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Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children

11 juni 2019 bijgewerkt door: GlaxoSmithKline

Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years

The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This Protocol Posting has been updated following Protocol amendment 1, October 2009. The impacted section are the study design section, the outcomes measures section and the intervention section.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

245

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Duitsland
    • Baden-Wuerttemberg
      • Kehl, Baden-Wuerttemberg, Duitsland, 77694
        • GSK Investigational Site
      • Schwaebisch-Hall, Baden-Wuerttemberg, Duitsland, 74523
        • GSK Investigational Site
      • Stuttgart, Baden-Wuerttemberg, Duitsland, 70469
        • GSK Investigational Site
    • Bayern
      • Bindlach, Bayern, Duitsland, 95463
        • GSK Investigational Site
      • Muenchen, Bayern, Duitsland, 81241
        • GSK Investigational Site
      • Noerdlingen, Bayern, Duitsland, 86720
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Frankenthal, Rheinland-Pfalz, Duitsland, 67227
        • GSK Investigational Site
      • Worms, Rheinland-Pfalz, Duitsland, 67547
        • GSK Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

3 jaar tot 17 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
  • Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
  • Healthy children as established by medical history and clinical examination when entering into the study.
  • Parent/LAR 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:

  • 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.
  • Clinically or virologically confirmed influenza infection within six months preceding the study start.
  • 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
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
  • Previous administration of any H1N1 A/California-like vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • 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.
  • 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.
  • Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
  • Child in Care.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Group A
Subjects receiving alternative dose of GSK23440272A vaccine
Biologisch: GSK investigational vaccine GSK2340272A
Three intramuscular injections

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Tijdsspanne: At Day 0, Day 21 and Day 42
Antibody titers were expressed as Geometric mean titers (GMTs).
At Day 0, Day 21 and Day 42
Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Tijdsspanne: At Day 42
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination 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. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
At Day 42
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Tijdsspanne: At Day 42
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
At Day 42
HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
Tijdsspanne: At Day 42
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
At Day 42

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Tijdsspanne: At Month 6
Antibody titers were expressed as geometric mean titers (GMTs)
At Month 6
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against the Flu A/California/7/2009 (H1N1) Vaccine Strain
Tijdsspanne: At Month 12
Antibody titers were expressed as geometric mean titers (GMTs)
At Month 12
Number of Seroconverted Subjects for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Tijdsspanne: At Month 6
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination 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. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
At Month 6
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Tijdsspanne: At Month 6
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
At Month 6
Number of Subjects Who Were Seroprotected for HI Antibodies Against the Flu A/California/7/2009 (H1N1) Virus Strain
Tijdsspanne: At Month 12
A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to (≥) 1:40, that usually is accepted as indicating protection. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the post-vaccination time point estimate for SPR the point estimate for SPR was greater than (>) 70% in children aged 3 to 17 years.
At Month 12
HI Antibody Geometric Mean Fold Rise (GMFR) Against the Flu A/California/7/2009 (H1N1) Virus Strain
Tijdsspanne: At Month 6
GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The CHMP criterion was fulfilled if the point estimate for GMFR was greater than (>) 2.5 in children aged 3 to 17 years
At Month 6
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
Tijdsspanne: At Day 0, Day 21, Day 42 and Month 6
Antibody titers were expressed as Geometric mean titers (GMTs).
At Day 0, Day 21, Day 42 and Month 6
Humoral Immune Response in Terms of Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Vaccine Strain
Tijdsspanne: At Month 12
Antibody titers were expressed as Geometric mean titers (GMTs).
At Month 12
Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
Tijdsspanne: At Day 21 and Day 42
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination 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. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
At Day 21 and Day 42
Number of Seroconverted Subjects for Neutralising Antibodies Against the Flu A/Netherlands/602/2009 (H1N1) Virus Strain
Tijdsspanne: At Month 6
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination 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. The Committee for Medicinal Products for Human Use (CHMP) criterion was fulfilled if the point estimate for SCR was greater than (>) 40% in children aged 3 to 17 years.
At Month 6
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Tijdsspanne: During the 7-day (Days 0-6) post-vaccination period
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as significant pain at rest that prevented normal everyday activities as assessed by inability to attend/do work or school or cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was greater than 50 millimeters (mm) i.e. > 50mm.
During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Tijdsspanne: During the 7-day (Days 0-6) post-vaccination period
Solicited general symptoms assessed were arthralgia, diarrhoea, drowsiness, fatigue, gastro-intestinal symptoms, headache, irritability, loss of appetite, myalgia, shivering, sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C.
During the 7-day (Days 0-6) post-vaccination period
Number of Subjects Reporting Any Medically Attended Adverse Events (MAEs)
Tijdsspanne: During the entire study period (Day 0 to Month 12)
MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination.
During the entire study period (Day 0 to Month 12)
Number of Subjects Reporting Any Adverse Events of Specific Interest (AESI)/Potential Immune-mediated Diseases (pIMDs)
Tijdsspanne: During the entire study period (Day 0 to Month 12)
Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune etiology. "Any pIMD" was defined as at least one pIMD experienced by the study subject.
During the entire study period (Day 0 to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Tijdsspanne: Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination
An unsolicited AE was defined as any AE (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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Within the 84-day after the first vaccination or from 63-day follow-up period after the second vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Tijdsspanne: During the entire study period (Day 0 to Month 12)
A serious adverse event was any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
During the entire study period (Day 0 to Month 12)
Number of Subjects With Normal and Abnormal Haematological and Biochemistry Parameters With Respect to Alanine Aminotransferase (ALAT), Aspartate Aminotransferase (ASAT), Total Bilirubin, Bilirubin Conjugated/ Direct,Creatine and Blood Urea Nitrogen(BUN)
Tijdsspanne: At Day 0, Day 21, Day 42 and Month 6 (M6)
Subjects were categorized by age and according to their results at pre-vaccination (Day 0), Day 21, Day 42 and Month 6 which were below, within and above the normal ranges or unknown as measured by validated assay according to international standards.
At Day 0, Day 21, Day 42 and Month 6 (M6)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

GlaxoSmithKline

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 september 2009

Primaire voltooiing (Werkelijk)

22 november 2010

Studie voltooiing (Werkelijk)

22 november 2010

Studieregistratiedata

Eerst ingediend

3 september 2009

Eerst ingediend dat voldeed aan de QC-criteria

4 september 2009

Eerst geplaatst (Schatting)

7 september 2009

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 juni 2019

Laatste update ingediend die voldeed aan QC-criteria

11 juni 2019

Laatst geverifieerd

1 juni 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 113638
  • 2009-015011-41 (EudraCT-nummer)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

Ja

Beschrijving IPD-plan

IPD for this study will be made available via the Clinical Study Data Request site.

IPD-tijdsbestek voor delen

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD-toegangscriteria voor delen

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

IPD delen Ondersteunend informatietype

  • Leerprotocool
  • Statistisch Analyse Plan (SAP)
  • Formulier voor geïnformeerde toestemming (ICF)
  • Klinisch onderzoeksrapport (CSR)

Bestudeer gegevens/documenten

  1. Formulier geïnformeerde toestemming
    Informatie-ID: 113638
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinisch onderzoeksrapport
    Informatie-ID: 113638
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  3. Leerprotocool
    Informatie-ID: 113638
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  4. Gegevensset individuele deelnemers
    Informatie-ID: 113638
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  5. Specificatie gegevensset
    Informatie-ID: 113638
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistisch analyseplan
    Informatie-ID: 113638
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  7. Geannoteerd casusrapportformulier
    Informatie-ID: 113638
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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Klinische onderzoeken op GSK investigational vaccine GSK2340272A

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