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Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine

21 août 2018 mis à jour par: GlaxoSmithKline

Booster Vaccination With Pneumococcal Vaccine GSK1024850A or Prevenar™ Co-administered With Hiberix™ in Children Primed With the Same Vaccines

The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

450

Phase

  • Phase 3

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

  • Corée, République de
      • Ansan, Corée, République de, 425-707
        • GSK Investigational Site
      • Bucheon-Si, GyeongGi-do,, Corée, République de, 420-767
        • GSK Investigational Site
      • Daejeon, Corée, République de, 301-723
        • GSK Investigational Site
      • GyeongSangNam-do, Corée, République de, 641-560
        • GSK Investigational Site
      • Gyeonggi-do, Corée, République de, 411-706
        • GSK Investigational Site
      • Iksan, Corée, République de, 570-711
        • GSK Investigational Site
      • Jeju City, Corée, République de, 690-121
        • GSK Investigational Site
      • Jeonju Jeonbuk, Corée, République de, 561-712
        • GSK Investigational Site
      • Pusan, Corée, République de, 602-739
        • GSK Investigational Site
      • Seoul, Corée, République de, 150-719
        • GSK Investigational Site
      • Seoul, Corée, République de, 130-702
        • GSK Investigational Site
      • Seoul, Corée, République de, 158-710
        • GSK Investigational Site
      • Suwon City, Gyeonggi-do, Corée, République de, 442-723
        • GSK Investigational Site
      • Wonju-si Kangwon-do, Corée, République de, 220-701
        • 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

1 an à 1 an (Enfant)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • A male or female between, and including, 12-18 months of age at the time of booster vaccination.
  • Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
  • Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
  • Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the vaccination, or planned use during the 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 (pharmaceutical product or device).
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
  • Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
  • Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
  • Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
  • Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
  • Acute disease at the time of enrolment.

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: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Synflorix Group
Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Biologique: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)
Intramuscular injection, administered as a single dose
Autres noms:
  • Pneumococcal vaccine GSK1024850A
Biologique: GSK Biologicals' Hiberix™
Intramuscular injection, administered as a single dose
Autres noms:
  • Hib
Comparateur actif: Prevenar Group
Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Biologique: GSK Biologicals' Hiberix™
Intramuscular injection, administered as a single dose
Autres noms:
  • Hib
Biologique: Wyeth-Lederle's Prevenar™
Intramuscular injection, administered as a single dose

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Subjects Reporting Grade 3 Adverse Events
Délai: Within 31 days (Day 0 - Day 30) after booster vaccination.
Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.
Within 31 days (Day 0 - Day 30) after booster vaccination.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Number of Subjects Reporting Solicited Symptoms
Délai: Within 4 days (Days 0 to 3) after booster vaccination
Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.
Within 4 days (Days 0 to 3) after booster vaccination
Number of Subjects Reporting Unsolicited Adverse Events
Délai: Within 31 days (Days 0 to 30) after booster 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 the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Within 31 days (Days 0 to 30) after booster vaccination
Number of Subjects Reporting Serious Adverse Events
Délai: After booster vaccination up to study end (Month 0 to Month 1)
Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
After booster vaccination up to study end (Month 0 to Month 1)
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes
Délai: One month after booster vaccination (Month 1)

Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL).

Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
One month after booster vaccination (Month 1)
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes
Délai: One month after booster vaccination (Month 1)

Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.

Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
One month after booster vaccination (Month 1)
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Délai: One month after booster vaccination (Month 1)
Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.
One month after booster vaccination (Month 1)
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A
Délai: One month after booster vaccination (Month 1)
Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
One month after booster vaccination (Month 1)
Concentration of Antibodies Against Protein D (PD)
Délai: One month after booster vaccination (Month 1)
Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).
One month after booster vaccination (Month 1)
Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)
Délai: One month after booster vaccination (Month 1)
Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.
One month after booster vaccination (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

11 juin 2009

Achèvement primaire (Réel)

11 janvier 2010

Achèvement de l'étude (Réel)

11 janvier 2010

Dates d'inscription aux études

Première soumission

28 mai 2009

Première soumission répondant aux critères de contrôle qualité

28 mai 2009

Première publication (Estimation)

1 juin 2009

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

20 septembre 2018

Dernière mise à jour soumise répondant aux critères de contrôle qualité

21 août 2018

Dernière vérification

1 octobre 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 112933

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. Formulaire de consentement éclairé
    Identifiant des informations: 112933
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  2. Spécification du jeu de données
    Identifiant des informations: 112933
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  3. Ensemble de données de participant individuel
    Identifiant des informations: 112933
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  4. Formulaire de rapport de cas annoté
    Identifiant des informations: 112933
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  5. Protocole d'étude
    Identifiant des informations: 112933
    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: 112933
    Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
  7. Rapport d'étude clinique
    Identifiant des informations: 112933
    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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