- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01992107
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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Alabama
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Huntsville, Alabama, Verenigde Staten, 35802
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Mobile, Alabama, Verenigde Staten, 36608
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Arizona
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Chandler, Arizona, Verenigde Staten, 85224
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Mesa, Arizona, Verenigde Staten, 85206
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Mesa, Arizona, Verenigde Staten, 85213
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Arkansas
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Harrisburg, Arkansas, Verenigde Staten, 72452
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Jonesboro, Arkansas, Verenigde Staten, 72401
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California
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Anaheim, California, Verenigde Staten, 92804
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Anaheim, California, Verenigde Staten, 92801
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Downey, California, Verenigde Staten, 90241
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Garden Grove, California, Verenigde Staten, 92844
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Modesto, California, Verenigde Staten, 95350
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Paramount, California, Verenigde Staten, 90723
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Sacramento, California, Verenigde Staten, 95816
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San Diego, California, Verenigde Staten, 92103-6204
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San Francisco, California, Verenigde Staten, 94102
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Santa Rosa, California, Verenigde Staten, 95405
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West Covina, California, Verenigde Staten, 91790
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80907
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Denver, Colorado, Verenigde Staten, 80246
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Denver, Colorado, Verenigde Staten, 80249
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Thornton, Colorado, Verenigde Staten, 80233
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Florida
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Boca Raton, Florida, Verenigde Staten, 33432
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Lake Mary, Florida, Verenigde Staten, 32746
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Melbourne, Florida, Verenigde Staten, 32935
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Miami Beach, Florida, Verenigde Staten, 33141
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Opa Locka, Florida, Verenigde Staten, 33055
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Pinellas Park, Florida, Verenigde Staten, 33781
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30338
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Marietta, Georgia, Verenigde Staten, 30062
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Woodstock, Georgia, Verenigde Staten, 30189
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Idaho
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Boise, Idaho, Verenigde Staten, 83642
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Illinois
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Peoria, Illinois, Verenigde Staten, 61602
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Indiana
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Mishawaka, Indiana, Verenigde Staten, 46545
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Iowa
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Council Bluffs, Iowa, Verenigde Staten, 51503
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Kansas
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Newton, Kansas, Verenigde Staten, 67114
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Wichita, Kansas, Verenigde Staten, 67207
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Wichita, Kansas, Verenigde Staten, 67010
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40509
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Louisville, Kentucky, Verenigde Staten, 40291
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Louisiana
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Metairie, Louisiana, Verenigde Staten, 70006
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64114
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St. Louis, Missouri, Verenigde Staten, 63141
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Nebraska
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Bellevue, Nebraska, Verenigde Staten, 68005
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Fremont, Nebraska, Verenigde Staten, 68025
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Omaha, Nebraska, Verenigde Staten, 68114
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Omaha, Nebraska, Verenigde Staten, 68134
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Nevada
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Las Vegas, Nevada, Verenigde Staten, 89104
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New York
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Binghamton, New York, Verenigde Staten, 13901
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North Carolina
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Wilmington, North Carolina, Verenigde Staten, 28401
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Ohio
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Akron, Ohio, Verenigde Staten, 44311
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Cincinnati, Ohio, Verenigde Staten, 45249
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Cleveland, Ohio, Verenigde Staten, 44106
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Cleveland, Ohio, Verenigde Staten, 44122
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Dayton, Ohio, Verenigde Staten, 45414
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Dayton, Ohio, Verenigde Staten, 45406
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Kettering, Ohio, Verenigde Staten, 45429
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73112
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Oklahoma City, Oklahoma, Verenigde Staten, 73103
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Tulsa, Oklahoma, Verenigde Staten, 74127
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Pennsylvania
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Erie, Pennsylvania, Verenigde Staten, 16505
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Erie, Pennsylvania, Verenigde Staten, 16508
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Hermitage, Pennsylvania, Verenigde Staten, 16148
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Sellersville, Pennsylvania, Verenigde Staten, 18960
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Upper St. Clair, Pennsylvania, Verenigde Staten, 15241
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South Carolina
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Anderson, South Carolina, Verenigde Staten, 29621
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Charleston, South Carolina, Verenigde Staten, 29403
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Mt. Pleasant, South Carolina, Verenigde Staten, 29464
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Tennessee
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Bristol, Tennessee, Verenigde Staten, 37620
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Jefferson City, Tennessee, Verenigde Staten, 37760
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Lebanon, Tennessee, Verenigde Staten, 37087
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Nashville, Tennessee, Verenigde Staten, 37203
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Texas
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Austin, Texas, Verenigde Staten, 78705
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Dallas, Texas, Verenigde Staten, 75231
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Fort Worth, Texas, Verenigde Staten, 76107
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Fort Worth, Texas, Verenigde Staten, 76135
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Round Rock, Texas, Verenigde Staten, 78681
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San Angelo, Texas, Verenigde Staten, 76904
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San Antonio, Texas, Verenigde Staten, 78229
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Utah
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Draper, Utah, Verenigde Staten, 84020
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Layton, Utah, Verenigde Staten, 84041
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Salt Lake City, Utah, Verenigde Staten, 84121
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Salt Lake City, Utah, Verenigde Staten, 84109
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Salt Lake City, Utah, Verenigde Staten, 84124
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South Jordan, Utah, Verenigde Staten, 84095
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West Jordan, Utah, Verenigde Staten, 84088
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Virginia
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Burke, Virginia, Verenigde Staten, 22015
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Charlottesville, Virginia, Verenigde Staten, 22902
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Actieve vergelijker: 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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Actieve vergelijker: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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.
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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 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
Tijdsspanne: 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 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- V130_03
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