NCT01440387 is a Phase 3 clinical trial of FLULAVAL® QUADRIVALENT in Influenza, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01440387?

NCT01440387 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01440387?

Interventions in NCT01440387: FLULAVAL® QUADRIVALENT.

Is NCT01440387 still recruiting?

NCT01440387 is currently completed. Last updated 7 September 2018.

Are results published for NCT01440387?

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

Last reviewed 2018-09-07 · How we verify

NCT01440387

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

A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older

Completed Phase 3 Results posted Last updated 7 September 2018

What this trial tests

Phase 3 trial testing FLULAVAL® QUADRIVALENT in Influenza in 112 participants. Completed in 22 October 2011.

Timeline

30 September 2011

Primary endpoint
22 October 2011

22 October 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	112
Start date	30 September 2011
Primary completion	22 October 2011
Estimated completion	22 October 2011
Sites	1 location across Canada

Drugs / interventions tested

FLULAVAL® QUADRIVALENT — 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.

Humoral Immune Response in Terms of Hemagglutination Inhibition (HI) Antibodies Against Each of the 4 Vaccine Influenza Strains. Primary · At Day 0 and Day 21

Antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu B/Florida/4/06 (Yamagata), FluB/Bri/60/08 (Victoria), Flu A/CAL/7/09 (H1N1) and Flu A/Victoria/210/09 (H3N2) antigens.

Yamagata strain, Day 0

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	130.4	92.8 – 183.2
FLULAVAL QUADRIVALENT Elderly Group	57.3	44.3 – 74.0

Yamagata strain, Day 21

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	404.8	323.1 – 507.2
FLULAVAL QUADRIVALENT Elderly Group	355.5	263.5 – 479.5

Victoria strain, Day 0

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	92.8	66.5 – 129.4
FLULAVAL QUADRIVALENT Elderly Group	38.5	28.3 – 52.4

Victoria strain, Day 21

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	318.0	251.4 – 402.3
FLULAVAL QUADRIVALENT Elderly Group	237.8	179.7 – 314.9

H1N1 strain, Day 0

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	82.0	54.9 – 122.5
FLULAVAL QUADRIVALENT Elderly Group	25.0	17.3 – 36.0

H1N1 strain, Day 21

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	392.5	305.4 – 504.4
FLULAVAL QUADRIVALENT Elderly Group	223.5	157.0 – 318.1

H3N2 strain, Day 0

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	45.3	31.3 – 65.4
FLULAVAL QUADRIVALENT Elderly Group	23.2	16.4 – 32.8

H3N2 strain, Day 21

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	215.4	166.3 – 278.9
FLULAVAL QUADRIVALENT Elderly Group	160.1	115.7 – 221.4

Number of Subjects Who Were Seroprotected for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Primary · At Day 0 and Day 21

A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.

Yamagata strain, Day 0

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	48
FLULAVAL QUADRIVALENT Elderly Group	45

Yamagata strain, Day 21

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	56
FLULAVAL QUADRIVALENT Elderly Group	56

Victoria strain, Day 0

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	47
FLULAVAL QUADRIVALENT Elderly Group	31

Victoria strain, Day 21

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	56
FLULAVAL QUADRIVALENT Elderly Group	55

H1N1 strain, Day 0

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	44
FLULAVAL QUADRIVALENT Elderly Group	26

H1N1 strain, Day 21

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	55
FLULAVAL QUADRIVALENT Elderly Group	52

H3N2 strain, Day 0

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	34
FLULAVAL QUADRIVALENT Elderly Group	28

H3N2 strain, Day 21

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	54
FLULAVAL QUADRIVALENT Elderly Group	53

Number of Seroconverted Subjects for HI Antibodies Against Each of the 4 Vaccine Influenza Strains. Primary · At Day 21

A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.

Yamagata strain

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	20
FLULAVAL QUADRIVALENT Elderly Group	35

Victoria strain

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	19
FLULAVAL QUADRIVALENT Elderly Group	33

H1N1 strain

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	28
FLULAVAL QUADRIVALENT Elderly Group	34

H3N2 strain

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	27
FLULAVAL QUADRIVALENT Elderly Group	35

HI Antibody Seroconversion Factors (SCFs) Against Each of the 4 Vaccine Influenza Strains. Primary · At Day 21

SCFs were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains assessed were Yamagata, Victoria, H1N1 and H3N2 antigens.

Yamagata strain

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	3.1	2.4 – 4.0
FLULAVAL QUADRIVALENT Elderly Group	6.2	4.6 – 8.4

Victoria strain

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	3.4	2.5 – 4.6
FLULAVAL QUADRIVALENT Elderly Group	6.2	4.3 – 8.8

H1N1 strain

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	4.8	3.3 – 7.0
FLULAVAL QUADRIVALENT Elderly Group	8.9	5.8 – 13.7

H3N2 strain

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	4.8	3.5 – 6.6
FLULAVAL QUADRIVALENT Elderly Group	6.9	4.7 – 10.1

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Secondary · During the 4-day (Days 0-3) post-vaccination period

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 pain that prevented normal everyday activities. Grade 3 redness and swelling were defined as redness/swelling greater than 100 millimeters (mm). i.e. \>100mm.

Any Pain

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	41
FLULAVAL QUADRIVALENT Elderly Group	19

Grade 3 Pain

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	0
FLULAVAL QUADRIVALENT Elderly Group	0

Any Redness

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	1
FLULAVAL QUADRIVALENT Elderly Group	0

Grade 3 Redness

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	0
FLULAVAL QUADRIVALENT Elderly Group	0

Any Swelling

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	1
FLULAVAL QUADRIVALENT Elderly Group	2

Grade 3 Swelling

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	0
FLULAVAL QUADRIVALENT Elderly Group	0

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms. Secondary · During the 4-day (Days 0-3) post-vaccination period

Solicited general symptoms assessed were chest tightness, chills, cough, fatigue, headache, joint pain at other location, muscle pain, red eyes, sore throat, swelling of the face and fever \[oral temperature ≥ 38.0 degrees Celsius (°C)\]. 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 = oral temperature above 39.0°C

Any Chest tightness

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	0
FLULAVAL QUADRIVALENT Elderly Group	2

Grade 3 Chest tightness

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	0
FLULAVAL QUADRIVALENT Elderly Group	0

Related Chest tightness

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	0
FLULAVAL QUADRIVALENT Elderly Group	2

Any Chills

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	1
FLULAVAL QUADRIVALENT Elderly Group	5

Grade 3 Chills

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	0
FLULAVAL QUADRIVALENT Elderly Group	0

Related Chills

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	1
FLULAVAL QUADRIVALENT Elderly Group	5

Any Cough

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	3
FLULAVAL QUADRIVALENT Elderly Group	4

Grade 3 Cough

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	0
FLULAVAL QUADRIVALENT Elderly Group	0

Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). Secondary · During the 21-day (Days 0-20) post-vaccination period.

An unsolicited AE was defined as any AE (i.e. any 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) 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.

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	13
FLULAVAL QUADRIVALENT Elderly Group	12

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Secondary · During the entire study period (Day 0 - Day 20 after vaccination).

A serious adverse event was 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 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.

Group	Value	95% CI
FLULAVAL QUADRIVALENT Adult Group	0
FLULAVAL QUADRIVALENT Elderly Group	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious Adverse Events: During the entire study period (Days 0 - 20 after vaccination); Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Days 0-20) post-vaccination period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FLULAVAL QUADRIVALENT Adult Group

Serious: 0/56 (0%)

Deaths: —

FLULAVAL QUADRIVALENT Elderly Group

Serious: 0/56 (0%)

Deaths: —

Other adverse events (10 terms — click to expand)

Reaction	System	FLULAVAL QUADRIVALENT Adul…	FLULAVAL QUADRIVALENT Elde…
Pain	General disorders	—	—
Muscle pain	General disorders	—	—
Headache	General disorders	—	—
Fatigue	General disorders	—	—
Joint pain at other location	General disorders	—	—
Sore throat	General disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Chills	General disorders	—	—
Cough	General disorders	—	—
Red eyes	General disorders	—	—

Data from ClinicalTrials.gov NCT01440387 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline (GSK) Biologicals' investigational quadrivalent split virion influenza vaccine FLU-Q-QIV in adults 18 years of age and older.

Publications & conference data

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

A historically-controlled Phase III study in adults to characterize the acceptability of a process change for manufacturing inactivated quadrivalent influenza vaccine.
Jain VK, Chandrasekaran V, Wang L, Li P, et al · · 2014 · cited 5× · PMID 24606983 · DOI 10.1186/1471-2334-14-133

Verify or expand the search:

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Other GlaxoSmithKline trials

Trials by the same sponsor.

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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 NCT01440387 (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: 7 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/NCT01440387.

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