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NCT00321373

Study to Evaluate an Influenza Vaccine Candidate

Completed Phase 2 Results posted Last updated 8 June 2018
What this trial tests

Phase 2 trial testing Candidate Influenza Vaccine GSK1247446A - 2 different formulations in Influenza in 1,220 participants. Completed in 18 July 2006.

Timeline
11 May 2006
Primary endpoint
1 July 2006
18 July 2006

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment1,220
Start date11 May 2006
Primary completion1 July 2006
Estimated completion18 July 2006
Sites17 locations across Finland, Greece

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

60 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.

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus Primary · At Days 0 and 21 post-vaccination

Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.

A/New Caledonia, Day 0 [N=395,393,389]
GroupValue95% CI
GSK1247446A-AS03 Group13.412.3 – 14.8
GSK1247446A Group13.912.6 – 15.3
Fluarix Group14.213.0 – 15.6
A/New York, Day 0 [N=395,393,389]
GroupValue95% CI
GSK1247446A-AS03 Group10.89.9 – 11.8
GSK1247446A Group11.910.7 – 13.1
Fluarix Group11.510.5 – 12.7
B/Malaysia, Day 0 [N=395,393,389]
GroupValue95% CI
GSK1247446A-AS03 Group17.816.0 – 19.7
GSK1247446A Group16.014.4 – 17.8
Fluarix Group15.614.0 – 17.4
A/New Caledonia, Day 21 [N=395,393,389]
GroupValue95% CI
GSK1247446A-AS03 Group168.0148.5 – 190.1
GSK1247446A Group97.785.7 – 111.3
Fluarix Group202.4177.4 – 230.9
A/New York, Day 21 [N=395,393,389]
GroupValue95% CI
GSK1247446A-AS03 Group179.8159.3 – 202.9
GSK1247446A Group70.461.3 – 80.7
Fluarix Group104.391.5 – 118.9
B/Malaysia, Day 21 [N=394,390,389]
GroupValue95% CI
GSK1247446A-AS03 Group341.2305.7 – 380.9
GSK1247446A Group175.4154.1 – 199.5
Fluarix Group292.0257.1 – 331.5
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Virus Secondary · At Day 180 post-vaccination.

Titers are presented as geometric mean titers (GMTs). The 3 flu strains assessed were A/New Caledonia, A/New York and B/Malaysia. The reference seropositivity cut-off value was ≥ 1:10.

A/New Caledonia at Day180
GroupValue95% CI
GSK1247446A-AS03 Group64.357.6 – 71.8
GSK1247446A Group54.348.3 – 61.0
Fluarix Group84.474.8 – 95.3
A/New York at Day180
GroupValue95% CI
GSK1247446A-AS03 Group56.850.9 – 63.5
GSK1247446A Group35.831.7 – 40.3
Fluarix Group42.437.7 – 47.6
B/Malaysia at Day180
GroupValue95% CI
GSK1247446A-AS03 Group88.679.0 – 99.3
GSK1247446A Group65.258.0 – 73.3
Fluarix Group90.980.7 – 102.5
Number of Subjects With Any and Grade 3 Solicited Local Symptoms. Secondary · During the 7-day (Days 0-6) follow-up period after vaccination

Assessed solicited local symptoms were ecchymosis, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling spreading beyond 50 millimeters (mm) of injection site.

Any Pain
GroupValue95% CI
GSK1247446A-AS03 Group246
GSK1247446A Group32
Fluarix Group86
Grade 3 Pain
GroupValue95% CI
GSK1247446A-AS03 Group12
GSK1247446A Group0
Fluarix Group1
Any Ecchymosis
GroupValue95% CI
GSK1247446A-AS03 Group28
GSK1247446A Group20
Fluarix Group19
Ecchymosis > 50mm
GroupValue95% CI
GSK1247446A-AS03 Group1
GSK1247446A Group0
Fluarix Group1
Any Redness
GroupValue95% CI
GSK1247446A-AS03 Group95
GSK1247446A Group50
Fluarix Group65
Redness > 50mm
GroupValue95% CI
GSK1247446A-AS03 Group22
GSK1247446A Group1
Fluarix Group6
Any Swelling
GroupValue95% CI
GSK1247446A-AS03 Group84
GSK1247446A Group8
Fluarix Group50
Swelling > 50mm
GroupValue95% CI
GSK1247446A-AS03 Group19
GSK1247446A Group0
Fluarix Group4
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. Secondary · During the 7-day (Days 0-6) follow up period after vaccination

Assessed solicited general symptoms were arthralgia, fatigue, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\], headache, muscle aches, shivering. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.

Any Arthralgia
GroupValue95% CI
GSK1247446A-AS03 Group80
GSK1247446A Group17
Fluarix Group21
Grade 3 Arthralgia
GroupValue95% CI
GSK1247446A-AS03 Group6
GSK1247446A Group0
Fluarix Group1
Related Arthralgia
GroupValue95% CI
GSK1247446A-AS03 Group73
GSK1247446A Group14
Fluarix Group18
Any Fatigue
GroupValue95% CI
GSK1247446A-AS03 Group149
GSK1247446A Group42
Fluarix Group47
Grade 3 Fatigue
GroupValue95% CI
GSK1247446A-AS03 Group6
GSK1247446A Group1
Fluarix Group0
Related Fatigue
GroupValue95% CI
GSK1247446A-AS03 Group148
GSK1247446A Group36
Fluarix Group42
Fever (oral) ≥37.5°C
GroupValue95% CI
GSK1247446A-AS03 Group21
GSK1247446A Group4
Fluarix Group2
Fever (oral) ≥39.0°C
GroupValue95% CI
GSK1247446A-AS03 Group0
GSK1247446A Group0
Fluarix Group0
Number of Subjects With Unsolicited Adverse Events (AEs). Secondary · During the 30-day (Days 0-29) follow-up period after vaccination

An unsolicited AE covers 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 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investiga

Subjects with any AEs
GroupValue95% CI
GSK1247446A-AS03 Group114
GSK1247446A Group82
Fluarix Group95
Subjects with Grade 3 AEs
GroupValue95% CI
GSK1247446A-AS03 Group13
GSK1247446A Group11
Fluarix Group16
Subjects with related AEs
GroupValue95% CI
GSK1247446A-AS03 Group43
GSK1247446A Group19
Fluarix Group19
Number of Subjects With Any and Related Serious Adverse Events (SAEs) Secondary · During the entire study period (Day 0 to Day 180)

SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = occurrence of any SAE regardless of intensity grade or relation to vaccination. Related = SAE assessed by the investigator as related to the vaccination.

Subjects with any SAE(s)
GroupValue95% CI
GSK1247446A-AS03 Group8
GSK1247446A Group13
Fluarix Group13
Subjects with related SAE(s)
GroupValue95% CI
GSK1247446A-AS03 Group2
GSK1247446A Group1
Fluarix Group0

Adverse events — posted to ClinicalTrials.gov

Time frame: SAEs were collected during the entire study (Days 0-180). AEs were collected during the 30-day (Days 0-29) post-vaccination period. Solicited local/general symptoms were collected during the 7-day (Days 0-6) post-vaccination period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK1247446A-AS03 Group
Serious: 8/407 (2%)
Deaths: —
GSK1247446A Group
Serious: 13/406 (3%)
Deaths: —
Fluarix Group
Serious: 13/407 (3%)
Deaths: —

Serious adverse events (37 terms)

ReactionSystemGSK1247446A-AS03 GroupGSK1247446A GroupFluarix Group
Cerebral infarctionNervous system disorders———
Abdominal painGastrointestinal disorders———
Gastric ulcerGastrointestinal disorders———
Gastrointestinal haemorrhageGastrointestinal disorders———
Gastrooesophageal reflux diseaseGastrointestinal disorders———
Grand mal convulsionNervous system disorders———
Injection site erythemaGeneral disorders———
Pancreatic neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)———
Pulmonary embolismRespiratory, thoracic and mediastinal disorders———
PyrexiaGeneral disorders———
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)———
CholecystitisHepatobiliary disorders———
ArthralgiaMusculoskeletal and connective tissue disorders———
AsthmaRespiratory, thoracic and mediastinal disorders———
Brain stem thrombosisNervous system disorders———
Cardiac failureCardiac disorders———
CholelithiasisHepatobiliary disorders———
ConcussionInjury, poisoning and procedural complications———
Dermatitis allergicSkin and subcutaneous tissue disorders———
DiverticulitisInfections and infestations———
DrowningGeneral disorders———
ExtrasystolesCardiac disorders———
Femoral neck fractureInjury, poisoning and procedural complications———
Gastric ulcerGastrointestinal disorders———
Irritable bowel syndromeGastrointestinal disorders———
Other adverse events (10 terms — click to expand)

ReactionSystemGSK1247446A-AS03 GroupGSK1247446A GroupFluarix Group
PainGeneral disorders———
FatigueGeneral disorders———
Muscle achesGeneral disorders———
HeadacheGeneral disorders———
ShiveringGeneral disorders———
RednessGeneral disorders———
SwellingGeneral disorders———
ArthralgiaGeneral disorders———
EcchymosisGeneral disorders———
FeverGeneral disorders———

Most-reported serious reactions: Cerebral infarction, Abdominal pain, Gastric ulcer, Gastrointestinal haemorrhage, Gastrooesophageal reflux disease, Grand mal convulsion, Injection site erythema, Pancreatic neoplasm.

Data from ClinicalTrials.gov NCT00321373 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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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/NCT00321373.

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