Who is sponsoring NCT01711736?

NCT01711736 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01711736?

Interventions in NCT01711736: Quadrivalent influenza GSK2282512A vaccine, Fluarix.

Is NCT01711736 still recruiting?

NCT01711736 is currently completed. Last updated 1 November 2021.

Are results published for NCT01711736?

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

Last reviewed 2021-11-01 · How we verify

NCT01711736

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

Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children 6 to 35 Months of Age

Completed Phase 3 Results posted Last updated 1 November 2021

What this trial tests

Phase 3 trial testing Quadrivalent influenza GSK2282512A vaccine in Influenza in 606 participants. Completed in 19 June 2013.

Timeline

1 November 2012

Primary endpoint
21 February 2013

19 June 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	606
Start date	1 November 2012
Primary completion	21 February 2013
Estimated completion	19 June 2013
Sites	8 locations across Canada, Dominican Republic, Honduras

Drugs / interventions tested

Quadrivalent influenza GSK2282512A vaccine — full drug profile →
Fluarix

Conditions studied

Influenza — all drugs for Influenza →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 6 Months to 35 Months, 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 Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Quadrivalent Influenza GSK2282512A Vaccine. Primary · At Day 28 for primed subjects and at Day 56 for unprimed subjects

A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 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 Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.

[H1N1, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	244

[H3N2, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	205

[Yamagata, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	224

[Victoria, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	210

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms. Primary · During the 7-day (Days 0-6) post-vaccination period

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. \>100mm.

Any Pain

Group	Value	95% CI
GSK2282512A Group	95
Fluarix Group	91

Grade 3 Pain

Group	Value	95% CI
GSK2282512A Group	7
Fluarix Group	3

Any Redness

Group	Value	95% CI
GSK2282512A Group	6
Fluarix Group	6

Grade 3 Redness

Group	Value	95% CI
GSK2282512A Group	0
Fluarix Group	0

Any Swelling

Group	Value	95% CI
GSK2282512A Group	5
Fluarix Group	6

Grade 3 Swelling

Group	Value	95% CI
GSK2282512A Group	0
Fluarix Group	0

Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms (Excluding Fever). Primary · During the 7-day (Days 0-6) post-vaccination period

Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.

Any Drowsiness

Group	Value	95% CI
GSK2282512A Group	93
Fluarix Group	88

Grade 3 Drowsiness

Group	Value	95% CI
GSK2282512A Group	9
Fluarix Group	9

Related Drowsiness

Group	Value	95% CI
GSK2282512A Group	79
Fluarix Group	80

Any Irritability/fussiness

Group	Value	95% CI
GSK2282512A Group	118
Fluarix Group	123

Grade 3 Irritability/fussiness

Group	Value	95% CI
GSK2282512A Group	15
Fluarix Group	14

Related Irritability/fussiness

Group	Value	95% CI
GSK2282512A Group	104
Fluarix Group	106

Any Loss of appetite

Group	Value	95% CI
GSK2282512A Group	99
Fluarix Group	100

Grade 3 Loss of appetite

Group	Value	95% CI
GSK2282512A Group	16
Fluarix Group	14

Number of Subjects Reporting Any, Grade 3 and Related Fever Primary · During the 7-day (Days 0-6) post-vaccination period

Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.

Any Fever

Group	Value	95% CI
GSK2282512A Group	61
Fluarix Group	60

Grade 3 Fever

Group	Value	95% CI
GSK2282512A Group	23
Fluarix Group	13

Related Fever

Group	Value	95% CI
GSK2282512A Group	49
Fluarix Group	48

Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Influenza Strains Secondary · At Day 0 (for all subjects) and 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)

HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)

[H1N1, Day 0]

Group	Value	95% CI
GSK2282512A Group	9.6	8.1 – 11.3
Fluarix Group	9.8	8.3 – 11.6

[H1N1, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	157.1	132.8 – 185.9
Fluarix Group	61.2	49.2 – 76.2

[H3N2, Day 0]

Group	Value	95% CI
GSK2282512A Group	17.4	14.1 – 21.5
Fluarix Group	13.8	11.4 – 16.8

[H3N2, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	159.4	129.4 – 196.3
Fluarix Group	103.0	83.7 – 126.7

[Yamagata, Day 0]

Group	Value	95% CI
GSK2282512A Group	7.7	6.9 – 8.7
Fluarix Group	7.2	6.5 – 8.0

[Yamagata, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	114.2	100.0 – 130.5
Fluarix Group	107.2	92.2 – 124.6

[Victoria, Day 0]

Group	Value	95% CI
GSK2282512A Group	10.6	9.1 – 12.4
Fluarix Group	9.3	8.0 – 10.7

[Victoria, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	111.4	91.9 – 135.2
Fluarix Group	15.6	13.3 – 18.5

Number of Seroconverted Subjects for Anti- Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains of Fluarix Vaccine Secondary · At Day 28 for primed subjects and at Day 56 for unprimed subjects

[H1N1, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
Fluarix Group	154

[H3N2, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
Fluarix Group	160

[Yamagata, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
Fluarix Group	222

[Victoria, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
Fluarix Group	28

Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against Each of the Four Vaccine Influenza Strains. Secondary · At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects)

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 in adults. The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)

[H1N1, Day 0]

Group	Value	95% CI
GSK2282512A Group	46
Fluarix Group	47

[H1N1, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	254
Fluarix Group	169

[H3N2, Day 0]

Group	Value	95% CI
GSK2282512A Group	93
Fluarix Group	74

[H3N2, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	231
Fluarix Group	191

[Yamagata, Day 0]

Group	Value	95% CI
GSK2282512A Group	26
Fluarix Group	24

[Yamagata, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	242
Fluarix Group	229

[Victoria, Day 0]

Group	Value	95% CI
GSK2282512A Group	56
Fluarix Group	45

[Victoria, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	216
Fluarix Group	74

Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Four Vaccine Influenza Strains. Secondary · 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects)

MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria)

[H1N1, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	16.4	14.3 – 18.7
Fluarix Group	6.2	5.3 – 7.3

[H3N2, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	9.1	8.0 – 10.5
Fluarix Group	7.5	6.4 – 8.7

[Yamagata, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	14.8	12.8 – 17.1
Fluarix Group	14.8	12.8 – 17.2

[Victoria, Day 28 = primed and Day 56 = unprimed]

Group	Value	95% CI
GSK2282512A Group	10.5	9.2 – 11.9
Fluarix Group	1.7	1.5 – 1.9

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

Any fever was defined as any fever ≥38.0 °C irrespective of intensity and relationship to vaccination. Related was defined as symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.

Any Fever

Group	Value	95% CI
GSK2282512A Group	46
Fluarix Group	42

Grade 3 Fever

Group	Value	95% CI
GSK2282512A Group	16
Fluarix Group	8

Related Fever

Group	Value	95% CI
GSK2282512A Group	39
Fluarix Group	38

Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs) Secondary · During the entire study period (Day 0 to Day 180)

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
GSK2282512A Group	156
Fluarix Group	156

Number of Subjects Reporting Any Potential Immune-Mediated Diseases (pIMDs) Secondary · During the entire study period (Day 0 to Day 180)

Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject.

Any pIMD(s)

Group	Value	95% CI
GSK2282512A Group	0
Fluarix Group	2

Related pIMD(s)

Group	Value	95% CI
GSK2282512A Group	0
Fluarix Group	0

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs). Secondary · During the 28-day (Days 0-27) post-vaccination period.

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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.

Any Unsolicited AEs

Group	Value	95% CI
GSK2282512A Group	142
Fluarix Group	165

Grade 3 Unsolicited AEs

Group	Value	95% CI
GSK2282512A Group	9
Fluarix Group	5

Related Unsolicited AEs

Group	Value	95% CI
GSK2282512A Group	17
Fluarix Group	13

Adverse events — posted to ClinicalTrials.gov

Time frame: Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) post-vaccination period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK2282512A Group

Serious: 9/299 (3%)

Deaths: —

Fluarix Group

Serious: 8/302 (3%)

Deaths: —

Serious adverse events (21 terms)

Reaction	System	GSK2282512A Group	Fluarix Group
Bronchiolitis	Infections and infestations	—	—
Gastroenteritis rotavirus	Infections and infestations	—	—
Dehydration	Metabolism and nutrition disorders	—	—
Amoebic dysentery	Infections and infestations	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Bacterial pyelonephritis	Infections and infestations	—	—
Blastocystis infection	Infections and infestations	—	—
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	—	—
Colitis ulcerative	Gastrointestinal disorders	—	—
Dengue fever	Infections and infestations	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Febrile convulsion	Nervous system disorders	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—
Otitis media acute	Infections and infestations	—	—
Peritonitis	Infections and infestations	—	—
Pharyngitis streptococcal	Infections and infestations	—	—
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	—	—
Respiratory syncytial virus bronchiolitis	Infections and infestations	—	—
Rotavirus infection	Infections and infestations	—	—
Septic shock	Infections and infestations	—	—
Tonsillitis	Infections and infestations	—	—

Other adverse events (8 terms — click to expand)

Reaction	System	GSK2282512A Group	Fluarix Group
Irritability/fussiness	General disorders	—	—
Loss of appetite	General disorders	—	—
Pain	General disorders	—	—
Drowsiness	General disorders	—	—
Nasopharyngitis	Infections and infestations	—	—
Fever	General disorders	—	—
Fever	General disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—

Most-reported serious reactions: Bronchiolitis, Gastroenteritis rotavirus, Dehydration, Amoebic dysentery, Asthma, Bacterial pyelonephritis, Blastocystis infection, Bronchial hyperreactivity.

Data from ClinicalTrials.gov NCT01711736 adverse events section.

Sponsor's own description

The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed vaccine Fluarix® (TIV) in young children 6 to 35 months of age.

Publications & conference data

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

Immunogenicity and safety of an inactivated quadrivalent influenza vaccine candidate: a phase III randomized controlled trial in children.
Langley JM, Carmona Martinez A, Chatterjee A, Halperin SA, et al · · 2013 · cited 56× · PMID 23847058 · DOI 10.1093/infdis/jit263
Immunogenicity and Reactogenicity of an Inactivated Quadrivalent Influenza Vaccine Administered Intramuscularly to Children 6 to 35 Months of Age in 2012-2013: A Randomized, Double-Blind, Controlled, Multicenter, Multicountry, Clinical Trial.
Langley JM, Wang L, Aggarwal N, Bueso A, et al · · 2015 · cited 27× · PMID 26336604 · DOI 10.1093/jpids/piu098
Immunogenicity and safety of quadrivalent inactivated influenza vaccine in children aged 6 to 35 months: A systematic review and meta-analysis.
Wei X, Tan X, Guan Q, Zhang R, et al · · 2023 · cited 2× · PMID 37794647 · DOI 10.1080/21645515.2023.2256510

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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 NCT01711736 (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: 1 November 2021

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/NCT01711736.

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

NCT01711736

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 (21 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Influenza

Other GlaxoSmithKline trials

Verify against primary sources