Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' IPV Vaccine (PoliorixTM) in Toddlers
20 décembre 2017 mis à jour par: GlaxoSmithKline
An Open-label Study to Assess the Safety and Reactogenicity of GlaxoSmithKline Biologicals' Inactivated Poliomyelitis Vaccine Poliorix Administered as a Booster Dose at 18-24 Months of Age in Healthy Toddlers in China.
The study will evaluate the safety and reactogenicity of PoliorixTM given as a single booster dose to Chinese children at 18-24 months of age.
Aperçu de l'étude
Type d'étude
Interventionnel
Inscription (Réel)
26
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
-
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Guangxi
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Wuzhou, Guangxi, Chine, 543002
- GSK Investigational Site
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-
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 2 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- A male or female toddler between, and including, 18 and 24 months of age at the time of the booster vaccination.
- Subjects who received three doses of OPV as primary vaccination in the first year of life as per Chinese recommendations.
- Subjects who the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- Written informed consent obtained from the parent or guardian of the subject.
- 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 other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccination
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of DTP and/or Hib vaccine(s).
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster vaccination, or planned administration 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
- Previous booster vaccination against poliomyelitis since the end of the primary vaccination series.
- History of poliomyelitis disease.
- History of seizures or progressive neurological disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Major congenital defects or serious chronic illness.
The following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
• Current febrile illness or axillary temperature > 37.0 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
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: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: POLIORIX GROUP
Healthy male or female subjects between, and including, 18 and 24 months of age, received a single booster dose of Poliorix™ vaccine that was administrated into the upper right thigh by intramuscular injection (IM).
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Single dose, intramuscular administration.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Délai: During the 4-day (Days 0-3) post-vaccination period
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Assessed solicited local symptoms were pain, redness and swelling.
Any = all reports of the specified symptom irrespective of intensity grade.
Grade 3 pain = cried when limb was moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling spreading beyond 30 millimeters (mm) of injection site.
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During the 4-day (Days 0-3) post-vaccination period
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Délai: During the 4-day (Days 0-3) post-vaccination period
|
Assessed solicited general symptoms were temperature [defined as axillary temperature equal to or above (≥) 37.1 degrees Celsius (°C)], drowsiness, irritability and loss of appetite.
Any = all reports of the specified symptom irrespective of intensity grade and relationship to vaccination.
Grade 3 drowsiness= drowsiness that prevented normal activity.
Grade 3 irritability= crying that could not be comforted/ prevented normal activity.
Grade 3 loss of appetite= subject did not eat at all.
Grade 3 fever = fever above (>) 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 4-day (Days 0-3) post-vaccination period
|
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Délai: During the 31-day (Days 0-30) post-vaccination period
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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.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
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During the 31-day (Days 0-30) post-vaccination period
|
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Number of Subjects With Serious Adverse Events (SAEs)
Délai: During the entire study period (from Day 0 to Month 1)
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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During the entire study period (from Day 0 to Month 1)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
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.
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 juin 2009
Achèvement primaire (Réel)
3 août 2009
Achèvement de l'étude (Réel)
3 août 2009
Dates d'inscription aux études
Première soumission
12 juin 2009
Première soumission répondant aux critères de contrôle qualité
12 juin 2009
Première publication (Estimation)
15 juin 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
19 janvier 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
20 décembre 2017
Dernière vérification
1 mai 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 112683
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
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Rapport d'étude clinique
Identifiant des informations: 112683Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Ensemble de données de participant individuel
Identifiant des informations: 112683Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Formulaire de consentement éclairé
Identifiant des informations: 112683Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Plan d'analyse statistique
Identifiant des informations: 112683Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
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Protocole d'étude
Identifiant des informations: 112683Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
-
Spécification du jeu de données
Identifiant des informations: 112683Commentaires d'informations: For additional information about this study please refer to the GSK Clinical Study Register
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
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 .