Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
19. april 2017 opdateret af: Novartis Vaccines
Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 2009 (swine flu) vaccine in healthy young children
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
654
Fase
- Fase 2
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arkansas
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Bentonville, Arkansas, Forenede Stater, 72712
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Fort Smith, Arkansas, Forenede Stater, 72903
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California
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Canoga Park, California, Forenede Stater, 91306
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Dinuba, California, Forenede Stater, 93618
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Fresno, California, Forenede Stater, 93703
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Long Beach, California, Forenede Stater, 90806
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Los Angeles, California, Forenede Stater, 90015
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Madera, California, Forenede Stater, 93637
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Torrance, California, Forenede Stater, 90503
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Indiana
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New Albany, Indiana, Forenede Stater, 47150
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Kansas
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Newton, Kansas, Forenede Stater, 67114
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Wichita, Kansas, Forenede Stater, 67207
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Kentucky
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Bardstown, Kentucky, Forenede Stater, 40004
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Massachusetts
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Woburn, Massachusetts, Forenede Stater, 01801
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North Dakota
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Fargo, North Dakota, Forenede Stater, 58104
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Ohio
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Dayton, Ohio, Forenede Stater, 45406
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Huber Heights, Ohio, Forenede Stater, 45424
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73103
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South Carolina
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Charleston, South Carolina, Forenede Stater, 29406
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Spartanburg, South Carolina, Forenede Stater, 29303
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Tennessee
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Lebanon, Tennessee, Forenede Stater, 37087
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Texas
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Dallas, Texas, Forenede Stater, 75230
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Houston, Texas, Forenede Stater, 77055
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Utah
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Provo, Utah, Forenede Stater, 84604
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Saint George, Utah, Forenede Stater, 84790
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South Jordan, Utah, Forenede Stater, 84095
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West Jordan, Utah, Forenede Stater, 84088
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22902
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Delegacion Tlalpan, Mexico, 14000
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 måneder til 2 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Children 6 to 35 months of age in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months
Exclusion Criteria:
- History of serious disease.
- History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
- Known or suspected impairment/alteration of immune function.
- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination
For additional entry criteria, please refer to protocol
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 3.75_(50)MF59
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
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3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
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Eksperimentel: 7.5_(0)MF59
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
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3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
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Eksperimentel: 7.5_(50)MF59
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
|
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Eksperimentel: 15_(0)MF59
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
|
3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Antibody Responses After the First and Second Vaccinations
Tidsramme: 21 days after each vaccination
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CBER guidance (<65 years of age): The lower bound of the two-sided 95% CI for the percent of subjects achieving seroconversion for HI antibody should be ≥ 40% AND the lower bound of the two sided 95% CI for the percent of subjects achieving an HI antibody titer ≥ 1:40 should be ≥ 70%.
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21 days after each vaccination
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Number of Participants Reporting Solicited Local and Systemic Reactions After First Vaccination
Tidsramme: Day 1 to 7
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Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after first vaccination.
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Day 1 to 7
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Number of Participants Reporting Solicited Local and Systemic Reactions After Second Vaccination
Tidsramme: Day 22 to 28
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Safety was measured in terms of the number of participants reporting solicited local and systemic reactions after second vaccination.
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Day 22 to 28
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Immunogenicity Measurement by Geometric Mean Titers (GMT)
Tidsramme: 21 days after each vaccination
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Immunogenicity was measured in terms of the GMT at 21 days after each vaccination.
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21 days after each vaccination
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Antibody Responses With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Tidsramme: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Subgroup analysis based on receipt of recent seasonal vaccination.
Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
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Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Geometric Mean Titers (GMTs) With and Without Seasonal Influenza Vaccination for Year 2009 to 2010
Tidsramme: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Subgroup analysis based on receipt of recent seasonal vaccination.
Comparison between subjects previously vaccinated versus not vaccinated with seasonal influenza vaccines.
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Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Antibody Response Based on Baseline Seropositivity
Tidsramme: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10
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Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Geometric Mean Titers (GMTs) Based on Baseline Seropositivity
Tidsramme: Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Subgroup analysis based on Subjects with a pre-vaccination HI antibody titer < 1:10 and prevaccination HI antibody titer ≥ 1:10 Immunogenicity responses in subjects who are seropositive (A/H1N1 2009 HI titer ≥ 1:10) at Baseline (Day 1 (pre-vaccination)) as compared to those who are seronegative (HI titer < 1:10).
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Day 22 (three weeks after first vaccination); day 43 (three weeks after second vaccination)
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Antibody Persistence by Geometric Mean Titers (GMT)
Tidsramme: 6 months (Day 202) and 12 months (Day 387) after second vaccination
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Immunogenicity was assessed in terms of Geometric Mean Titers (GMT at 6 months (Day 202)and 12 months (Day 387) after second vaccination.
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6 months (Day 202) and 12 months (Day 387) after second vaccination
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. oktober 2009
Primær færdiggørelse (Faktiske)
1. december 2009
Studieafslutning (Faktiske)
1. december 2010
Datoer for studieregistrering
Først indsendt
15. oktober 2009
Først indsendt, der opfyldte QC-kriterier
15. oktober 2009
Først opslået (Skøn)
16. oktober 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. april 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- V112_06
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