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NCT01218308

A Study to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine in Children

Completed Phase 3 Results posted Last updated 1 August 2018
What this trial tests

Phase 3 trial testing FluLaval® Quadrivalent in Influenza in 5,220 participants. Completed in 9 January 2012.

Timeline
9 December 2010
Primary endpoint
9 January 2012
9 January 2012

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment5,220
Start date9 December 2010
Primary completion9 January 2012
Estimated completion9 January 2012
Sites12 locations across Panama, Dominican Republic, Honduras, Philippines, Thailand, Lebanon, Bangladesh, Turkey (Türkiye)

Drugs / interventions tested

Conditions studied

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 3 to 8, 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 Reporting at Least One Confirmed Occurrence of Influenza A or B. Primary · From Day 14 to Day 180

To confirm influenza A and/or B disease, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.

GroupValue95% CI
FluLaval® Quadrivalent Group58
Havrix Group128
Number of Subjects Reporting at Least One Moderate to Severe Occurrence of Influenza A or B. Secondary · From Day 14 to Day 180

To confirm influenza A and/or B disease moderate to severe cases, a positive RT-PCR result for influenza A or B virus from a nose and throat swab obtained concurrently with an ILI was required. Moderate to severe influenza was defined as RT-PCR-confirmed ILI with: * Fever \>39°C, and/or at least one of the following manifestations, * Physician-verified shortness of breath, pulmonary congestion, pneumonia, bronchiolitis, bronchitis, wheezing, croup, or acute otitis media, and/or one of the following, * Physician-diagnosed serious extra-pulmonary complication of influenza, including myositis, e

GroupValue95% CI
FluLaval® Quadrivalent Group14
Havrix Group52
Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Antigenically Matched Strain. Secondary · From Day 14 to Day 180

To confirm influenza A and/or B disease due to antigenically matched strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.

GroupValue95% CI
FluLaval® Quadrivalent Group31
Havrix Group56
Number of Subjects Reporting at Least One Culture Confirmed Occurrence of Influenza A or B Due to Any Strain. Secondary · From Day 14 to Day 180

To confirm influenza A and/or B disease due to any strain, a positive reverse transcriptase polymerase chain reaction (RT-PCR) result for influenza A or B virus from a nose and throat swab obtained concurrently with an influenza like illness (ILI) was required. ILI was defined as the presence of an oral or axillary temperature ≥ 37.8 degrees Celsius (°C) in the presence of at least one of the following symptoms on the same day: cough, sore throat, runny nose or nasal congestion.

GroupValue95% CI
FluLaval® Quadrivalent Group50
Havrix Group112
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. Secondary · At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]

Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

H1N1, PRE [N=457;117]
GroupValue95% CI
FluLaval® Quadrivalent Group15.313.6 – 17.3
Havrix Group16.112.6 – 20.5
H1N1, POST [N=457;121]
GroupValue95% CI
FluLaval® Quadrivalent Group318.8291.0 – 349.2
Havrix Group16.112.8 – 20.2
H3N2, PRE [N=457;117]
GroupValue95% CI
FluLaval® Quadrivalent Group24.321.9 – 27.0
Havrix Group28.623.5 – 34.8
H3N2, POST [N=457;122]
GroupValue95% CI
FluLaval® Quadrivalent Group264.7244.3 – 286.8
Havrix Group30.324.8 – 36.9
Victoria, PRE [N=457;117]
GroupValue95% CI
FluLaval® Quadrivalent Group13.712.2 – 15.4
Havrix Group15.612.2 – 20.1
Victoria, POST [N=457;120]
GroupValue95% CI
FluLaval® Quadrivalent Group239.9214.6 – 268.2
Havrix Group17.813.7 – 23.1
Yamagata, PRE [N=457;117]
GroupValue95% CI
FluLaval® Quadrivalent Group16.214.3 – 18.4
Havrix Group18.814.4 – 24.5
Yamagata, POST [N=457;117]
GroupValue95% CI
FluLaval® Quadrivalent Group361.5330.7 – 395.3
Havrix Group19.214.9 – 24.7
Number of Seroconverted Subjects Against 4 Strains of Influenza Disease. Secondary · At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]

A seroconverted subject was defined as a vaccinated subject who had 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 four-fold increase in post-vaccination titer. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

H1N1, POST
GroupValue95% CI
FluLaval® Quadrivalent Group438
Havrix Group1
H3N2, POST
GroupValue95% CI
FluLaval® Quadrivalent Group385
Havrix Group2
Victoria, POST
GroupValue95% CI
FluLaval® Quadrivalent Group425
Havrix Group3
Yamagata, POST
GroupValue95% CI
FluLaval® Quadrivalent Group435
Havrix Group1
Number of Seroprotected Subjects Against 4 Strains of Influenza Disease. Secondary · At Day 0 [PRE] and 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]

A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

H1N1, PRE [N=457;117]
GroupValue95% CI
FluLaval® Quadrivalent Group151
Havrix Group37
H1N1, POST [N=457;121]
GroupValue95% CI
FluLaval® Quadrivalent Group451
Havrix Group39
H3N2, PRE [N=457;117]
GroupValue95% CI
FluLaval® Quadrivalent Group205
Havrix Group63
H3N2, POST [N=457;122]
GroupValue95% CI
FluLaval® Quadrivalent Group445
Havrix Group63
Victoria, PRE [N=457;117]
GroupValue95% CI
FluLaval® Quadrivalent Group127
Havrix Group35
Victoria, POST [N=457;120]
GroupValue95% CI
FluLaval® Quadrivalent Group443
Havrix Group38
Yamagata, PRE [N=457;117]
GroupValue95% CI
FluLaval® Quadrivalent Group159
Havrix Group45
Yamagata, POST [N=457;117]
GroupValue95% CI
FluLaval® Quadrivalent Group452
Havrix Group45
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease. Secondary · At 28 days post vaccination (Day 28 for primed subjects and day 56 for unprimed subjects) [POST]

The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

H1N1, POST
GroupValue95% CI
FluLaval® Quadrivalent Group20.819.0 – 22.8
Havrix Group1.00.9 – 1.1
H3N2, POST
GroupValue95% CI
FluLaval® Quadrivalent Group10.99.8 – 12.1
Havrix Group1.00.9 – 1.2
Victoria, POST
GroupValue95% CI
FluLaval® Quadrivalent Group17.516.0 – 19.1
Havrix Group1.11.0 – 1.3
Yamagata, POST
GroupValue95% CI
FluLaval® Quadrivalent Group22.320.1 – 24.8
Havrix Group1.01.0 – 1.1
Haemagglutination Inhibition (HI) Antibody Titers Against Each of the 4 Vaccine Strains Secondary · On Day 0 and at least 6 months after first vaccination (Month 6)

HI antibody titres were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/California/7/2009 (H1N1), Flu A/Victoria/210/09 (H3N2), Flu B/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

H1N1, PRE [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group15.513.8 – 17.6
Havrix Group16.512.9 – 21.2
H1N1, POST [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group138.6122.6 – 156.6
Havrix Group23.217.9 – 30.1
H3N2, PRE [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group24.622.1 – 27.4
Havrix Group29.123.8 – 35.5
H3N2, POST [N=443;112]
GroupValue95% CI
FluLaval® Quadrivalent Group136.5124.3 – 149.9
Havrix Group43.634.9 – 54.5
Victoria, PRE [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group13.712.2 – 15.4
Havrix Group15.111.8 – 19.5
Victoria, POST [N=443;112]
GroupValue95% CI
FluLaval® Quadrivalent Group110.297.1 – 125.0
Havrix Group19.715.0 – 25.8
Yamagata, PRE [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group16.114.2 – 18.4
Havrix Group18.714.3 – 24.6
Yamagata, POST [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group157.0143.1 – 172.3
Havrix Group21.816.5 – 28.9
Number of Seroconverted Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. Secondary · At least 6 months after first vaccination (Month 6)

A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (\<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

H1N1, POST [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group349
Havrix Group9
H3N2, POST [N=443;112]
GroupValue95% CI
FluLaval® Quadrivalent Group290
Havrix Group10
Victoria, POST [N=443;112]
GroupValue95% CI
FluLaval® Quadrivalent Group323
Havrix Group12
Yamagata, POST [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group354
Havrix Group8
Number of Seroprotected Subjects for HI Antibody Titers Against Each of the 4 Vaccine Influenza Strains. Secondary · At Day 0 and at least 6 months after first vaccination (Month 6)

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 in adults. The vaccine strains assessed were Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

H1N1, PRE [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group148
Havrix Group36
H1N1, POST [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group383
Havrix Group49
H3N2, PRE [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group204
Havrix Group60
H3N2, POST [N=443;112]
GroupValue95% CI
FluLaval® Quadrivalent Group412
Havrix Group71
Victoria, PRE [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group123
Havrix Group32
Victoria, POST [N=443;112]
GroupValue95% CI
FluLaval® Quadrivalent Group374
Havrix Group39
Yamagata, PRE [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group153
Havrix Group43
Yamagata, POST [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group427
Havrix Group49
Seroconversion Factors for HI Antibodies Against 4 Strains of Influenza Disease. Secondary · At least 6 months after first vaccination (Month 6)

Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The 4 influenza strains assessed were the Flu A/California/7/09 (H1N1), Flu A/Victoria/210/09 (H3N2), FluB/Brisbane/60/08 (Victoria) and Flu B/Florida/4/06 (Yamagata).

H1N1, POST [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group8.98.1 – 9.8
Havrix Group1.41.2 – 1.6
H3N2, POST [N=443;112]
GroupValue95% CI
FluLaval® Quadrivalent Group5.55.0 – 6.1
Havrix Group1.51.2 – 1.8
Victoria, POST [N=443;112
GroupValue95% CI
FluLaval® Quadrivalent Group8.07.3 – 8.9
Havrix Group1.31.1 – 1.6
Yamagata, POST [N=444;112]
GroupValue95% CI
FluLaval® Quadrivalent Group9.78.7 – 10.8
Havrix Group1.21.0 – 1.4

Adverse events — posted to ClinicalTrials.gov

Time frame: SAEs: during the entire study period (Day 0-Day 180); Unsolicited AEs: during the 28-day (Day 0-Day 27) follow-up period after vaccination; Solicited local/general symptoms: during the 7-day (Day 0-Day 6) follow-up period after any vaccination.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

FluLaval® Quadrivalent Group
Serious: 36/2584 (1%)
Deaths: —
Havrix Group
Serious: 24/2584 (1%)
Deaths: —

Serious adverse events (40 terms)

ReactionSystemFluLaval® Quadrivalent GroupHavrix Group
GastroenteritisInfections and infestations——
PneumoniaInfections and infestations——
Animal biteInjury, poisoning and procedural complications——
Dengue feverInfections and infestations——
Urinary tract infectionInfections and infestations——
BronchopneumoniaInfections and infestations——
Upper respiratory tract infectionInfections and infestations——
BronchitisInfections and infestations——
AmoebiasisInfections and infestations——
ConvulsionNervous system disorders——
DrowningGeneral disorders——
Influenza like illnessGeneral disorders——
Acute tonsillitisInfections and infestations——
Amoebic dysenteryInfections and infestations——
Animal scratchInjury, poisoning and procedural complications——
AppendicitisInfections and infestations——
AsthmaRespiratory, thoracic and mediastinal disorders——
Bronchial hyperreactivityRespiratory, thoracic and mediastinal disorders——
Bronchial obstructionRespiratory, thoracic and mediastinal disorders——
BronchiolitisInfections and infestations——
BronchospasmRespiratory, thoracic and mediastinal disorders——
CellulitisInfections and infestations——
Croup infectiousInfections and infestations——
Diarrhoea infectiousInfections and infestations——
EndocarditisInfections and infestations——
Other adverse events (12 terms — click to expand)

ReactionSystemFluLaval® Quadrivalent GroupHavrix Group
PainGeneral disorders——
Muscle achesGeneral disorders——
HeadacheGeneral disorders——
NasopharyngitisInfections and infestations——
FatigueGeneral disorders——
Gastro.General disorders——
CoughRespiratory, thoracic and mediastinal disorders——
Joint painGeneral disorders——
Loss of appetiteGeneral disorders——
IrritabilityGeneral disorders——
DrowsinessGeneral disorders——
TemperatureGeneral disorders——

Most-reported serious reactions: Gastroenteritis, Pneumonia, Animal bite, Dengue fever, Urinary tract infection, Bronchopneumonia, Upper respiratory tract infection, Bronchitis.

Data from ClinicalTrials.gov NCT01218308 adverse events section.

Sponsor's own description

This study is designed to test the efficacy of an investigational influenza vaccine, in children compared to Havrix®, a licensed Hepatitis A virus vaccine. This study will also evaluate the immunogenicity and safety of the investigational vaccine.

Publications & conference data

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

  1. Vaccine for prevention of mild and moderate-to-severe influenza in children.
    Jain VK, Rivera L, Zaman K, Espos RA, et al · · 2013 · cited 107× · PMID 24328444 · DOI 10.1056/nejmoa1215817
  2. Hemagglutination Inhibition Antibody Titers as Mediators of Influenza Vaccine Efficacy Against Symptomatic Influenza A(H1N1), A(H3N2), and B/Victoria Virus Infections.
    Lim WW, Feng S, Wong SS, Sullivan SG, et al · · 2024 · cited 8× · PMID 39052734 · DOI 10.1093/infdis/jiae122

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Trials by the same sponsor.

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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/NCT01218308.

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