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NCT00971321

Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

Completed Phase 2 Results posted Last updated 25 February 2019
What this trial tests

Phase 2 trial testing Pandemic influenza vaccine GSK2340272A in Influenza in 157 participants. Completed in 24 November 2010.

Timeline
10 September 2009
Primary endpoint
24 November 2010
24 November 2010

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment157
Start date10 September 2009
Primary completion24 November 2010
Estimated completion24 November 2010
Sites5 locations across Spain

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.

Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Primary · At Day 0

Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

GroupValue95% CI
GSK2340272A F1 Group5
GSK2340272A F2 Group6
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Primary · At Day 42

Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

GroupValue95% CI
GSK2340272A F1 Group97
GSK2340272A F2 Group50
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies Primary · At Day 0

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

GroupValue95% CI
GSK2340272A F1 Group5.755.00 – 6.63
GSK2340272A F2 Group6.825.22 – 8.91
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies Primary · At Day 42

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

GroupValue95% CI
GSK2340272A F1 Group2007.701805.24 – 2232.87
GSK2340272A F2 Group2259.611947.61 – 2621.59
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibodies Primary · At Day 42

Seroconversion (SCR) was defined as the percentage of vaccinees that have 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 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).

GroupValue95% CI
GSK2340272A F1 Group97
GSK2340272A F2 Group48
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Primary · At Day 42

Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).

GroupValue95% CI
GSK2340272A F1 Group97
GSK2340272A F2 Group50
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers Primary · At Day 42

Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).

GroupValue95% CI
GSK2340272A F1 Group346.86287.54 – 418.42
GSK2340272A F2 Group322.67231.61 – 449.52
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Secondary · At Days 0, 21, 42, and at Month 11-12

Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Flu A/CAL/7/2009, Day 0
GroupValue95% CI
GSK2340272A F1 Group4
GSK2340272A F2 Group4
Flu A/CAL/7/2009, Day 21
GroupValue95% CI
GSK2340272A F1 Group83
GSK2340272A F2 Group37
Flu A/CAL/7/2009, Day 42
GroupValue95% CI
GSK2340272A F1 Group83
GSK2340272A F2 Group37
Flu A/CAL/7/2009, Month 11-12
GroupValue95% CI
GSK2340272A F1 Group83
GSK2340272A F2 Group37
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies Secondary · At Days 0, 21, 42 and at Month 11-12

Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).

Flu A/CAL/7/2009, Day 0
GroupValue95% CI
GSK2340272A F1 Group5.85.0 – 6.8
GSK2340272A F2 Group6.25.0 – 7.8
Flu A/CAL/7/2009, Day 21
GroupValue95% CI
GSK2340272A F1 Group234.0202.9 – 269.8
GSK2340272A F2 Group255.5205.4 – 317.9
Flu A/CAL/7/2009, Day 42
GroupValue95% CI
GSK2340272A F1 Group1758.01553.8 – 1989.1
GSK2340272A F2 Group1879.21504.2 – 2347.7
Flu A/CAL/7/2009, Month 11-12
GroupValue95% CI
GSK2340272A F1 Group212.5182.8 – 247.0
GSK2340272A F2 Group239.3201.6 – 284.0
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers Secondary · At Days 21, 42 and at Month 11-12

Seroconversion (SCR) was defined as the percentage of vaccinees that have 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 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).

Flu A/CAL/7/2009, Day 21
GroupValue95% CI
GSK2340272A F1 Group82
GSK2340272A F2 Group37
Flu A/CAL/7/2009, Day 42
GroupValue95% CI
GSK2340272A F1 Group83
GSK2340272A F2 Group37
Flu A/CAL/7/2009, Month 11-12
GroupValue95% CI
GSK2340272A F1 Group81
GSK2340272A F2 Group36
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies Secondary · At Days 0, 21, 42 and at Month 11-12

Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).

Flu A/CAL/7/2009, Day 0
GroupValue95% CI
GSK2340272A F1 Group3
GSK2340272A F2 Group3
Flu A/CAL/7/2009, Day 21
GroupValue95% CI
GSK2340272A F1 Group83
GSK2340272A F2 Group37
Flu A/CAL/7/2009, Day 42
GroupValue95% CI
GSK2340272A F1 Group83
GSK2340272A F2 Group37
Flu A/CAL/7/2009, Month 11-12
GroupValue95% CI
GSK2340272A F1 Group83
GSK2340272A F2 Group37
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers Secondary · At Days 21, 42 and at Month 11-12

Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).

Flu A/CAL/7/2009, Day 21
GroupValue95% CI
GSK2340272A F1 Group40.334.3 – 47.2
GSK2340272A F2 Group41.232.2 – 52.7
Flu A/CAL/7/2009, Day 42
GroupValue95% CI
GSK2340272A F1 Group302.5248.2 – 368.7
GSK2340272A F2 Group302.8211.8 – 432.9
Flu A/CAL/7/2009, Month 11-12
GroupValue95% CI
GSK2340272A F1 Group36.630.0 – 44.6
GSK2340272A F2 Group38.629.5 – 50.4

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: during a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84); SAEs: during the entire study period (Day 0 up to Month 11-12).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK 2340272A F1 Group
Serious: 2/104 (2%)
Deaths: 0/104
GSK 2340272A F2 Group
Serious: 6/53 (11%)
Deaths: 0/53

Serious adverse events (10 terms)

ReactionSystemGSK 2340272A F1 GroupGSK 2340272A F2 Group
LymphadenitisBlood and lymphatic system disorders——
BronchiolitisInfections and infestations——
BronchitisInfections and infestations——
ConjunctivitisInfections and infestations——
Otitis mediaInfections and infestations——
PneumoniaInfections and infestations——
Viral rashInfections and infestations——
Craniocerebral injuryInjury, poisoning and procedural complications——
AsthmaRespiratory, thoracic and mediastinal disorders——
BronchospasmRespiratory, thoracic and mediastinal disorders——
Other adverse events (23 terms — click to expand)

ReactionSystemGSK 2340272A F1 GroupGSK 2340272A F2 Group
PyrexiaGeneral disorders——
IrritabilityPsychiatric disorders——
Upper respiratory tract infectionInfections and infestations——
Decreased appetiteMetabolism and nutrition disorders——
PainGeneral disorders——
SomnolenceNervous system disorders——
ErythemaSkin and subcutaneous tissue disorders——
SwellingGeneral disorders——
DiarrhoeaGastrointestinal disorders——
CoughRespiratory, thoracic and mediastinal disorders——
BronchitisInfections and infestations——
GastroenteritisInfections and infestations——
PharyngitisInfections and infestations——
Otitis media acuteInfections and infestations——
VomitingGastrointestinal disorders——
RashSkin and subcutaneous tissue disorders——
ConjunctivitisInfections and infestations——
LaryngitisInfections and infestations——
Otitis mediaInfections and infestations——
AsthmaRespiratory, thoracic and mediastinal disorders——
Respiratory tract infectionInfections and infestations——
RhinitisInfections and infestations——
TonsillitisInfections and infestations——

Most-reported serious reactions: Lymphadenitis, Bronchiolitis, Bronchitis, Conjunctivitis, Otitis media, Pneumonia, Viral rash, Craniocerebral injury.

Data from ClinicalTrials.gov NCT00971321 adverse events section.

Sponsor's own description

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months. This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.

Publications & conference data

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

  1. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies.
    Garcia-Sicilia J, Arístegui J, Omeñaca F, Carmona A, et al · · 2015 · cited 7× · PMID 26176592 · DOI 10.1080/21645515.2015.1063754

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