NCT00989287 is a Phase 3 clinical trial of GSK2340272A in Influenza, sponsored by GlaxoSmithKline.

Who is sponsoring NCT00989287?

NCT00989287 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT00989287?

Interventions in NCT00989287: GSK2340272A, GSK2340269A.

Is NCT00989287 still recruiting?

NCT00989287 is currently completed. Last updated 26 June 2019.

Are results published for NCT00989287?

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

NCT00989287

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

Immunogenicity and Safety Study of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults

Completed Phase 3 Results posted Last updated 26 June 2019

What this trial tests

Phase 3 trial testing GSK2340272A in Influenza in 131 participants. Completed in 26 October 2010.

Timeline

7 October 2009

Primary endpoint
9 October 2009

26 October 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	131
Start date	7 October 2009
Primary completion	9 October 2009
Estimated completion	26 October 2010
Sites	1 location across Belgium

Drugs / interventions tested

GSK2340272A — full drug profile →
GSK2340269A — full drug profile →

Conditions studied

Influenza — all drugs for Influenza →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 60, 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 (SCR) Subjects for Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain Primary · At Day 21

Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 10 post-vaccination\], antibody titer greater than or equal to (≥) 40 after vaccination; For initially seropositive subjects (antibody titer ≥ 10 prior to vaccination), antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was A/California/7/2009 (H1N1)v-like influenza (Flu A/CAL/7/09).

Group	Value	95% CI
GSK2340272A Group	60
GSK2340269A Group	44

Number of Subjects Who Were Seroprotected (SPR) for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Primary · At Day 21

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40, that usually is accepted as indicating protection.

Group	Value	95% CI
GSK2340272A Group	60
GSK2340269A Group	46

Geometric Mean Fold Change (GMFR) for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease Primary · At Day 21

GMFR was defined as the fold change in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.

Group	Value	95% CI
GSK2340272A Group	44.4	33.6 – 58.7
GSK2340269A Group	11.4	8.1 – 16.3

Number of Subjects Who Were Seropositive for Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Secondary · At Days 0, 21 and 42

A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.

Flu A/CAL/7/09, Day 0

Group	Value	95% CI
GSK2340272A Group	29
GSK2340269A Group	20

Flu A/CAL/7/09, Day 21

Group	Value	95% CI
GSK2340272A Group	29
GSK2340269A Group	20

Flu A/CAL/7/09, Day 42

Group	Value	95% CI
GSK2340272A Group	29
GSK2340269A Group	20

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease Secondary · At Days 0, 21 and 42

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

Flu A/CAL/7/09, Day 0

Group	Value	95% CI
GSK2340272A Group	9.6	7.6 – 12.0
GSK2340269A Group	8.4	6.7 – 10.6

Flu A/CAL/7/09, Day 21

Group	Value	95% CI
GSK2340272A Group	424.0	312.4 – 575.5
GSK2340269A Group	96.4	64.0 – 145.3

Flu A/CAL/7/09, Day 42

Group	Value	95% CI
GSK2340272A Group	686.7	567.0 – 831.7
GSK2340269A Group	149.7	108.0 – 207.7

Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain Secondary · At Days 0, 21 and 42

A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection.

Flu A/CAL/7/09, Day 0

Group	Value	95% CI
GSK2340272A (18-40y)	17
GSK2340269A (18-40y)	13
GSK2340272A (41-60y)	12
GSK2340269A (41-60y)	7
GSK2340272A (41-50y)	4
GSK2340269A (41-50y)	5
GSK2340272A (51-60y)	8
GSK2340269A (51-60y)	2

Flu A/CAL/7/09, Day 21

Group	Value	95% CI
GSK2340272A (18-40y)	17
GSK2340269A (18-40y)	13
GSK2340272A (41-60y)	12
GSK2340269A (41-60y)	7
GSK2340272A (41-50y)	4
GSK2340269A (41-50y)	5
GSK2340272A (51-60y)	8
GSK2340269A (51-60y)	2

Flu A/CAL/7/09, Day 42

Group	Value	95% CI
GSK2340272A (18-40y)	17
GSK2340269A (18-40y)	13
GSK2340272A (41-60y)	12
GSK2340269A (41-60y)	7
GSK2340272A (41-50y)	4
GSK2340269A (41-50y)	5
GSK2340272A (51-60y)	8
GSK2340269A (51-60y)	2

Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease Secondary · At Days 0, 21 and 42

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

Flu A/CAL/7/09, Day 0

Group	Value	95% CI
GSK2340272A (18-40y)	12.4	8.2 – 18.7
GSK2340269A (18-40y)	10.9	7.2 – 16.5
GSK2340272A (41-60y)	7.4	6.1 – 8.9
GSK2340269A (41-60y)	6.5	5.3 – 8.1
GSK2340272A (41-50y)	6.3	5.0 – 8.1
GSK2340269A (41-50y)	7.5	5.1 – 11.2
GSK2340272A (51-60y)	8.6	6.3 – 11.7
GSK2340269A (51-60y)	5.7	4.7 – 6.9

Flu A/CAL/7/09, Day 21

Group	Value	95% CI
GSK2340272A (18-40y)	705.7	523.8 – 950.7
GSK2340269A (18-40y)	171.1	96.7 – 302.8
GSK2340272A (41-60y)	254.8	156.7 – 414.4
GSK2340269A (41-60y)	55.4	32.0 – 95.7
GSK2340272A (41-50y)	287.1	164.1 – 502.1
GSK2340269A (41-50y)	123.3	59.5 – 255.5
GSK2340272A (51-60y)	226.2	95.3 – 536.6
GSK2340269A (51-60y)	24.8	12.9 – 47.9

Flu A/CAL/7/09, Day 42

Group	Value	95% CI
GSK2340272A (18-40y)	895.4	714.7 – 1121.8
GSK2340269A (18-40y)	216.2	134.8 – 346.8
GSK2340272A (41-60y)	526.7	393.1 – 705.6
GSK2340269A (41-60y)	104.9	67.4 – 163.2
GSK2340272A (41-50y)	462.5	340.9 – 627.5
GSK2340269A (41-50y)	170.8	94.4 – 308.8
GSK2340272A (51-60y)	599.7	352.3 – 1020.8
GSK2340269A (51-60y)	64.4	34.6 – 120.0

Number of Subjects Who Were Seropositive for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Secondary · At Days 182 and 364

A seropositive subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:10, that usually is accepted as indicating protection.

Flu A/CAL/7/09, Day 182

Group	Value	95% CI
GSK2340272A Group	64
GSK2340269A Group	59

Flu A/CAL/7/09, Day 364

Group	Value	95% CI
GSK2340272A Group	60
GSK2340269A Group	49

Titers for Serum HI Antibodies Against the Flu A/California/7/2009 (H1N1) Strain of Influenza Disease Secondary · At Days 182 and 364

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was greater than or equal to (≥) 1:10.

Flu A/CAL/7/09, Day 182

Group	Value	95% CI
GSK2340272A Group	222.6	172.4 – 287.4
GSK2340269A Group	80.4	55.1 – 117.2

Flu A/CAL/7/09, Day 364

Group	Value	95% CI
GSK2340272A Group	76.8	58.1 – 101.5
GSK2340269A Group	35.2	24.0 – 51.7

Number of Subjects Who Were Seropositive for HI Antibodies Against Flu A/California/7/2009 (H1N1) Virus Strain Secondary · At Days 182 and 364

A seropositive subject was defined as a vaccinated subject with a serum HI titer ≥ 1:10, that usually is accepted as indicating protection.

Flu A/CAL/7/09, Day 182

Group	Value	95% CI
GSK2340272A (18-40y)	32
GSK2340269A (18-40y)	29
GSK2340272A (41-50y)	16
GSK2340269A (41-50y)	16
GSK2340272A (51-60y)	16
GSK2340269A (51-60y)	14

Flu A/CAL/7/09, Day 364

Group	Value	95% CI
GSK2340272A (18-40y)	30
GSK2340269A (18-40y)	26
GSK2340272A (41-50y)	16
GSK2340269A (41-50y)	14
GSK2340272A (51-60y)	14
GSK2340269A (51-60y)	9

Titers for Serum HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease Secondary · At Days 182 and 364

Titers are presented as geometric mean titers (GMTs). The flu strain assessed was Flu A/CAL/7/09. The reference seropositivity cut-off value was ≥ 1:10.

Flu A/CAL/7/09, Day 182

Group	Value	95% CI
GSK2340272A (18-40y)	269.1	183.9 – 393.9
GSK2340269A (18-40y)	132.3	75.9 – 230.4
GSK2340272A (41-50y)	182.2	126.8 – 261.7
GSK2340269A (41-50y)	99.3	47.8 – 206.6
GSK2340272A (51-60y)	186.1	97.5 – 355.4
GSK2340269A (51-60y)	24.8	15.6 – 39.6

Flu A/CAL/7/09, Day 364

Group	Value	95% CI
GSK2340272A (18-40y)	96.2	63.1 – 146.7
GSK2340269A (18-40y)	57.2	32.2 – 101.8
GSK2340272A (41-50y)	57.7	38.4 – 86.8
GSK2340269A (41-50y)	48.4	23.2 – 101.1
GSK2340272A (51-60y)	66.4	33.1 – 133.2
GSK2340269A (51-60y)	10.6	6.8 – 16.7

Number of Seroconverted (SCR) Subjects for HI Antibodies Against Flu A/California/7/2009 (H1N1) Strain of Influenza Disease Secondary · At Days 21 and 42

Flu A/CAL/7/09, Day 21

Group	Value	95% CI
GSK2340272A (18-40y)	32
GSK2340269A (18-40y)	25
GSK2340272A (41-50y)	16
GSK2340269A (41-50y)	12
GSK2340272A (51-60y)	12
GSK2340269A (51-60y)	7

Flu A/CAL/7/09, Day 42

Group	Value	95% CI
GSK2340272A (18-40y)	32
GSK2340269A (18-40y)	27
GSK2340272A (41-50y)	16
GSK2340269A (41-50y)	15
GSK2340272A (51-60y)	16
GSK2340269A (51-60y)	12

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local and general symptoms: during the 7-day (Days 0-6) post-vaccination period; Unsolicited AEs: within the 84-day (Days 0-83) post-vaccination period; SAEs: during the entire study period (from Day 0 up to Day 364).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK2340272A Group

Serious: 4/65 (6%)

Deaths: 0/65

GSK2340269A Group

Serious: 4/66 (6%)

Deaths: 0/66

Serious adverse events (12 terms)

Reaction	System	GSK2340272A Group	GSK2340269A Group
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Abortion spontaneous complete	Pregnancy, puerperium and perinatal conditions	—	—
Balance disorder	Nervous system disorders	—	—
Benign prostatic hyperplasia	Reproductive system and breast disorders	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Calculus ureteric	Renal and urinary disorders	—	—
Nephrolithiasis	Renal and urinary disorders	—	—
Renal disorder	Renal and urinary disorders	—	—
Ligament rupture	Injury, poisoning and procedural complications	—	—
Open wound	Injury, poisoning and procedural complications	—	—
Radius fracture	Injury, poisoning and procedural complications	—	—
Sepsis	Infections and infestations	—	—

Other adverse events (19 terms — click to expand)

Reaction	System	GSK2340272A Group	GSK2340269A Group
Pain	General disorders	—	—
Headache	Nervous system disorders	—	—
Fatigue	General disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Muscle aches	General disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Joint Pain ar other location	General disorders	—	—
Chills	General disorders	—	—
Shivering	General disorders	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—
Sweating	General disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Swelling	General disorders	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—
Redness	General disorders	—	—
Rhinitis	Infections and infestations	—	—
Pyrexia	General disorders	—	—
Gastroenteritis	Infections and infestations	—	—
Influenza like illness	General disorders	—	—

Most-reported serious reactions: Asthma, Abortion spontaneous complete, Balance disorder, Benign prostatic hyperplasia, Breast cancer, Calculus ureteric, Nephrolithiasis, Renal disorder.

Data from ClinicalTrials.gov NCT00989287 adverse events section.

Sponsor's own description

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in adults aged 18 to 60 years.

Publications & conference data

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

Effect on cellular and humoral immune responses of the AS03 adjuvant system in an A/H1N1/2009 influenza virus vaccine administered to adults during two randomized controlled trials.
Roman F, Clément F, Dewé W, Walravens K, et al · · 2011 · cited 44× · PMID 21450978 · DOI 10.1128/cvi.00480-10
Safety of AS03-adjuvanted inactivated split virion A(H1N1)pdm09 and H5N1 influenza virus vaccines administered to adults: pooled analysis of 28 clinical trials.
Vaughn DW, Seifert H, Hepburn A, Dewe W, et al · · 2014 · cited 24× · PMID 25483467 · DOI 10.4161/21645515.2014.972149
Long-Term Persistence of Cell-Mediated and Humoral Responses to A(H1N1)pdm09 Influenza Virus Vaccines and the Role of the AS03 Adjuvant System in Adults during Two Randomized Controlled Trials.
van der Most RG, Clément F, Willekens J, Dewé W, et al · · 2017 · cited 17× · PMID 28446441 · DOI 10.1128/cvi.00553-16

Verify or expand the search:

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 NCT00989287 (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: 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/NCT00989287.

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

NCT00989287

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 (12 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Influenza

Other GlaxoSmithKline trials

Verify against primary sources