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

27 aprile 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

415

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 9 anni a 13 anni (Bambino)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Biologico: 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.
Sperimentale: 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.
Biologico: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects With Any Grade 3 Solicited Local Symptoms
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Numero di soggetti con qualsiasi sintomo locale sollecitato
Lasso di tempo: Durante il periodo di follow-up di 4 giorni (giorni 0-3) dopo la vaccinazione di richiamo
I sintomi locali sollecitati valutati erano dolore, arrossamento e gonfiore. Qualsiasi = occorrenza del sintomo indipendentemente dal grado di intensità.
Durante il periodo di follow-up di 4 giorni (giorni 0-3) dopo la vaccinazione di richiamo
Number of Subjects With Any Solicited General Symptoms
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 febbraio 2008

Completamento primario (Effettivo)

8 luglio 2008

Completamento dello studio (Effettivo)

8 luglio 2008

Date di iscrizione allo studio

Primo inviato

6 marzo 2008

Primo inviato che soddisfa i criteri di controllo qualità

6 marzo 2008

Primo Inserito (Stima)

13 marzo 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 giugno 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

27 aprile 2018

Ultimo verificato

1 aprile 2017

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 110947

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Dati/documenti di studio

  1. Specifica del set di dati
    Identificatore informazioni: 110947
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Rapporto di studio clinico
    Identificatore informazioni: 110947
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Modulo di consenso informato
    Identificatore informazioni: 110947
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Set di dati del singolo partecipante
    Identificatore informazioni: 110947
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protocollo di studio
    Identificatore informazioni: 110947
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Piano di analisi statistica
    Identificatore informazioni: 110947
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Modulo di segnalazione del caso annotato
    Identificatore informazioni: 110947
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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