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Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM

9. august 2018 oppdatert av: GlaxoSmithKline

Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine FluarixTM in Adolescents Previously Vaccinated With GSK Biologicals' H1N1 Vaccine PandemrixTM

This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been vaccinated with one dose of PandemrixTM at the age of 10-17 years.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

77

Fase

  • Fase 4

Kontakter og plasseringer

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

Studiesteder

  • Finland
      • Tampere, Finland, 33100
        • 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

10 år til 18 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects having previously been immunized with only one single dose of Pandemrix at the age of 10-17 years inclusive.
  • Subjects having received Pandemrix at least six months prior to study enrolment.
  • Subjects who the investigator believes that subject and/or parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
  • Written informed consent obtained from the subject/ the parent(s)/LAR(s) of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects or Parent(s)/LAR(s) with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device

Exclusion Criteria:

  • Active participation in other clinical trials.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
  • Acute disease and/or fever at the time of enrolment:
  • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
  • Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • History of seizures or progressive neurological disease.
  • Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
  • If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
  • Child in care.

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: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Fluarix Group
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Biologisk: FluarixTM
One Intramuscular injection
Aktiv komparator: Havrix Group
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Biologisk: HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)
Two Intramuscular injections

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Tidsramme: At Day 0 and Day 28

Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).

Day 28 data were presented only for the Fluarix Group.

Titres were expressed as geometric mean antibody titre.
At Day 0 and Day 28
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Tidsramme: At Day 0 and Day 28

Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).

Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.

Day 28 data was presented only for the Fluarix Group.
At Day 0 and Day 28
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Tidsramme: At Day 28

Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).

A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.

Day 28 data were presented for the Fluarix Group only.
At Day 28
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Tidsramme: At Day 0 and Day 28

Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).

A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.

Day 28 data were presented for the Fluarix Group only.
At Day 0 and Day 28
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Tidsramme: At Day 28

Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).

MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.

Day 28 data were presented for the Fluarix Group only.
At Day 28

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Day 0 and Day 28

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

Day 28 data were presented for the Fluarix Group only.

Titres were expressed as geometric mean antibody titres (GMTs).
At Day 0 and Day 28
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Day 0 and at Month 6

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.

Titres were expressed as geometric mean antibody titres (GMTs).
At Day 0 and at Month 6
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Day 0 and Day 28

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.

Day 28 data were presented for the Fluarix Group only.
At Day 0 and Day 28
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Day 0 and at Month 6

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

Seropositivity was assessed for subjects with an antibody titre assay cut-off equal to or above 1:10.

Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
At Day 0 and at Month 6
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Day 28

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.

Day 28 data were presented for the Fluarix Group only.
At Day 28
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Month 6

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.

Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
At Month 6
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Day 0 and Day 28

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.

Day 28 data were presented for the Fluarix Group only.
At Day 0 and Day 28
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Day 0 and Month 6

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.

Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
At Day 0 and Month 6
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Day 28

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.

Day 28 data were presented for the Fluarix Group only.
At Day 28
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Month 6

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.

MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.

Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
At Month 6
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Day 0 and at Day 28

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09(H3N2) and B/Brisbane/60/2008.

Day 28 data were presented for the Fluarix Group only.

Titres were expressed as geometric mean antibody titres (GMTs).
At Day 0 and at Day 28
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Day 0 and at Month 6

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.

Titres were expressed as geometric mean antibody titres (GMTs).
At Day 0 and at Month 6
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Day 28

A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.

Day 28 data were presented for the Fluarix Group only.
At Day 28
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Tidsramme: At Month 6

A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.

Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.

At Month 6, only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
At Month 6
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Tidsramme: Within 7 days (Day 0 - Day 6) after vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimetres.
Within 7 days (Day 0 - Day 6) after vaccination
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Tidsramme: Within 7 days (Day 0 - Day 6) after vaccination

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).

Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0 degrees Celsius.
Within 7 days (Day 0 - Day 6) after vaccination
Number of Days With Any Solicited Local Symptoms.
Tidsramme: Within 7 days (Day 0 - Day 6) after vaccination

Solicited local symptoms assessed were pain, redness and swelling.

Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Within 7 days (Day 0 - Day 6) after vaccination
Number of Days With Grade 3 Solicited Local Symptoms.
Tidsramme: Within 7 days (Day 0 - Day 6) after vaccination

Solicited local symptoms assessed were pain and swelling.

Grade 3 redness/swelling = redness/swelling above 50 millimetres.

Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Within 7 days (Day 0 - Day 6) after vaccination
Number of Days With Any Solicited General Symptoms.
Tidsramme: Within 7 days (Day 0 - Day 6) after vaccination

Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).

Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Within 7 days (Day 0 - Day 6) after vaccination
Number of Days With Grade 3 Solicited General Symptoms.
Tidsramme: Within 7 days (Day 0 - Day 6) after vaccination

Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and myalgia.

Grade 3 symptom = general symptom that prevented normal activity.

Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Within 7 days (Day 0 - Day 6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Tidsramme: Within 28 days (Day 0 - Day 27) after vaccination

An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.

Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
Within 28 days (Day 0 - Day 27) after vaccination
Number of Subjects Reporting Medically-attended Events (MAEs).
Tidsramme: Within the 28-day (Days 0-27) post-vaccination period
For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Within the 28-day (Days 0-27) post-vaccination period
Number of Subjects Reporting Medically-attended Events (MAEs).
Tidsramme: During the entire study period (Up to Month 6)
For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
During the entire study period (Up to Month 6)
Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).
Tidsramme: During the entire study period (Up to Month 6)
Potential Immune-Mediated Diseases (pIMDs) or Adverse events of specific interest (AESI), are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
During the entire study period (Up to Month 6)
Number of Subjects Reporting Adverse Events of Special Interest.
Tidsramme: During the entire study period (Up to Month 6)
Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis.
During the entire study period (Up to Month 6)
Number of Subjects Reporting Serious Adverse Events (SAEs).
Tidsramme: Within the 28-day (Days 0-27) post-vaccination period
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Within the 28-day (Days 0-27) post-vaccination period
Number of Subjects Reporting Serious Adverse Events (SAEs).
Tidsramme: During the entire study period (Up to Month 6)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
During the entire study period (Up to Month 6)

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

4. oktober 2010

Primær fullføring (Faktiske)

7. juli 2011

Studiet fullført (Faktiske)

7. juli 2011

Datoer for studieregistrering

Først innsendt

26. august 2010

Først innsendt som oppfylte QC-kriteriene

26. august 2010

Først lagt ut (Anslag)

27. august 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. september 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. august 2018

Sist bekreftet

1. august 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 114452

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: 114452
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinisk studierapport
    Informasjonsidentifikator: 114452
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistisk analyseplan
    Informasjonsidentifikator: 114452
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Skjema for informert samtykke
    Informasjonsidentifikator: 114452
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Datasett for individuell deltaker
    Informasjonsidentifikator: 114452
    Informasjonskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Datasettspesifikasjon
    Informasjonsidentifikator: 114452
    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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