Last reviewed · How we verify

NCT00383123

Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children

Completed Phase 3 Results posted Last updated 8 June 2018
What this trial tests

Phase 3 trial testing Fluarix™ in Influenza in 3,327 participants. Completed in 19 October 2007.

Timeline
2 November 2006
Primary endpoint
1 October 2007
19 October 2007

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment3,327
Start date2 November 2006
Primary completion1 October 2007
Estimated completion19 October 2007
Sites40 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 6 Months to 17, 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.

Geometric Mean Titer (GMT) of Serum Haemagglutination-inhibition (HI) Antibodies Primary · 21 or 28 days after last vaccine dose

GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.

A/New Caledonia [6 to <36 months]
GroupValue95% CI
Fluarix Group52.443.3 – 63.4
Fluzone Group101.486.9 – 118.2
A/Wisconsin [6 to <36 months]
GroupValue95% CI
Fluarix Group80.562.2 – 104.1
Fluzone Group218.0185.8 – 255.8
B/Malaysia [6 to <36 months]
GroupValue95% CI
Fluarix Group20.215.9 – 25.8
Fluzone Group40.632.3 – 51.1
A/New Caledonia [3 to < 5 years]
GroupValue95% CI
Fluarix Group130.3108.6 – 156.4
Fluzone Group168.7138.7 – 205.2
A/Wisconsin [3 to < 5 years]
GroupValue95% CI
Fluarix Group458.1365.3 – 574.3
Fluzone Group483.4396.8 – 588.9
B/Malaysia [3 to < 5 years]
GroupValue95% CI
Fluarix Group54.942.3 – 71.1
Fluzone Group64.449.5 – 83.8
Number of Seroconverted Subjects Primary · 21 or 28 days after last vaccine dose

Seroconverted subjects are defined as subjects with either a pre-vaccination HI titer \<1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer. Data are presented for all 3 viral strains comprised in the vaccine.

A/New Caledonia [6 to <36 months]
GroupValue95% CI
Fluarix Group105
Fluzone Group179
A/Wisconsin [6 to <36 months]
GroupValue95% CI
Fluarix Group117
Fluzone Group190
B/Malaysia [6 to <36 months]
GroupValue95% CI
Fluarix Group48
Fluzone Group114
A/New Caledonia [3 to <5 years]
GroupValue95% CI
Fluarix Group160
Fluzone Group159
A/Wisconsin [3 to <5 years]
GroupValue95% CI
Fluarix Group156
Fluzone Group155
B/Malaysia [3 to <5 years]
GroupValue95% CI
Fluarix Group117
Fluzone Group122
Number of Subjects Reporting Rare Serious Events Primary · Up to 6 months after vaccination

Rare serious event is defined as any untoward medical event with an occurrence rate of ≥1/300 that: * resulted in death, * was life-threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, or * was a congenital anomaly/birth defect in the offspring of a study subject.

GroupValue95% CI
Fluarix Group11
Fluzone Group11
Number of Seroprotected Subjects Secondary · Before (PRE) and 21 or 28 days after (POST) the last vaccine dose

Seroprotected subjects are defined as vaccinees with a serum HI titer ≥ 1:40. Data are presented for all 3 viral strains comprised in the vaccine.

A/New Caledonia [6 to <36 months] PRE
GroupValue95% CI
Fluarix Group15
Fluzone Group16
A/New Caledonia [6 to <36 months] POST
GroupValue95% CI
Fluarix Group122
Fluzone Group193
A/Wisconsin [6 to <36 months] PRE
GroupValue95% CI
Fluarix Group39
Fluzone Group44
A/Wisconsin [6 to <36 months] POST
GroupValue95% CI
Fluarix Group135
Fluzone Group211
B/Malaysia [6 to <36 months] PRE
GroupValue95% CI
Fluarix Group11
Fluzone Group12
B/Malaysia [6 to <36 months] POST
GroupValue95% CI
Fluarix Group50
Fluzone Group115
A/New Caledonia [3 to <5 years] PRE
GroupValue95% CI
Fluarix Group38
Fluzone Group45
A/New Caledonia [3 to <5 years] POST
GroupValue95% CI
Fluarix Group180
Fluzone Group189
Number of Initially Unprotected Subjects With at Least a 4 Fold Increase in HI Titer Secondary · 21 or 28 days after last vaccine dose

Initially unprotected subjects are subjects with a baseline HI titer \< 1:40. Data are presented for all 3 viral strains comprised in the vaccine.

A/New Caledonia [6 to <36 months]
GroupValue95% CI
Fluarix Group125
Fluzone Group117
A/Wisconsin [6 to <36 months]
GroupValue95% CI
Fluarix Group114
Fluzone Group173
B/Malaysia [6 to <36 months]
GroupValue95% CI
Fluarix Group74
Fluzone Group129
A/New Caledonia [3 to <5 years]
GroupValue95% CI
Fluarix Group163
Fluzone Group155
A/Wisconsin [3 to <5 years]
GroupValue95% CI
Fluarix Group75
Fluzone Group92
B/Malaysia [3 to <5 years]
GroupValue95% CI
Fluarix Group115
Fluzone Group125
Number of Subjects Reporting Solicited Local and General Symptoms Secondary · During a 4-day follow-up period after each vaccination

Solicited local symptoms assessed include pain, redness, and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability, loss of appetite, arthralgia, fatigue, headache, muscle aches, and shivering. Data across doses are presented. Any = at least one symptom irrespective of intensity/relationship to vaccination; Grade 3: symptom that prevented normal everyday activities; Related: considered by the investigator as related to the study vaccination.

Pain [Any]
GroupValue95% CI
Fluarix Group1072
Fluzone Group526
Pain [Grade 3]
GroupValue95% CI
Fluarix Group31
Fluzone Group19
Redness [Any]
GroupValue95% CI
Fluarix Group421
Fluzone Group233
Redness [> 50 mm]
GroupValue95% CI
Fluarix Group16
Fluzone Group4
Swelling [Any]
GroupValue95% CI
Fluarix Group308
Fluzone Group152
Swelling [> 50 mm]
GroupValue95% CI
Fluarix Group22
Fluzone Group4
Drowsiness [Any]
GroupValue95% CI
Fluarix Group160
Fluzone Group177
Drowsiness [Grade 3]
GroupValue95% CI
Fluarix Group15
Fluzone Group16
Number of Subjects Reporting Unsolicited Adverse Events Secondary · Within 28 days following vaccination

An Adverse Event 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. Any = at least one symptom irrespective of intensity and relationship to vaccination; Grade 3 = preventing normal activity; Related = considered by the investigator to be causally related to the study vaccination.

Any
GroupValue95% CI
Fluarix Group700
Fluzone Group458
Grade 3
GroupValue95% CI
Fluarix Group102
Fluzone Group62
Related
GroupValue95% CI
Fluarix Group112
Fluzone Group75
Number of Subjects Reporting New Onset Chronic Illnesses and/or Serious Adverse Events (SAE) Secondary · Up to 6 months after vaccination

SAE: any untoward medical occurrence that * resulted in death, * was life-threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, or * was a congenital anomaly/birth defect in the offspring of a study subject. Examples of possible new onset chronic illnesses include but are not limited to diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders.

New onset chronic illnesses
GroupValue95% CI
Fluarix Group11
Fluzone Group3
Serious adverse events
GroupValue95% CI
Fluarix Group11
Fluzone Group11

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 4%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fluarix Group
Serious: 11
Deaths: 0
Fluzone Group
Serious: 11
Deaths: 0

Serious adverse events (22 terms)

ReactionSystemFluarix GroupFluzone Group
LymphadenitisBlood and lymphatic system disorders——
PneumoniaInfections and infestations——
Febrile convulsionNervous system disorders——
FaecalomaGastrointestinal disorders——
AppendicitisInfections and infestations——
CellulitisInfections and infestations——
GastroenteritisInfections and infestations——
Gastroenteritis viralInfections and infestations——
Infectious mononucleosisInfections and infestations——
Lobar pneumoniaInfections and infestations——
Meningitis enteroviralInfections and infestations——
Pharyngitis streptococcalInfections and infestations——
Pneumonia viralInfections and infestations——
Respiratory syncytial virus bronchiolitisInfections and infestations——
SalmonellosisInfections and infestations——
Traumatic brain injuryInjury, poisoning and procedural complications——
DehydrationMetabolism and nutrition disorders——
Abortion spontaneousPregnancy, puerperium and perinatal conditions——
Suicide attemptPsychiatric disorders——
AsthmaRespiratory, thoracic and mediastinal disorders——
PneumomediastinumRespiratory, thoracic and mediastinal disorders——
PneumothoraxRespiratory, thoracic and mediastinal disorders——
Other adverse events (14 terms — click to expand)

ReactionSystemFluarix GroupFluzone Group
Pain at the injection siteGeneral disorders——
Redness at the injection siteGeneral disorders——
Muscle achesGeneral disorders——
Swelling at the injection siteGeneral disorders——
FatigueGeneral disorders——
IrritabilityGeneral disorders——
HeadacheGeneral disorders——
DrowsinessGeneral disorders——
Axillary feverGeneral disorders——
Loss of appetiteGeneral disorders——
Upper respiratory tract infectionInfections and infestations——
PyrexiaGeneral disorders——
CoughRespiratory, thoracic and mediastinal disorders——
ArthralgiaGeneral disorders——

Most-reported serious reactions: Lymphadenitis, Pneumonia, Febrile convulsion, Faecaloma, Appendicitis, Cellulitis, Gastroenteritis, Gastroenteritis viral.

Data from ClinicalTrials.gov NCT00383123 adverse events section.

Sponsor's own description

The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Publications & conference data

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

  1. A Phase III evaluation of immunogenicity and safety of two trivalent inactivated seasonal influenza vaccines in US children.
    Baxter R, Jeanfreau R, Block SL, Blatter M, et al · · 2010 · cited 18× · PMID 20431425 · DOI 10.1097/inf.0b013e3181e075be
  2. Impact of Fever and Antipyretic Use on Influenza Vaccine Immune Reponses in Children.
    Li-Kim-Moy J, Wood N, Jones C, Macartney K, et al · · 2018 · cited 5× · PMID 29465480 · DOI 10.1097/inf.0000000000001949
  3. Statement on Seasonal Influenza Vaccine for 2012-2013: Appendix I: New Evidence Review for Children 24 to 59 Months of Age: An Advisory Committee Statement (ACS) National Advisory Committee on Immunization (NACI).
    · 2012 · cited 4× · PMID 31702744 · DOI 10.14745/ccdr.v38i00a02a

Verify or expand the search:

Other trials of Fluarix™

Trials testing the same drug.

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/NCT00383123.

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