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NCT00992511

Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes

Completed Phase 3 Results posted Last updated 31 January 2019
What this trial tests

Phase 3 trial testing GSK investigational vaccine GSK2340272A in Influenza in 300 participants. Completed in 9 November 2010.

Timeline
14 October 2009
Primary endpoint
9 November 2010
9 November 2010

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposeprevention
Enrollment300
Start date14 October 2009
Primary completion9 November 2010
Estimated completion9 November 2010
Sites4 locations across Germany

Drugs / interventions tested

Conditions studied

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 Subjects Who Were Seroprotected for Haemagglutination Inhibition (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 (≥) 1:10, that usually is accepted as indicating protection.

GroupValue95% CI
GSK2340272A New 1D Group74
GSK2340272A New 2D Group64
GSK2340272A INI 1D Group69
GSK2340272A INI 2D Group63
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 2 Strains of Influenza Disease Primary · At Day 21

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.

GroupValue95% CI
GSK2340272A New 1D Group323.0253.4 – 411.8
GSK2340272A New 2D Group334.2267.9 – 416.9
GSK2340272A INI 1D Group341.5261.7 – 445.6
GSK2340272A INI 2D Group398.9294.8 – 539.7
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Secondary · At Days 0 and 42

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.

Flu A/CAL/7/09, Day 0
GroupValue95% CI
GSK2340272A New 1D Group28
GSK2340272A New 2D Group23
GSK2340272A INI 1D Group30
GSK2340272A INI 2D Group22
Flu A/CAL/7/09, Day 42
GroupValue95% CI
GSK2340272A New 1D Group74
GSK2340272A New 2D Group64
GSK2340272A INI 1D Group71
GSK2340272A INI 2D Group62
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Secondary · At Days 0 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
GroupValue95% CI
GSK2340272A New 1D Group8.67.0 – 10.6
GSK2340272A New 2D Group8.06.7 – 9.6
GSK2340272A INI 1D Group8.97.2 – 11.0
GSK2340272A INI 2D Group8.46.8 – 10.3
Flu A/CAL/7/09, Day 42
GroupValue95% CI
GSK2340272A New 1D Group226.4176.8 – 289.8
GSK2340272A New 2D Group470.0387.9 – 569.6
GSK2340272A INI 1D Group268.4206.2 – 349.3
GSK2340272A INI 2D Group676.8564.7 – 811.3
Number of Subjects Who Were Seroprotected for Haemagglutination Inhibition (HI) Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Secondary · At Days 182 and 364

A seroprotected 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/California/7/2009, Day 182
GroupValue95% CI
GSK2340272A New 1D Group71
GSK2340272A New 2D Group68
GSK2340272A INI 1D Group68
GSK2340272A INI 2D Group65
Flu A/California/7/2009, Day 364
GroupValue95% CI
GSK2340272A New 1D Group64
GSK2340272A New 2D Group63
GSK2340272A INI 1D Group60
GSK2340272A INI 2D Group58
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against Flu A/California/7/2009 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/California/7/2009, Day 182
GroupValue95% CI
GSK2340272A New 1D Group102.779.4 – 132.9
GSK2340272A New 2D Group147.5120.9 – 180.0
GSK2340272A INI 1D Group128.394.9 – 173.3
GSK2340272A INI 2D Group226.3183.5 – 279.1
Flu A/California/7/2009, Day 364
GroupValue95% CI
GSK2340272A New 1D Group63.948.8 – 83.7
GSK2340272A New 2D Group75.759.8 – 96.0
GSK2340272A INI 1D Group81.358.6 – 112.7
GSK2340272A INI 2D Group123.795.2 – 160.8
Number of Seroconverted (SCR) Subjects for HI Antibodies Secondary · At Days 21 and 42

Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 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).

Flu A/CAL/7/09, Day 21
GroupValue95% CI
GSK2340272A New 1D Group71
GSK2340272A New 2D Group62
GSK2340272A INI 1D Group65
GSK2340272A INI 2D Group61
Flu A/CAL/7/09, Day 42
GroupValue95% CI
GSK2340272A New 1D Group68
GSK2340272A New 2D Group62
GSK2340272A INI 1D Group65
GSK2340272A INI 2D Group62
Number of SCR Subjects for HI Antibodies Secondary · At Days 182 and 364

Seroconversion was defined as: For initially seronegative subjects \[antibody titer below (\<) 1:10 post to vaccination\], antibody titer greater than or equal to (≥) 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 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).

Flu A/CAL/7/09, Day 182
GroupValue95% CI
GSK2340272A New 1D Group60
GSK2340272A New 2D Group63
GSK2340272A INI 1D Group55
GSK2340272A INI 2D Group64
Flu A/CAL/7/09, Day 364
GroupValue95% CI
GSK2340272A New 1D Group43
GSK2340272A New 2D Group49
GSK2340272A INI 1D Group41
GSK2340272A INI 2D Group50
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Secondary · At Days 0, 21 and 42

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.

Flu A/CAL/7/09, Day 0
GroupValue95% CI
GSK2340272A New 1D Group6
GSK2340272A New 2D Group4
GSK2340272A INI 1D Group6
GSK2340272A INI 2D Group2
Flu A/CAL/7/09, Day 21
GroupValue95% CI
GSK2340272A New 1D Group73
GSK2340272A New 2D Group64
GSK2340272A INI 1D Group67
GSK2340272A INI 2D Group62
Flu A/CAL/7/09, Day 42
GroupValue95% CI
GSK2340272A New 1D Group71
GSK2340272A New 2D Group64
GSK2340272A INI 1D Group68
GSK2340272A INI 2D Group62
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain Secondary · At Days 182 and 364

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.

Flu A/CAL/7/09, Day 182
GroupValue95% CI
GSK2340272A New 1D Group63
GSK2340272A New 2D Group66
GSK2340272A INI 1D Group60
GSK2340272A INI 2D Group65
Flu A/CAL/7/09, Day 364
GroupValue95% CI
GSK2340272A New 1D Group47
GSK2340272A New 2D Group54
GSK2340272A INI 1D Group48
GSK2340272A INI 2D Group53
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Secondary · At Days 21 and 42

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

Flu A/CAL/7/09, Day 21
GroupValue95% CI
GSK2340272A New 1D Group37.428.8 – 48.6
GSK2340272A New 2D Group41.831.5 – 55.3
GSK2340272A INI 1D Group38.028.3 – 51.0
GSK2340272A INI 2D Group47.735.7 – 63.7
Flu A/CAL/7/09, Day 42
GroupValue95% CI
GSK2340272A New 1D Group26.220.2 – 33.9
GSK2340272A New 2D Group58.744.6 – 77.3
GSK2340272A INI 1D Group30.122.6 – 40.0
GSK2340272A INI 2D Group82.566.4 – 102.5
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Secondary · At Days 182 and 364

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

Flu A/CAL/7/09, Day 182
GroupValue95% CI
GSK2340272A New 1D Group12.19.6 – 15.3
GSK2340272A New 2D Group18.915.3 – 23.5
GSK2340272A INI 1D Group14.310.6 – 19.2
GSK2340272A INI 2D Group25.620.9 – 31.5
Flu A/CAL/7/09, Day 364
GroupValue95% CI
GSK2340272A New 1D Group7.66.0 – 9.8
GSK2340272A New 2D Group9.57.6 – 11.9
GSK2340272A INI 1D Group8.96.4 – 12.5
GSK2340272A INI 2D Group13.510.7 – 17.0

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 New 1D Group
Serious: 7/76 (9%)
Deaths: 0/76
GSK2340272A New 2D Group
Serious: 2/73 (3%)
Deaths: 0/73
GSK2340272A INI 1D Group
Serious: 3/76 (4%)
Deaths: 0/76
GSK2340272A INI 2D Group
Serious: 5/75 (7%)
Deaths: 0/75

Serious adverse events (23 terms)

ReactionSystemGSK2340272A New 1D GroupGSK2340272A New 2D GroupGSK2340272A INI 1D GroupGSK2340272A INI 2D Group
AsthmaRespiratory, thoracic and mediastinal disorders————
Bartholin's abscessInfections and infestations————
Bronchial hyperreactivityRespiratory, thoracic and mediastinal disorders————
Calculus urethralRenal and urinary disorders————
Cerebral haemorrhageNervous system disorders————
Cerebral thrombosisNervous system disorders————
Cholecystitis chronicHepatobiliary disorders————
Coronary artery diseaseCardiac disorders————
EpilepsyNervous system disorders————
Foot deformityMusculoskeletal and connective tissue disorders————
GastritisGastrointestinal disorders————
Limb injuryInjury, poisoning and procedural complications————
Malignant peritoneal neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)————
Osteitis deformansMusculoskeletal and connective tissue disorders————
OsteoarthritisMusculoskeletal and connective tissue disorders————
Pain in extremityMusculoskeletal and connective tissue disorders————
Peripheral vascular disorderVascular disorders————
Prostatic adenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)————
Radius fractureInjury, poisoning and procedural complications————
Rotator cuff syndromeMusculoskeletal and connective tissue disorders————
SalpingitisInfections and infestations————
Status epilepticusNervous system disorders————
Tachycardia paroxysmalCardiac disorders————
Other adverse events (14 terms — click to expand)

ReactionSystemGSK2340272A New 1D GroupGSK2340272A New 2D GroupGSK2340272A INI 1D GroupGSK2340272A INI 2D Group
PainGeneral disorders————
HeadacheNervous system disorders————
FatigueGeneral disorders————
ChillsGeneral disorders————
MyalgiaMusculoskeletal and connective tissue disorders————
ArthralgiaMusculoskeletal and connective tissue disorders————
HyperhidrosisSkin and subcutaneous tissue disorders————
NasopharyngitisInfections and infestations————
PyrexiaGeneral disorders————
SwellingGeneral disorders————
Upper respiratory tract infectionInfections and infestations————
ErythemaSkin and subcutaneous tissue disorders————
NauseaGastrointestinal disorders————
Oropharyngeal painRespiratory, thoracic and mediastinal disorders————

Most-reported serious reactions: Asthma, Bartholin's abscess, Bronchial hyperreactivity, Calculus urethral, Cerebral haemorrhage, Cerebral thrombosis, Cholecystitis chronic, Coronary artery disease.

Data from ClinicalTrials.gov NCT00992511 adverse events section.

Sponsor's own description

The objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. 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

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