Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old
A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate Safety and Immunogenicity of Cell-Based Quadrivalent Subunit Influenza Virus Vaccine and Cell-Based Trivalent Subunit Influenza Virus Vaccines in Subjects Ages ≥4 Years to < 18 Years
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Alabama
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Huntsville, Alabama, Spojené státy, 35802
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Mobile, Alabama, Spojené státy, 36608
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Arizona
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Chandler, Arizona, Spojené státy, 85224
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Mesa, Arizona, Spojené státy, 85206
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Mesa, Arizona, Spojené státy, 85213
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Arkansas
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Harrisburg, Arkansas, Spojené státy, 72452
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Jonesboro, Arkansas, Spojené státy, 72401
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California
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Anaheim, California, Spojené státy, 92804
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Anaheim, California, Spojené státy, 92801
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Downey, California, Spojené státy, 90241
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Garden Grove, California, Spojené státy, 92844
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Modesto, California, Spojené státy, 95350
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Paramount, California, Spojené státy, 90723
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Sacramento, California, Spojené státy, 95816
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San Diego, California, Spojené státy, 92103-6204
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San Francisco, California, Spojené státy, 94102
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Santa Rosa, California, Spojené státy, 95405
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West Covina, California, Spojené státy, 91790
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Colorado
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Colorado Springs, Colorado, Spojené státy, 80907
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Denver, Colorado, Spojené státy, 80246
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Denver, Colorado, Spojené státy, 80249
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Thornton, Colorado, Spojené státy, 80233
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Florida
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Boca Raton, Florida, Spojené státy, 33432
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Lake Mary, Florida, Spojené státy, 32746
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Melbourne, Florida, Spojené státy, 32935
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Miami Beach, Florida, Spojené státy, 33141
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Opa Locka, Florida, Spojené státy, 33055
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Pinellas Park, Florida, Spojené státy, 33781
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Georgia
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Atlanta, Georgia, Spojené státy, 30338
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Marietta, Georgia, Spojené státy, 30062
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Woodstock, Georgia, Spojené státy, 30189
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Idaho
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Boise, Idaho, Spojené státy, 83642
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Illinois
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Peoria, Illinois, Spojené státy, 61602
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Indiana
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Mishawaka, Indiana, Spojené státy, 46545
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Iowa
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Council Bluffs, Iowa, Spojené státy, 51503
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Kansas
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Newton, Kansas, Spojené státy, 67114
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Wichita, Kansas, Spojené státy, 67207
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Wichita, Kansas, Spojené státy, 67010
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Kentucky
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Lexington, Kentucky, Spojené státy, 40509
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Louisville, Kentucky, Spojené státy, 40291
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Louisiana
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Metairie, Louisiana, Spojené státy, 70006
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Missouri
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Kansas City, Missouri, Spojené státy, 64114
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St. Louis, Missouri, Spojené státy, 63141
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Nebraska
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Bellevue, Nebraska, Spojené státy, 68005
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Fremont, Nebraska, Spojené státy, 68025
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Omaha, Nebraska, Spojené státy, 68114
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Omaha, Nebraska, Spojené státy, 68134
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Nevada
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Las Vegas, Nevada, Spojené státy, 89104
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New York
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Binghamton, New York, Spojené státy, 13901
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North Carolina
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Wilmington, North Carolina, Spojené státy, 28401
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Ohio
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Akron, Ohio, Spojené státy, 44311
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Cincinnati, Ohio, Spojené státy, 45249
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Cleveland, Ohio, Spojené státy, 44106
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Cleveland, Ohio, Spojené státy, 44122
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Dayton, Ohio, Spojené státy, 45414
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Dayton, Ohio, Spojené státy, 45406
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Kettering, Ohio, Spojené státy, 45429
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Oklahoma
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Oklahoma City, Oklahoma, Spojené státy, 73112
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Oklahoma City, Oklahoma, Spojené státy, 73103
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Tulsa, Oklahoma, Spojené státy, 74127
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Pennsylvania
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Erie, Pennsylvania, Spojené státy, 16505
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Erie, Pennsylvania, Spojené státy, 16508
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Hermitage, Pennsylvania, Spojené státy, 16148
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Sellersville, Pennsylvania, Spojené státy, 18960
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Upper St. Clair, Pennsylvania, Spojené státy, 15241
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South Carolina
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Anderson, South Carolina, Spojené státy, 29621
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Charleston, South Carolina, Spojené státy, 29403
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Mt. Pleasant, South Carolina, Spojené státy, 29464
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Tennessee
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Bristol, Tennessee, Spojené státy, 37620
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Jefferson City, Tennessee, Spojené státy, 37760
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Lebanon, Tennessee, Spojené státy, 37087
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Nashville, Tennessee, Spojené státy, 37203
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Texas
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Austin, Texas, Spojené státy, 78705
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Dallas, Texas, Spojené státy, 75231
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Fort Worth, Texas, Spojené státy, 76107
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Fort Worth, Texas, Spojené státy, 76135
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Round Rock, Texas, Spojené státy, 78681
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San Angelo, Texas, Spojené státy, 76904
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San Antonio, Texas, Spojené státy, 78229
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Utah
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Draper, Utah, Spojené státy, 84020
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Layton, Utah, Spojené státy, 84041
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Salt Lake City, Utah, Spojené státy, 84121
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Salt Lake City, Utah, Spojené státy, 84109
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Salt Lake City, Utah, Spojené státy, 84124
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South Jordan, Utah, Spojené státy, 84095
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West Jordan, Utah, Spojené státy, 84088
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Virginia
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Burke, Virginia, Spojené státy, 22015
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Charlottesville, Virginia, Spojené státy, 22902
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Male or female aged 4 years to less than 18 years of age.
- Individual who had a parent or guardian who could give written informed consent after understanding the nature of the study and comply with study procedures and were available for follow-up.
- If the individual was of an age where, according to local regulations, informed assent is required, that individual had provided assent to participate in the study.
Exclusion Criteria:
- Individuals recently vaccinated against influenza
- Subjects with contraindications to receive influenza vaccine
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: QIVc (≥4 to <18 years)
Subjects received one or two doses of QIVc-Quadrivalent Cell-based Influenza Vaccine recommended for 2013-2014 season
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Novartis Investigational Quadrivalent Vaccine
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Aktivní komparátor: TIV1c (≥4 to <18 years)
Subjects received one or two doses of TIV1c (Trivalent Inactivated Cell-based Influenza Vaccine containing one strain from B lineage ("B1" strain) recommended for 2013-2014 season
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Licensed Influenza Vaccine
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Aktivní komparátor: TIV2c (≥4 to <18 years)
Subjects received one or two doses of TIV2c (Trivalent Inactivated Cell-based Influenza Vaccine containing B strain from the alternate lineage ("B2" strain) recommended for 2013-2014
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Novartis Investigational Vaccine
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c
Časové okno: Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Immunogenicity of QIVc to comparator TIV1c (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by hemagglutination inhibition (HI) assay, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c. Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5. |
Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c
Časové okno: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Immunogenicity of QIVc to comparator TIVc (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase (at least a 4-fold increase in HI titer in subjects seropositive at baseline [i.e., HI titer ≥1:10 at Day 1] ) in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
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Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Časové okno: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer. The Center for Biologics Evaluation, Research, and Review (CBER) criterion for an adult population is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% |
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Časové okno: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c. The CBER criterion for adult population was that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥1:40 should meet or exceed 70% |
Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Časové okno: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
|
Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer <1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
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Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years
Časové okno: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Immunogenicity was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing HI titer ≥1:40, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The Committee for Medicinal Products for Human Use (CHMP) criterion for an adult population was that the percentage of subjects achieving an HI titer ≥1:40 is >70%
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Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age
Časové okno: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Immunogenicity was measured in subjects (Previously vaccinated and Not previously vaccinated) as the geometric mean ratio (GMR).
The ratio of postvaccination to prevaccination HI GMTs, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c .For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c The CHMP criterion for GMR in adult population is >2.5
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Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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GMT in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c Against B2 Strain
Časové okno: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Immunogenicity of QIVc to comparator TIV1c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV1c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody did not exceed the superiority margin of 1 |
Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Percentages of Subjects Achieving Seroconversion Against B2 Strain After One or Two Doses of Either QIVc or TIV1c
Časové okno: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Immunogenicity of QIVc to comparator TIV1c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks after last vaccination with QIVc or TIV1c. Superiority criterion was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points |
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
|
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GMT in Subjects After Receiving One or Two Doses of Either QIVc,TIV2c Against B1 Strain
Časové okno: Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
|
Immunogenicity of QIVc to comparator TIV2c was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by HI assay, three weeks after last vaccination with one or two doses of either QIVc or TIV2c. Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1 |
Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc or TIV2c
Časové okno: Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
|
Immunogenicity of QIVc to comparator TIV2c in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks after last vaccination with QIVc or TIV2c. Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody does not exceed the margin of 0 points |
Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)
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Number of Subjects Reporting Solicited Adverse Events (AEs) After One or Two Doses of Either QIVc, TIV1c or TIV2c by Age Sub-strata
Časové okno: Day 1 to 7 after last vaccination
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Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting solicited local and systemic reactions, day 1 to 7 after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c.For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c.
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Day 1 to 7 after last vaccination
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Number of Subjects Reporting Unsolicited AEs After One or Two Doses of Either QIVc, TIV1c or TIV2c by Overall Age Group
Časové okno: Day 1 to 210 post vaccination
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Safety was assessed in terms of number of subjects (Previously vaccinated and Not previously vaccinated) reporting unsolicited AEs (day 1 to 22 for Previously vaccinated and day 1 to day 50 for Not previously vaccinated subjects), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 for Previously vaccinated and day 1 to day 210 for Not previously vaccinated subjects) after receiving one or two doses of either QIVc, TIV1c or TIV2c.
For A/H1N1, A/H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c.
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Day 1 to 210 post vaccination
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- V130_03
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