Last reviewed · How we verify

NCT02242643

Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine (GSK2282512A) Compared to Fluzone® Quadrivalent in Children 6 to 35 Months of Age

Completed Phase 3 Results posted Last updated 7 September 2018
What this trial tests

Phase 3 trial testing FluLaval™ Quadrivalent in Influenza in 2,432 participants. Completed in 23 June 2015.

Timeline
1 October 2014
Primary endpoint
16 March 2015
23 June 2015

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment2,432
Start date1 October 2014
Primary completion16 March 2015
Estimated completion23 June 2015
Sites66 locations across United States, Mexico

Drugs / interventions tested

Conditions studied

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.

Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains Primary · 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)

Antibody titers were expressed as Seroconversion rate (SCR) and SCR difference. SCR was defined as the proportion of vaccinees 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 vaccine strains assessed were Flu A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).

H1N1 [N=972,980]
GroupValue95% CI
FluLaval™ Quadrivalent Group716
Fluzone® Quadrivalent Group660
H3N2 [N=972,980]
GroupValue95% CI
FluLaval™ Quadrivalent Group740
Fluzone® Quadrivalent Group680
Victoria [N=973,980]
GroupValue95% CI
FluLaval™ Quadrivalent Group631
Fluzone® Quadrivalent Group475
Yamagata [N=974,980]
GroupValue95% CI
FluLaval™ Quadrivalent Group833
Fluzone® Quadrivalent Group723
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies by Calculating Serum Antihaemagglutination (HA) Antibody Titers Against the 4 Vaccine Strains. Primary · At 28 days after the last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)

HI antibody titres were expressed as geometric mean titers (GMTs) and adjusted GMT ratios. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).

H1N1
GroupValue95% CI
FluLaval™ Quadrivalent Group98.890.3 – 108.2
Fluzone® Quadrivalent Group84.476.9 – 92.6
H3N2
GroupValue95% CI
FluLaval™ Quadrivalent Group97.790.3 – 105.7
Fluzone® Quadrivalent Group84.377.6 – 91.6
Yamagata
GroupValue95% CI
FluLaval™ Quadrivalent Group257.5240.9 – 275.3
Fluzone® Quadrivalent Group164.2151.8 – 177.6
Victoria
GroupValue95% CI
FluLaval™ Quadrivalent Group55.150.8 – 59.8
Fluzone® Quadrivalent Group33.430.6 – 36.4
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) Secondary · At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)

Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were A/California/7/2009 (H1N1), A/Texas/50/2012 (H3N2), B/Massachusetts/2/2012 (Yamagata) and B/Brisbane/60/2008 (Victoria).

H1N1, Day 0
GroupValue95% CI
FluLaval™ Quadrivalent Group11.010.2 – 12.0
Fluzone® Quadrivalent Group11.110.2 – 12.0
H1N1, Day 28/Day 56
GroupValue95% CI
FluLaval™ Quadrivalent Group98.890.3 – 108.2
Fluzone® Quadrivalent Group84.476.9 – 92.6
H3N2, Day 0
GroupValue95% CI
FluLaval™ Quadrivalent Group9.28.6 – 9.8
Fluzone® Quadrivalent Group9.68.9 – 10.3
H3N2, Day 28/Day 56
GroupValue95% CI
FluLaval™ Quadrivalent Group97.790.3 – 105.7
Fluzone® Quadrivalent Group84.377.6 – 91.6
Yamagata, Day 0
GroupValue95% CI
FluLaval™ Quadrivalent Group20.318.8 – 22.0
Fluzone® Quadrivalent Group20.619.0 – 22.4
Yamagata, Day 28/Day 56
GroupValue95% CI
FluLaval™ Quadrivalent Group257.5240.9 – 275.3
Fluzone® Quadrivalent Group164.2151.8 – 177.6
Victoria, Day 0
GroupValue95% CI
FluLaval™ Quadrivalent Group6.26.0 – 6.5
Fluzone® Quadrivalent Group6.36.0 – 6.6
Victoria, Day 28/Day 56
GroupValue95% CI
FluLaval™ Quadrivalent Group55.150.8 – 59.8
Fluzone® Quadrivalent Group33.430.6 – 36.4
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) Secondary · At Day 0 and 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)

A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40. The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).

H1N1, Day 0
GroupValue95% CI
FluLaval™ Quadrivalent Group191
Fluzone® Quadrivalent Group190
H1N1, Day 28/56
GroupValue95% CI
FluLaval™ Quadrivalent Group814
Fluzone® Quadrivalent Group775
H3N2, Day 0
GroupValue95% CI
FluLaval™ Quadrivalent Group135
Fluzone® Quadrivalent Group140
H3N2, Day 28/56
GroupValue95% CI
FluLaval™ Quadrivalent Group833
Fluzone® Quadrivalent Group800
Yamagata, Day 0
GroupValue95% CI
FluLaval™ Quadrivalent Group324
Fluzone® Quadrivalent Group336
Yamagata, Day 28/56
GroupValue95% CI
FluLaval™ Quadrivalent Group983
Fluzone® Quadrivalent Group911
Victoria, Day 0
GroupValue95% CI
FluLaval™ Quadrivalent Group40
Fluzone® Quadrivalent Group46
Victoria, Day 28/56
GroupValue95% CI
FluLaval™ Quadrivalent Group669
Fluzone® Quadrivalent Group512
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) Secondary · 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-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 ≥ 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/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).

H1N1 [N=972,980]
GroupValue95% CI
FluLaval™ Quadrivalent Group716
Fluzone® Quadrivalent Group660
H3N2 [N=972,980]
GroupValue95% CI
FluLaval™ Quadrivalent Group740
Fluzone® Quadrivalent Group680
Yamagata [N=974,980]
GroupValue95% CI
FluLaval™ Quadrivalent Group833
Fluzone® Quadrivalent Group723
Victoria [N=973,980]
GroupValue95% CI
FluLaval™ Quadrivalent Group631
Fluzone® Quadrivalent Group475
H1N1, 6-17M [N=376,375]
GroupValue95% CI
FluLaval™ Quadrivalent Group220
Fluzone® Quadrivalent Group216
H1N1, 18-35M [N=596,605]
GroupValue95% CI
FluLaval™ Quadrivalent Group496
Fluzone® Quadrivalent Group444
H3N2, 6-17M [N=376,375]
GroupValue95% CI
FluLaval™ Quadrivalent Group260
Fluzone® Quadrivalent Group250
H3N2, 18-35M [N=596,605]
GroupValue95% CI
FluLaval™ Quadrivalent Group480
Fluzone® Quadrivalent Group430
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the 4 Vaccine Influenza Strains, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) Secondary · 28 days after last vaccine dose (i.e. Day 28 for vaccine-primed subjects and Day 56 for vaccine-unprimed subjects)

MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/California/7/2009 (H1N1) HI, A/Texas/50/2012 (H3N2) HI, B/Massachusetts/2/2012 (Yamagata) HI and B/Brisbane/60/2008 (Victoria).

H1N1 [N=972,980]
GroupValue95% CI
FluLaval™ Quadrivalent Group9.08.4 – 9.7
Fluzone® Quadrivalent Group7.77.1 – 8.3
H3N2 [N=972,980]
GroupValue95% CI
FluLaval™ Quadrivalent Group10.710.0 – 11.6
Fluzone® Quadrivalent Group8.98.2 – 9.7
Yamagata [N=974,980]
GroupValue95% CI
FluLaval™ Quadrivalent Group12.711.7 – 13.7
Fluzone® Quadrivalent Group8.17.5 – 8.8
Victoria [N=973,980]
GroupValue95% CI
FluLaval™ Quadrivalent Group8.78.1 – 9.4
Fluzone® Quadrivalent Group5.45.0 – 5.8
H1N1, 6-17M [N=376,375]
GroupValue95% CI
FluLaval™ Quadrivalent Group6.05.3 – 6.8
Fluzone® Quadrivalent Group6.15.2 – 7.1
H1N1, 18-35M [N=596,605]
GroupValue95% CI
FluLaval™ Quadrivalent Group11.710.7 – 12.8
Fluzone® Quadrivalent Group8.98.1 – 9.8
H3N2, 6-17M [N=376,375]
GroupValue95% CI
FluLaval™ Quadrivalent Group10.29.0 – 11.6
Fluzone® Quadrivalent Group8.87.7 – 10.2
H3N2, 18-35M [N=596,605]
GroupValue95% CI
FluLaval™ Quadrivalent Group11.110.1 – 12.1
Fluzone® Quadrivalent Group9.08.2 – 9.9
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) Secondary · During a 7-day (Day 0 - Day 6) follow-up period after each vaccination

Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity and all subjects reporting 'Yes' for solicited symptom occurred but with missing values for at least one day during the solicited period. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness and swelling was greater than 100 millimeters (mm) i.e. \>100mm.

Any Pain, Dose 1 [N=1151,1146]
GroupValue95% CI
FluLaval™ Quadrivalent Group464
Fluzone® Quadrivalent Group429
Grade 3 Pain, Dose 1 [N=1151,1146]
GroupValue95% CI
FluLaval™ Quadrivalent Group28
Fluzone® Quadrivalent Group16
Any Redness, Dose 1 [N=1151,1146]
GroupValue95% CI
FluLaval™ Quadrivalent Group15
Fluzone® Quadrivalent Group15
Grade 3 Redness, Dose 1 [N=1151,1146]
GroupValue95% CI
FluLaval™ Quadrivalent Group0
Fluzone® Quadrivalent Group0
Any Swelling, Dose 1 [N=1151,1146]
GroupValue95% CI
FluLaval™ Quadrivalent Group11
Fluzone® Quadrivalent Group5
Grade 3 Swelling, Dose 1 [N=1151,1146]
GroupValue95% CI
FluLaval™ Quadrivalent Group0
Fluzone® Quadrivalent Group0
Any Pain, Dose 2 [N=490,493]
GroupValue95% CI
FluLaval™ Quadrivalent Group138
Fluzone® Quadrivalent Group147
Grade 3 Pain, Dose 2 [N=490,493]
GroupValue95% CI
FluLaval™ Quadrivalent Group9
Fluzone® Quadrivalent Group3
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) Secondary · During the 7-day (Days 0-6) follow-up period after each vaccination

Solicited general symptoms assessed were drowsiness, irritability/fussiness, loss of appetite and fever. 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 fever was defined as su

Any Drowsiness, Dose 1 [N=1155,1148]
GroupValue95% CI
FluLaval™ Quadrivalent Group424
Fluzone® Quadrivalent Group424
Grade 3 Drowsiness, Dose 1 [N=1155,1148]
GroupValue95% CI
FluLaval™ Quadrivalent Group31
Fluzone® Quadrivalent Group30
Related Drowsiness, Dose 1 [N=1155,1148]
GroupValue95% CI
FluLaval™ Quadrivalent Group365
Fluzone® Quadrivalent Group381
Any Fever, Dose 1 [N=1155,1148]
GroupValue95% CI
FluLaval™ Quadrivalent Group146
Fluzone® Quadrivalent Group147
Fever (≥38.0°C), Dose 1 [N=1155,1148]
GroupValue95% CI
FluLaval™ Quadrivalent Group65
Fluzone® Quadrivalent Group67
Grade 3 Fever, Dose 1 [N=1155,1148]
GroupValue95% CI
FluLaval™ Quadrivalent Group16
Fluzone® Quadrivalent Group11
Related Fever, Dose 1 [N=1155,1148]
GroupValue95% CI
FluLaval™ Quadrivalent Group41
Fluzone® Quadrivalent Group50
≥38.0°C Related Fever, Dose 1 [N=1155,1148]
GroupValue95% CI
FluLaval™ Quadrivalent Group41
Fluzone® Quadrivalent Group50
Duration of Solicited Local and General AEs, Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) Secondary · During the 7-day (Days 0-6) follow-up period after each vaccination.

Duration was defined as number of days with any grade of local and general symptoms.

Drowsiness, Dose 1 [N=424,424]
GroupValue95% CI
FluLaval™ Quadrivalent Group1.01.0 – 7.0
Fluzone® Quadrivalent Group1.51.0 – 7.0
Drowsiness, Dose 2 [N=157,166]
GroupValue95% CI
FluLaval™ Quadrivalent Group2.01.0 – 7.0
Fluzone® Quadrivalent Group2.01.0 – 7.0
Irritability, Dose 1 [N=570, 527]
GroupValue95% CI
FluLaval™ Quadrivalent Group2.01.0 – 7.0
Fluzone® Quadrivalent Group2.01.0 – 7.0
Irritability, Dose 2 [N=211,214]
GroupValue95% CI
FluLaval™ Quadrivalent Group2.01.0 – 7.0
Fluzone® Quadrivalent Group2.01.0 – 7.0
Loss of Appetite, Dose 1 [N=334, 328]
GroupValue95% CI
FluLaval™ Quadrivalent Group2.01.0 – 7.0
Fluzone® Quadrivalent Group2.01.0 – 7.0
Loss of Appetite, Dose 2 [N=110,116]
GroupValue95% CI
FluLaval™ Quadrivalent Group2.01.0 – 7.0
Fluzone® Quadrivalent Group2.01.0 – 7.0
Pain, Dose 1 [N=464,429]
GroupValue95% CI
FluLaval™ Quadrivalent Group1.01.0 – 7.0
Fluzone® Quadrivalent Group2.01.0 – 6.0
Pain, Dose 2 [N=138,147]
GroupValue95% CI
FluLaval™ Quadrivalent Group1.01.0 – 6.0
Fluzone® Quadrivalent Group1.01.0 – 5.0
Number of Subjects Reporting Any Fever Following Each Dose and Across Doses. Secondary · During a 2-day (Days 0-1) follow-up period after each vaccination

Any Fever = all subjects with a documented temperature of ≥38.0°C /100.4°F by axillary route and all subjects reporting temperature \< 38.0°C but with missing values for at least one day during the solicited period. Grade 3 fever was defined as temperature greater than (\>) 39.0°C.

Any Fever, Dose 1 [N=1155,1148]
GroupValue95% CI
FluLaval™ Quadrivalent Group63
Fluzone® Quadrivalent Group74
Fever (≥38.0°C), Dose 1 [N=1155,1148]
GroupValue95% CI
FluLaval™ Quadrivalent Group30
Fluzone® Quadrivalent Group34
Grade 3 Fever (>39.0°C), Dose 1 [N=1155,1148]
GroupValue95% CI
FluLaval™ Quadrivalent Group6
Fluzone® Quadrivalent Group4
Any Fever, Dose 2 [N=490,495]
GroupValue95% CI
FluLaval™ Quadrivalent Group21
Fluzone® Quadrivalent Group22
Fever (≥38.0°C), Dose 2 [N=490,495]
GroupValue95% CI
FluLaval™ Quadrivalent Group12
Fluzone® Quadrivalent Group10
Grade 3 Fever (>39.0°C), Dose 2 [N=490,495]
GroupValue95% CI
FluLaval™ Quadrivalent Group3
Fluzone® Quadrivalent Group2
Any Fever, Across Doses [N=1159,1152]
GroupValue95% CI
FluLaval™ Quadrivalent Group82
Fluzone® Quadrivalent Group93
Fever (≥38.0°C), Across Doses [N=1159,1152]
GroupValue95% CI
FluLaval™ Quadrivalent Group42
Fluzone® Quadrivalent Group43
Number of Subjects Reporting the Occurrence of All Medically Attended Events (MAEs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed). Secondary · During the entire study period (Days 0 -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).

Any MAE(s) [N=1207,1217]
GroupValue95% CI
FluLaval™ Quadrivalent Group727
Fluzone® Quadrivalent Group719
Any MAE(s), 6-17M [N=500,502]
GroupValue95% CI
FluLaval™ Quadrivalent Group322
Fluzone® Quadrivalent Group323
Any MAE(s), 18-35M [N=707,715]
GroupValue95% CI
FluLaval™ Quadrivalent Group405
Fluzone® Quadrivalent Group396
Any MAE(s), Unprimed [N=550,560]
GroupValue95% CI
FluLaval™ Quadrivalent Group344
Fluzone® Quadrivalent Group337
Any MAE(s), Primed [N=657,657]
GroupValue95% CI
FluLaval™ Quadrivalent Group383
Fluzone® Quadrivalent Group382
Number of Subjects Reporting the Occurrence of Any and Related Potential Immune-Mediated Disease (pIMDs), Overall, by Age Group (6-17 and 18-35 Months of Age) and by Priming Status (Vaccine-primed and Vaccine-unprimed) Secondary · During the entire study period (Days 0 -180)

pIMDs are a subset of adverse events (AEs) that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Related = symptom assed by the investigator as causally related to the study vaccination.

Any pIMD(s) [N=1207,1217]
GroupValue95% CI
FluLaval™ Quadrivalent Group1
Fluzone® Quadrivalent Group1
Related pIMD(s) [N=1207,1217]
GroupValue95% CI
FluLaval™ Quadrivalent Group0
Fluzone® Quadrivalent Group0
Any pIMD(s), 6-17M [N=500,502]
GroupValue95% CI
FluLaval™ Quadrivalent Group1
Fluzone® Quadrivalent Group1
Related pIMD(s), 6-17M [N=500,502]
GroupValue95% CI
FluLaval™ Quadrivalent Group0
Fluzone® Quadrivalent Group0
Any pIMD(s), 18-35M [N=707,715]
GroupValue95% CI
FluLaval™ Quadrivalent Group0
Fluzone® Quadrivalent Group0
Related pIMD(s), 18-35M [N=707,715]
GroupValue95% CI
FluLaval™ Quadrivalent Group0
Fluzone® Quadrivalent Group0
Any pIMD(s), Unprimed [N=550,560]
GroupValue95% CI
FluLaval™ Quadrivalent Group0
Fluzone® Quadrivalent Group0
Related pIMD(s), Unprimed [N=550,560]
GroupValue95% CI
FluLaval™ Quadrivalent Group0
Fluzone® Quadrivalent Group0

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 across doses; Unsolicited adverse events: During the 28-day post-vaccination period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FluLaval™ Quadrivalent Group
Serious: 5/1207 (0%)
Deaths: —
Fluzone® Quadrivalent Group
Serious: 4/1217 (0%)
Deaths: —

Serious adverse events (35 terms)

ReactionSystemFluLaval™ Quadrivalent GroupFluzone® Quadrivalent Group
Febrile convulsionNervous system disorders——
DehydrationMetabolism and nutrition disorders——
AsthmaRespiratory, thoracic and mediastinal disorders——
BronchiolitisInfections and infestations——
GastroenteritisInfections and infestations——
Respiratory syncytial virus bronchiolitisInfections and infestations——
CellulitisInfections and infestations——
Urinary tract infectionInfections and infestations——
AbscessInfections and infestations——
Accidental exposure to productInjury, poisoning and procedural complications——
B precursor type acute leukaemiaNeoplasms benign, malignant and unspecified (incl cysts and polyps)——
Calculus urinaryRenal and urinary disorders——
ConcussionInjury, poisoning and procedural complications——
ConstipationGastrointestinal disorders——
Craniocerebral injuryInjury, poisoning and procedural complications——
Croup infectiousInfections and infestations——
Developmental delayGeneral disorders——
Failure to thriveMetabolism and nutrition disorders——
Gastroenteritis rotavirusInfections and infestations——
Groin abscessInfections and infestations——
HemiplegiaNervous system disorders——
HyponatraemiaMetabolism and nutrition disorders——
HypoxiaRespiratory, thoracic and mediastinal disorders——
IntussusceptionGastrointestinal disorders——
Kawasaki's diseaseVascular disorders——
Other adverse events (12 terms — click to expand)

ReactionSystemFluLaval™ Quadrivalent GroupFluzone® Quadrivalent Group
Irritability/FussinessGeneral disorders——
PainGeneral disorders——
DrowsinessGeneral disorders——
Loss of AppetiteGeneral disorders——
FeverGeneral disorders——
Upper respiratory tract infectionInfections and infestations——
FeverGeneral disorders——
CoughRespiratory, thoracic and mediastinal disorders——
RhinorrhoeaRespiratory, thoracic and mediastinal disorders——
NasopharyngitisInfections and infestations——
DiarrhoeaGastrointestinal disorders——
Otitis mediaInfections and infestations——

Most-reported serious reactions: Febrile convulsion, Dehydration, Asthma, Bronchiolitis, Gastroenteritis, Respiratory syncytial virus bronchiolitis, Cellulitis, Urinary tract infection.

Data from ClinicalTrials.gov NCT02242643 adverse events section.

Sponsor's own description

The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' quadrivalent influenza vaccine (GSK2282512A) compared to Sanofi Pasteur's Fluzone® Quadrivalent in children 6 to 35 months of age.

Publications & conference data

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

  1. Time to Change Dosing of Inactivated Quadrivalent Influenza Vaccine in Young Children: Evidence From a Phase III, Randomized, Controlled Trial.
    Jain VK, Domachowske JB, Wang L, Ofori-Anyinam O, et al · · 2017 · cited 26× · PMID 28062552 · DOI 10.1093/jpids/piw068
  2. Immunogenicity and Safety of an Inactivated Quadrivalent Influenza Vaccine in US Children 6-35 Months of Age During 2013-2014: Results From A Phase II Randomized Trial.
    Wang L, Chandrasekaran V, Domachowske JB, Li P, et al · · 2016 · cited 23× · PMID 26407273 · DOI 10.1093/jpids/piv041
  3. 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

Verify or expand the search:

Other recruiting trials for Influenza

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT02242643.

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