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Study to Assess the Immunogenicity and Safety of an Investigational Influenza Vaccine in Children

22. august 2018 oppdatert av: GlaxoSmithKline

Immunogenicity & Safety Study of GSK Biologicals' Thimerosal-free Trivalent Influenza Vaccine (TIV) Versus a Licensed Comparator in Children

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK1557482A.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

2116

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Alabama
      • Birmingham, Alabama, Forente stater, 35205
        • GSK Investigational Site
    • Arkansas
      • Benton, Arkansas, Forente stater, 72015
        • GSK Investigational Site
    • California
      • Huntington Beach, California, Forente stater, 92647
        • GSK Investigational Site
      • Paramount, California, Forente stater, 90723
        • GSK Investigational Site
      • West Covina, California, Forente stater, 91790
        • GSK Investigational Site
    • Georgia
      • Marietta, Georgia, Forente stater, 30062
        • GSK Investigational Site
      • Woodstock, Georgia, Forente stater, 30189
        • GSK Investigational Site
    • Illinois
      • DeKalb, Illinois, Forente stater, 60115
        • GSK Investigational Site
    • Kansas
      • Newton, Kansas, Forente stater, 67114
        • GSK Investigational Site
      • Wichita, Kansas, Forente stater, 67207
        • GSK Investigational Site
    • Massachusetts
      • Woburn, Massachusetts, Forente stater, 01801
        • GSK Investigational Site
    • Michigan
      • Stevensville, Michigan, Forente stater, 49127
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63141
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, Forente stater, 89015
        • GSK Investigational Site
    • New York
      • Cortland, New York, Forente stater, 13045
        • GSK Investigational Site
      • Syracuse, New York, Forente stater, 13210
        • GSK Investigational Site
    • North Carolina
      • Cary, North Carolina, Forente stater, 27518
        • GSK Investigational Site
      • Raleigh, North Carolina, Forente stater, 27609
        • GSK Investigational Site
    • Ohio
      • Austintown, Ohio, Forente stater, 44515
        • GSK Investigational Site
    • Oregon
      • Albany, Oregon, Forente stater, 97322
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Forente stater, 16505
        • GSK Investigational Site
      • Hermitage, Pennsylvania, Forente stater, 16148
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29406
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Forente stater, 78705
        • GSK Investigational Site
      • Houston, Texas, Forente stater, 77055
        • GSK Investigational Site
    • Utah
      • Orem, Utah, Forente stater, 84057
        • GSK Investigational Site
      • Provo, Utah, Forente stater, 84604
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, Forente stater, 22015
        • GSK Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

3 år til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects and/or subject parent(s)/Legally Acceptable Representative(s) (LAR) who the investigator believes can and will comply with the requirements of the protocol.
  • A male or female child aged between 3 years and 17 years of age at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
  • Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and history-directed clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations or registered and recommended pandemic influenza vaccine are not an exclusion.
  • Receipt of a seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
  • Child in care
  • Receipt of systemic glucocorticoids within 1 month prior to study enrollment, or any other cytotoxic or immunosuppressive drug within 6 months of study enrollment. Topical, intra-articular or inhaled glucocorticoids are allowed.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • History of hypersensitivity to any vaccine.
  • History of Guillain-Barré-syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • History of chronic alcohol consumption and/or drug abuse.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Flulaval Group

subjects received Flulaval™ vaccine according to their priming status and age:

  • 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
  • 9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid.
Biologisk: GSK investigational vaccine GSK1557482A
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects
Aktiv komparator: Fluzone Group

subjects received Fluzone® Sanofi Pasteur's vaccine according to their priming status and age:

  • 3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28
  • 9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid.
Biologisk: Fluzone®
One intramuscular injection for primed subjects, two intramuscular injections for unprimed subjects

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains.
Tidsramme: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Titers were expressed as geometric mean antibody titers (GMTs).
At Day 0 and 28 after last vaccine dose.
Number of Seroconverted Subjects for HI Antibodies Against the Three Strains.
Tidsramme: At Day 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) 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.
At Day 28 after last vaccine dose.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Geometric Mean of Haemagglutination Inhibiting (HI) Antibodies Titers Against the Three Strains, by Age-strata.
Tidsramme: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Titers were expressed as geometric mean antibody titers (GMTs).

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
At Day 0 and 28 after last vaccine dose.
Number of Seroconverted Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
Tidsramme: At Day 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroconversion was defined as the percentage of vaccinees that had either a pre-vaccination (Day 0) 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.

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
At Day 28 after last vaccine dose.
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains.
Tidsramme: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.
At Day 0 and 28 after last vaccine dose.
Number of Seroprotected Subjects for HI Antibodies Titers Against the Three Strains, by Age-strata.
Tidsramme: At Day 0 and 28 after last vaccine dose.

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroprotection rate (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that represents a putative protective level in adults.

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
At Day 0 and 28 after last vaccine dose.
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains.
Tidsramme: At Day 0 and at Day 28 after last vaccine dose

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.

Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.
At Day 0 and at Day 28 after last vaccine dose
Seroconversion Factor (SCF) for HI Antibodies Titers Against the Three Strains, by Age-strata.
Tidsramme: At Day 0 and at Day 28 after last vaccine dose

The three strains assessed were A/Brisbane/59/2007 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Brisbane/60/2008.

Seroconversion factor (SCF) was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination.

Seroconversion factor (SCF) was defined as the geometric mean of the within subjects ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. SCFs were calculated at Day 28 following the complete vaccination regimen.

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
At Day 0 and at Day 28 after last vaccine dose
Number of Subjects Below 5 Years of Age With Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Tidsramme: During a 4-day follow-up period (Days 0-3) after vaccination.

The general symptoms solicited from study subjects younger than 5 years of age were drowsiness, irritability, loss of appetite, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).

Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.

Grade 3 drowsiness, irritability = symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all.

Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.

Related = symptom assessed by the investigator as causally related to the vaccination.
During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects of 5 Years of Age and Above Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Adverse Events (AEs).
Tidsramme: During a 4-day follow-up period (Days 0-3) after vaccination.

The general symptoms solicited from study subjects 5 years of age and older were arthralgia (joint pain), fatigue, headache, muscle aches, shivering, and fever(= axillary temperature equal to or above 38.0 degrees Celsius (°C)).

Any = occurrence of any solicited general symptom regardless of intensity grade or relationship to vaccination.

Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 temperature = axillary temperature ≥ 39.0°C and ≤ 40.0°C.

Related = symptom assessed by the investigator as causaly related to the vaccination.
During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs).
Tidsramme: During a 4-day follow-up period (Days 0-3) after vaccination.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.

Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination.
During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Adverse Events (AEs), by Age-strata.
Tidsramme: During a 4-day follow-up period (Days 0-3) after vaccination.

Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited general symptom regardless of intensity grade.

Grade 3 pain = pain that prevented normal activity. Grade 3 redness, swelling = redness, swelling above 100 millimeter (mm). All solicited local AEs were considered to be causally related to vaccination. Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.
During a 4-day follow-up period (Days 0-3) after vaccination.
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).
Tidsramme: During a 28 day follow-up period (Days 0-27) after vaccination.

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
During a 28 day follow-up period (Days 0-27) after vaccination.
Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs), by Age-strata.
Tidsramme: During a 28 day follow-up period (Days 0-27) after vaccination.

Any adverse event (AE) reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.

Subjects in each group were also stratified in the following age-strata: 3-4 years, 5-8 years and 9-17 years.

Grade 3 = event that prevented normal activities. Related = event assessed by the investigator as causally related to the study vaccination.
During a 28 day follow-up period (Days 0-27) after vaccination.
Number of Subjects Reporting Medically Attended Adverse Events (MAEs).
Tidsramme: During the entire study period (From Day 0 up to Day 180).
For each solicited and unsolicited symptom the subject experiences, the subject/subject's parent(s)/ Legally Acceptable Representative (LAR(s)) was asked if they received medical attention defined as hospitalisation, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason.
During the entire study period (From Day 0 up to Day 180).
Number of Subjects Reporting Serious Adverse Events (SAEs).
Tidsramme: During the entire study period (From Day 0 up to Day 180).
An SAE is defined as any untoward medical occurrence in a patient or clinical investigation subject that: results in death, is lifethreatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
During the entire study period (From Day 0 up to Day 180).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

13. oktober 2009

Primær fullføring (Faktiske)

2. mars 2010

Studiet fullført (Faktiske)

17. juni 2010

Datoer for studieregistrering

Først innsendt

17. september 2009

Først innsendt som oppfylte QC-kriteriene

17. september 2009

Først lagt ut (Anslag)

18. september 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. september 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. august 2018

Sist bekreftet

1. september 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 112999

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

IPD-planbeskrivelse

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokumenter

  1. Studieprotokoll
    Informasjonsidentifikator: 112999
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Datasettspesifikasjon
    Informasjonsidentifikator: 112999
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Klinisk studierapport
    Informasjonsidentifikator: 112999
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datasett for individuell deltaker
    Informasjonsidentifikator: 112999
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Skjema for informert samtykke
    Informasjonsidentifikator: 112999
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistisk analyseplan
    Informasjonsidentifikator: 112999
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotert saksrapportskjema
    Informasjonsidentifikator: 112999
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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