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NCT01001169

Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children

Completed Phase 2 Results posted Last updated 17 August 2018
What this trial tests

Phase 2 trial testing GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A) in Influenza in 60 participants. Completed in 17 May 2010.

Timeline
1 October 2009
Primary endpoint
17 May 2010
17 May 2010

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeprevention
Enrollment60
Start date1 October 2009
Primary completion17 May 2010
Estimated completion17 May 2010
Sites1 location across Japan

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.

Number of Subjects With Haemagglutination Inhibition (HI) Antibody Concentrations Above the Cut-off Value Primary · At Day 42

The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), in subjects aged between 6 months to 9 years and 10 to 17 years, following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance.

GroupValue95% CI
GSK2340274A_F1 6M-9Y Group28
GSK2340274A_F2 10Y-17Y Group30
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Primary · At Day 42

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

GroupValue95% CI
GSK2340274A_F1 6M-9Y Group939.3722.9 – 1220.6
GSK2340274A_F2 10Y-17Y Group874.3717.4 – 1065.4
Number of Seroconverted Subjects for HI Antibodies Primary · At Day 42

Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%. The CHMP criterion was fulfilled if the point estimate for SCR was \> 40%.

GroupValue95% CI
GSK2340274A_F1 6M-9Y Group28
GSK2340274A_F2 10Y-17Y Group30
Number of Seroprotected Subjects for HI Antibodies Primary · At Day 42

A seroprotected subject was defined as a vaccinated subject with a serum hemagglutination inhibition (HI) titer equal to or above (≥) 1:40. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for seroprotection (SPR) was \> 70%. The CHMP Criterion was fulfilled if the post-vaccination point estimate for SPR was \> 70%.

GroupValue95% CI
GSK2340274A_F1 6M-9Y Group28
GSK2340274A_F2 10Y-17Y Group30
Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Primary · At Day 42

GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP guidance. The CHMP Criterion was fulfilled if the point estimate for GMFR was \> 2.5.

GroupValue95% CI
GSK2340274A_F1 6M-9Y Group146.899.6 – 216.4
GSK2340274A_F2 10Y-17Y Group57.133.5 – 97.3
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value Secondary · At Days 0 and 21

The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

Flu A/CAL/7/09, Day 0
GroupValue95% CI
GSK2340274A_F1 6M-9Y Group5
GSK2340274A_F2 10Y-17Y Group18
GSK2340274A_F1 6M-35M Subgroup0
GSK2340274A_F1 3Y-9Y Subgroup5
Flu A/CAL/7/09, Day 21
GroupValue95% CI
GSK2340274A_F1 6M-9Y Group29
GSK2340274A_F2 10Y-17Y Group30
GSK2340274A_F1 6M-35M Subgroup10
GSK2340274A_F1 3Y-9Y Subgroup19
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value Secondary · At Days 0 and 42

The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.

Flu A/CAL/7/09, Day 0
GroupValue95% CI
GSK2340274A_F1 6M-35M Subgroup0
GSK2340274A_F1 3Y-9Y Subgroup5
Flu A/CAL/7/09, Day 42
GroupValue95% CI
GSK2340274A_F1 6M-35M Subgroup9
GSK2340274A_F1 3Y-9Y Subgroup19
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value Secondary · At Days 0 and 182

The cut-off values for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

Flu A/CAL/7/09, Day 0
GroupValue95% CI
GSK2340274A_F1 6M-9Y Group5
GSK2340274A_F2 10Y-17Y Group17
GSK2340274A_F1 6M-35M Subgroup0
GSK2340274A_F1 3Y-9Y Subgroup5
Flu A/CAL/7/09, Day 182
GroupValue95% CI
GSK2340274A_F1 6M-9Y Group28
GSK2340274A_F2 10Y-17Y Group29
GSK2340274A_F1 6M-35M Subgroup9
GSK2340274A_F1 3Y-9Y Subgroup19
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Secondary · At Days 0 and 21

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

Flu A/CAL/7/09, Day 0
GroupValue95% CI
GSK2340274A_F1 6M-9Y Group6.35.0 – 8.1
GSK2340274A_F2 10Y-17Y Group15.39.5 – 24.6
GSK2340274A_F1 6M-35M SubgroupNANA – NA
GSK2340274A_F1 3Y-9Y Subgroup7.25.0 – 10.3
Flu A/CAL/7/09, Day 21
GroupValue95% CI
GSK2340274A_F1 6M-9Y Group172.0130.1 – 227.6
GSK2340274A_F2 10Y-17Y Group339.0238.8 – 481.2
GSK2340274A_F1 6M-35M Subgroup117.372.2 – 190.8
GSK2340274A_F1 3Y-9Y Subgroup210.4150.4 – 294.5
Titers for Serum 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 reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years, following the CHMP and the CBER guidance. Note: Analyses based on 95% CI for 10-17 year age category at Day 42 were not performed.

Flu A/CAL/7/09, Day 0
GroupValue95% CI
GSK2340274A_F1 6M-35M SubgroupNANA – NA
GSK2340274A_F1 3Y-9Y Subgroup7.25.0 – 10.3
Flu A/CAL/7/09, Day 42
GroupValue95% CI
GSK2340274A_F1 6M-35M Subgroup1279.9806.9 – 2030.4
GSK2340274A_F1 3Y-9Y Subgroup811.3628.4 – 1047.4
Titers for Serum HI Antibodies Against Flu A/CAL/7/09 Strain of Influenza Disease Secondary · At Days 0 and 182

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance.

Flu A/CAL/7/09, Day 0
GroupValue95% CI
GSK2340274A_F1 6M-9Y Group6.45.0 – 8.2
GSK2340274A_F2 10Y-17Y Group14.89.1 – 24.1
GSK2340274A_F1 6M-35M SubgroupNANA – NA
GSK2340274A_F1 3Y-9Y Subgroup7.25.0 – 10.3
Flu A/CAL/7/09, Day 182
GroupValue95% CI
GSK2340274A_F1 6M-9Y Group161.9133.7 – 196.1
GSK2340274A_F2 10Y-17Y Group347.9254.0 – 476.5
GSK2340274A_F1 6M-35M Subgroup154.0100.3 – 236.5
GSK2340274A_F1 3Y-9Y Subgroup165.8131.9 – 208.5
Number of Seroconverted Subjects for HI Antibodies Secondary · At Day 21

Seroconversion (SCR) was defined as follows: For initially seronegative subjects, antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The Flu strain assessed was Flu A/CAL/7/09, in subjects aged between 6 months to 9 years and 10 to 17 years, following the CHMP and the CBER guidance. The CHMP Criterion was fulfilled if the point estimate for SCR was \> 40%. The CBER Criterion was fulfilled if the lower 97.5% confidence interval for SCR was \> 40%.

GroupValue95% CI
GSK2340274A_F1 6M-9Y Group29
GSK2340274A_F2 10Y-17Y Group27
GSK2340274A_F1 6M-35M Subgroup10
GSK2340274A_F1 3Y-9Y Subgroup19

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local and general symptoms: during the 7-day (Day 0-6) post-vaccination period; Unsolicited AEs: up to 84 days (Days 0-83) after the first vaccination; SAEs: during the entire study period (from Day 0 up to Day 182).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

GSK2340274A_F1 6M-9Y Group
Serious: 1/30 (3%)
Deaths: —
GSK2340274A_F2 10Y-17Y Group
Serious: 1/30 (3%)
Deaths: —

Serious adverse events (2 terms)

ReactionSystemGSK2340274A_F1 6M-9Y GroupGSK2340274A_F2 10Y-17Y Group
Febrile convulsionNervous system disorders——
Foot fractureInjury, poisoning and procedural complications——
Other adverse events (30 terms — click to expand)

ReactionSystemGSK2340274A_F1 6M-9Y GroupGSK2340274A_F2 10Y-17Y Group
PainGeneral disorders——
Headache (6y-9y + 10y-17y)General disorders——
SwellingGeneral disorders——
Fatigue (6y-9y + 10y-17y)General disorders——
Muscle aches (6y-9y + 10y-17y)General disorders——
Shivering (6y-9y + 10y-17y)General disorders——
RednessGeneral disorders——
Temperature (Axillary)General disorders——
Joint pain (6y-9y + 10y-17y)General disorders——
Drowsiness (6m-5y)General disorders——
Irritability (6m-5y)General disorders——
Loss of appetite (6m-5y)General disorders——
CoughRespiratory, thoracic and mediastinal disorders——
RhinorrhoeaRespiratory, thoracic and mediastinal disorders——
PyrexiaGeneral disorders——
Upper respiratory tract infectionInfections and infestations——
Sweating (6y-9y + 10y-17y)General disorders——
Gastrointestinal (6y-9y + 10y-17y)General disorders——
DiarrhoeaGastrointestinal disorders——
GastroenteritisInfections and infestations——
NasopharyngitisInfections and infestations——
VomitingGastrointestinal disorders——
AcneSkin and subcutaneous tissue disorders——
Axillary painGeneral disorders——
BronchitisInfections and infestations——
Eye dischargeEye disorders——
HeadacheNervous system disorders——
InfluenzaInfections and infestations——
PharyngitisInfections and infestations——
Rhinitis allergicRespiratory, thoracic and mediastinal disorders——

Most-reported serious reactions: Febrile convulsion, Foot fracture.

Data from ClinicalTrials.gov NCT01001169 adverse events section.

Sponsor's own description

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational influenza vaccine GSK2340274A following one dose and following a second dose, using the same dosage as has been used in the H5N1 development program in Japanese children aged 10-17 years and an alternative dose in children aged 6 months to 9 years.

Publications & conference data

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

  1. Safety and persistence of immunological response 6 months after intramuscular vaccination with an AS03-adjuvanted H1N1 2009 influenza vaccine: an open-label, randomized trial in Japanese children aged 6 months to 17 years.
    Saitoh A, Nagai A, Tenjinbaru K, Li P, et al · · 2012 · cited 9× · PMID 22495117 · DOI 10.4161/hv.19684

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