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Safety and Immunogenicity of a Booster Dose of GSK Biological's Boostrix-Polio Vaccine

27 april 2018 bijgewerkt door: GlaxoSmithKline

Evaluation of GSK Biological's dTpa-IPV Booster Vaccine in Children and Adolescents, 5 Years After Previous dTpa-IPV Boosting.

Subjects aged 9 to 13 years who participated in the 711866/001 study 5 years ago will be evaluated for immune persistence and will receive a combined dTpa-IPV booster dose that will be evaluated in terms of immunogenicity, safety and reactogenicity.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

415

Fase

  • Fase 4

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
      • Berlin, Duitsland, 12627
        • GSK Investigational Site
      • Berlin, Duitsland, 13507
        • GSK Investigational Site
      • Berlin, Duitsland, 13355
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Ettenheim, Baden-Wuerttemberg, Duitsland, 77955
        • GSK Investigational Site
      • Kehl, Baden-Wuerttemberg, Duitsland, 77694
        • GSK Investigational Site
      • Oberkirch, Baden-Wuerttemberg, Duitsland, 77704
        • GSK Investigational Site
      • Offenburg, Baden-Wuerttemberg, Duitsland, 77654
        • GSK Investigational Site
    • Bayern
      • Cham, Bayern, Duitsland, 93413
        • GSK Investigational Site
      • Kaufering, Bayern, Duitsland, 86916
        • GSK Investigational Site
      • Landshut, Bayern, Duitsland, 84032
        • GSK Investigational Site
      • Muenchen, Bayern, Duitsland, 80939
        • GSK Investigational Site
      • Olching, Bayern, Duitsland, 82140
        • GSK Investigational Site
      • Weilheim, Bayern, Duitsland, 82362
        • GSK Investigational Site
    • Hessen
      • Eschwege, Hessen, Duitsland, 37269
        • GSK Investigational Site
      • Koenigstein, Hessen, Duitsland, 61462
        • GSK Investigational Site
    • Niedersachsen
      • Salzgitter, Niedersachsen, Duitsland, 38226
        • GSK Investigational Site
      • Wolfenbuettel, Niedersachsen, Duitsland, 38302
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Erkrath, Nordrhein-Westfalen, Duitsland, 40699
        • GSK Investigational Site
      • Goch, Nordrhein-Westfalen, Duitsland, 47574
        • GSK Investigational Site
      • Guetersloh, Nordrhein-Westfalen, Duitsland, 33332
        • GSK Investigational Site
      • Heiligenhaus, Nordrhein-Westfalen, Duitsland, 42579
        • GSK Investigational Site
      • Kleve-Materborn, Nordrhein-Westfalen, Duitsland, 47533
        • GSK Investigational Site
      • Krefeld, Nordrhein-Westfalen, Duitsland, 47798
        • GSK Investigational Site
      • Loehne, Nordrhein-Westfalen, Duitsland, 32584
        • GSK Investigational Site
      • Muenster, Nordrhein-Westfalen, Duitsland, 48159
        • GSK Investigational Site
      • Willich, Nordrhein-Westfalen, Duitsland, 47877
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Bad Kreuznach, Rheinland-Pfalz, Duitsland, 55543
        • GSK Investigational Site
      • Frankenthal, Rheinland-Pfalz, Duitsland, 67227
        • GSK Investigational Site
      • Mainz, Rheinland-Pfalz, Duitsland, 55131
        • GSK Investigational Site
      • Trier, Rheinland-Pfalz, Duitsland, 54294
        • GSK Investigational Site
      • Worms, Rheinland-Pfalz, Duitsland, 67547
        • GSK Investigational Site
      • Worms, Rheinland-Pfalz, Duitsland, 67549
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Duitsland, 01307
        • GSK Investigational Site
      • Dresden, Sachsen, Duitsland, 01169
        • GSK Investigational Site
    • Schleswig-Holstein
      • Brunsbuettel, Schleswig-Holstein, Duitsland, 25541
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Duitsland, 24937
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Duitsland, 24939
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Duitsland, 24943
        • 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

9 jaar tot 13 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Subjects who the investigator believes that they or their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female subject who received a booster vaccination with dTpa-IPV or dTpa + IPV in study 711866/001.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Females of childbearing potential at the time of study entry must have a negative pregnancy test prior to administration of the dose of vaccine and are required to be abstinent or to use adequate contraceptive precautions for one month prior to vaccination. Subjects are required to agree to continue such precautions for two months after vaccination.
  • Written informed consent obtained from both parents/ guardians of the subject; assent from the subject himself/herself should also be requested whenever possible.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months prior to the booster dose.
  • Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during study period.
  • 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.
  • Previous booster vaccination against tetanus, diphtheria, pertussis, or poliomyelitis since the booster dose received in study 711866/001.
  • History of diphtheria, tetanus, pertussis, or poliomyelitis diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  • Administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
  • Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
  • Occurrence of any of the following adverse events (AEs) after a previous administration of a DTP vaccine: hypersensitivity reaction to any component of the vaccine, encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine, fever ≥ 40°C within 48 hours of vaccination not due to another identifiable cause, collapse or shock-like state within 48 hours of vaccination
  • Persistent, severe, inconsolable screaming or crying lasting >3 hours occurring within 48 hours of receipt of a previous dose of DTP vaccine convulsions with or without fever, occurring within 3 days of vaccination.
  • Acute disease at the time of enrolment.
  • Pregnant or lactating female.

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: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: BOOSTRIX-POLIO GROUP
Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™-Polio vaccine in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Biologisch: Boostrix-Polio
A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.
Experimenteel: BOOSTRIX + IPV MÉRIEUX GROUP
Healthy male or female subjects aged 9 to 13 years, who were given a single booster dose of Boostrix™ and IPV Mérieux® vaccines in the dTpa-IPV-001 (711866/001) study, additionally received a single booster dose of the Boostrix™-Polio vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Biologisch: Boostrix-Polio
A single booster dose of dTpa-IPV vaccine will be administered to all subjects. IM administration in the deltoid muscle of the non-dominant arm.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects With Any Grade 3 Solicited Local Symptoms
Tijdsspanne: During the 4-day (Days 0-3) follow-up period after booster vaccination
Assessed solicited local symptoms were pain, redness and swelling. Grade 3 Pain: Pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
During the 4-day (Days 0-3) follow-up period after booster vaccination

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Aantal proefpersonen met gevraagde lokale symptomen
Tijdsspanne: Tijdens de follow-upperiode van 4 dagen (dag 0-3) na de boostervaccinatie
De beoordeelde gevraagde lokale symptomen waren pijn, roodheid en zwelling. Elke = optreden van het symptoom ongeacht de graad van intensiteit.
Tijdens de follow-upperiode van 4 dagen (dag 0-3) na de boostervaccinatie
Number of Subjects With Any Solicited General Symptoms
Tijdsspanne: During the 4-day (Days 0-3) follow-up period after booster vaccination
Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
During the 4-day (Days 0-3) follow-up period after booster vaccination
Number of Subjects With Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Toxoids
Tijdsspanne: Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-D and anti-T antibody concnetration greater than or equal to (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL have been assessed by enzyme-linked immunosorbent assay (ELISA). Pre-vaccination sera with ELISA concentrations < 0.1 IU/mL were tested for neutralising antibodies using a Vero-cell neutralisation assay with a 0.016 IU/mL cut-off.
Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-D and Anti-T Antibody Concentrations
Tijdsspanne: Prior to (Month 0) and one month after (Month 1) booster vaccination
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Tijdsspanne: Prior to (Month 0) and one month after (Month 1) booster vaccination
A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA unit per milliliter (EL.U/ml).
Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Tijdsspanne: Prior to (Month 0) and one month after (Month 1) booster vaccination
Antibodies concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
Tijdsspanne: Prior to (Month 0) and one month after (Month 1) booster vaccination
A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ the value of 8.
Prior to (Month 0) and one month after (Month 1) booster vaccination
Anti-Polio 1, 2 and 3 Antibody Titers
Tijdsspanne: Prior to (Month 0) and one month after (Month 1) booster vaccination
Antibody titers were presented as geometric mean titers (GMTs).
Prior to (Month 0) and one month after (Month 1) booster vaccination
Number of Subjects With Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Tijdsspanne: One month after booster vaccination (At Month 1)
Booster vaccine response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL) or at least 2-fold increase of pre-vaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations < 5 EL.U/mL).
One month after booster vaccination (At Month 1)
Number of Subjects With Unsolicited Adverse Events (AEs)
Tijdsspanne: During the 31-day (Days 0-30) follow-up period after booster vaccination
AEs results are presented for all subjects. An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
During the 31-day (Days 0-30) follow-up period after booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Tijdsspanne: During the entire booster period (Month 0 to Month 1)
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
During the entire booster period (Month 0 to Month 1)

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)

1 februari 2008

Primaire voltooiing (Werkelijk)

8 juli 2008

Studie voltooiing (Werkelijk)

8 juli 2008

Studieregistratiedata

Eerst ingediend

6 maart 2008

Eerst ingediend dat voldeed aan de QC-criteria

6 maart 2008

Eerst geplaatst (Schatting)

13 maart 2008

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 juni 2018

Laatste update ingediend die voldeed aan QC-criteria

27 april 2018

Laatst geverifieerd

1 april 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 110947

Plan Individuele Deelnemersgegevens (IPD)

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

JA

Beschrijving IPD-plan

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

Bestudeer gegevens/documenten

  1. Specificatie gegevensset
    Informatie-ID: 110947
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinisch onderzoeksrapport
    Informatie-ID: 110947
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulier geïnformeerde toestemming
    Informatie-ID: 110947
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  4. Gegevensset individuele deelnemers
    Informatie-ID: 110947
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  5. Leerprotocool
    Informatie-ID: 110947
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistisch analyseplan
    Informatie-ID: 110947
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  7. Geannoteerd casusrapportformulier
    Informatie-ID: 110947
    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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