject with a pre-vaccination serum HI titer \< 1:10 and a post-vaccination serum HI titer ≥ 1:40, or a pre-vaccination serum HI titer ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4

A/California

Group	Value	95% CI
Fluarix Adult Group	50
Fluarix Elderly Group	35

A/Victoria

Group	Value	95% CI
Fluarix Adult Group	35
Fluarix Elderly Group	36

B/Brisbane

Group	Value	95% CI
Fluarix Adult Group	33
Fluarix Elderly Group	18

Seroconversion Factor Primary · Day 21

Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains

A/California

Group	Value	95% CI
Fluarix Adult Group	30.8	21.8 – 43.5
Fluarix Elderly Group	10.3	7.0 – 15.2

A/Victoria

Group	Value	95% CI
Fluarix Adult Group	5.9	4.5 – 7.8
Fluarix Elderly Group	7.2	5.1 – 10.1

B/Brisbane

Group	Value	95% CI
Fluarix Adult Group	7.5	5.1 – 11.0
Fluarix Elderly Group	3.1	2.2 – 4.4

Seroprotection Power Primary · Day 21

Seroprotection power is defined as the number of subject who had a pre-vaccination titer \< 1:40 and a post-vaccination titer ≥ 1:40

A/California

Group	Value	95% CI
Fluarix Adult Group	45
Fluarix Elderly Group	37

A/Victoria

Group	Value	95% CI
Fluarix Adult Group	34
Fluarix Elderly Group	38

B/Brisbane

Group	Value	95% CI
Fluarix Adult Group	26
Fluarix Elderly Group	18

Number of Subjects Reporting Solicited Local Symptoms Secondary · During the 4-day (Day 0-3) post-vaccination period

Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.

Ecchymosis

Group	Value	95% CI
Fluarix Adult Group	3
Fluarix Elderly Group	0

Induration

Group	Value	95% CI
Fluarix Adult Group	9
Fluarix Elderly Group	9

Pain

Group	Value	95% CI
Fluarix Adult Group	40
Fluarix Elderly Group	17

Redness

Group	Value	95% CI
Fluarix Adult Group	10
Fluarix Elderly Group	15

Swelling

Group	Value	95% CI
Fluarix Adult Group	8
Fluarix Elderly Group	7

Number of Subjects Reporting Solicited General Symptoms Secondary · During the 4-day (Day 0-3) post-vaccination period

Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever.

Arthralgia

Group	Value	95% CI
Fluarix Adult Group	6
Fluarix Elderly Group	4

Fatigue

Group	Value	95% CI
Fluarix Adult Group	13
Fluarix Elderly Group	8

Headache

Group	Value	95% CI
Fluarix Adult Group	11
Fluarix Elderly Group	9

Myalgia

Group	Value	95% CI
Fluarix Adult Group	11
Fluarix Elderly Group	9

Shivering

Group	Value	95% CI
Fluarix Adult Group	5
Fluarix Elderly Group	3

Fever (Axillary)

Group	Value	95% CI
Fluarix Adult Group	1
Fluarix Elderly Group	0

Sweating

Group	Value	95% CI
Fluarix Adult Group	3
Fluarix Elderly Group	3

Number of Subjects Reporting Unsolicited Adverse Events (AE) Secondary · During the 21-day (Day 0-20) post-vaccination period

An AE is 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

Group	Value	95% CI
Fluarix Adult Group	12
Fluarix Elderly Group	6

Number of Subjects Reporting Serious Adverse Events (SAE) Secondary · During the entire study period (From Day 0 up to Day 21)

An SAE is any untoward medical occurrence that: results in death, is lifethreatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Group	Value	95% CI
Fluarix Adult Group	0
Fluarix Elderly Group	0

Adverse events — posted to ClinicalTrials.gov

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

Fluarix Adult Group

Serious: 0/60 (0%)

Deaths: —

Fluarix Elderly Group

Serious: 0/54 (0%)

Deaths: —

Other adverse events (12 terms — click to expand)

Reaction	System	Fluarix Adult Group	Fluarix Elderly Group
Pain	General disorders	—	—
Redness	General disorders	—	—
Fatigue	General disorders	—	—
Headache	General disorders	—	—
Myalgia	General disorders	—	—
Induration	General disorders	—	—
Swelling	General disorders	—	—
Arthralgia	General disorders	—	—
Shivering	General disorders	—	—
Ecchymosis	General disorders	—	—
Sweating	General disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—

Data from ClinicalTrials.gov NCT01144299 adverse events section.

Sponsor's own description

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2010-2011 season.

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 Fluarix™/Influsplit SSW®

Trials testing the same drug.

NCT00920374 — A Study for Evaluation of Immunogenicity and Reactogenicity of FluarixTM / Influsplit SSW® 2009/2010 in Adults · Phase 3 · completed

Other recruiting trials for Influenza

Currently open trials in the same condition.

NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT07496450 — A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults · Phase 3 · recruiting
NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 1 · recruiting
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 NCT01144299 (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: 24 September 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/NCT01144299.

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

NCT01144299

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of Fluarix™/Influsplit SSW®

Other recruiting trials for Influenza

Other GlaxoSmithKline trials

Verify against primary sources