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

27 avril 2018 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

415

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

9 ans à 13 ans (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Biologique: 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.
Expérimental: 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.
Biologique: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Subjects With Any Grade 3 Solicited Local Symptoms
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Nombre de sujets présentant des symptômes locaux sollicités
Délai: Pendant la période de suivi de 4 jours (jours 0 à 3) après la vaccination de rappel
Les symptômes locaux sollicités évalués étaient la douleur, la rougeur et l'enflure. Tout = apparition du symptôme quel que soit le degré d'intensité.
Pendant la période de suivi de 4 jours (jours 0 à 3) après la vaccination de rappel
Number of Subjects With Any Solicited General Symptoms
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

GlaxoSmithKline

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 février 2008

Achèvement primaire (Réel)

8 juillet 2008

Achèvement de l'étude (Réel)

8 juillet 2008

Dates d'inscription aux études

Première soumission

6 mars 2008

Première soumission répondant aux critères de contrôle qualité

6 mars 2008

Première publication (Estimation)

13 mars 2008

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

6 juin 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

27 avril 2018

Dernière vérification

1 avril 2017

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 110947

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Données/documents d'étude

  1. Spécification du jeu de données
    Identifiant des informations: 110947
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  2. Rapport d'étude clinique
    Identifiant des informations: 110947
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulaire de consentement éclairé
    Identifiant des informations: 110947
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  4. Ensemble de données de participant individuel
    Identifiant des informations: 110947
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protocole d'étude
    Identifiant des informations: 110947
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  6. Plan d'analyse statistique
    Identifiant des informations: 110947
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  7. Formulaire de rapport de cas annoté
    Identifiant des informations: 110947
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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