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Prevenar13 Post Market Surveillance

20 décembre 2016 mis à jour par: Pfizer

Post Marketing Surveillance To Observe Safety Of Prevenar 13

It is an observational multi-center study to assess the safety profile of Prevenar13 used among Korean children in the routine clinical setting following a licensure and introduction of the vaccine. This study is designed to fulfill regulatory requirement for any new drug authorized by KFDA.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

non-randomization, non-probability sampling

Type d'étude

Observationnel

Inscription (Réel)

649

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
      • Busan, Corée, République de, 602-739
        • Busan National University Hospital
      • Daegu, Corée, République de, 701847
        • Jaeil Alliance Pediatrics Clinic
      • Daegu, Corée, République de, 702886
        • Teun Teun Pediatric Clinic
      • Daejeon, Corée, République de, 302-799
        • Eulji University Hospital
      • Gyeonggi-do, Corée, République de, 425-707
        • Korea University Ansan Hospital
      • Gyeonggi-do, Corée, République de, 463-712
        • CHA Bundang Medical Center, CHA University
      • Incheon, Corée, République de, 400-711
        • Inha University Hospital
      • Incheon, Corée, République de, 402-852
        • Lee Ha Young Pediatrics
      • Seoul, Corée, République de, 138-736
        • Asan Medical Center
      • Seoul, Corée, République de, 139-711
        • Eulji Medical Center
      • Suyeong-gu, Corée, République de, 613-806
        • JaMo Women's Hospital
      • Ulsan, Corée, République de, 682-714
        • Ulsan University Hospital
    • Gangwon-do
      • Wonju-si, Gangwon-do, Corée, République de, 220-956
        • Choi's Pediatric Clinic
    • Gyeonggi-do
      • Osan, Gyeonggi-do, Corée, République de, 447-804
        • Seoul Children's Hospital
      • Seongnam-si, Gyeonggi-do, Corée, République de, 463-821
        • Bundang Pediatric Clinic
      • Suwon-si, Gyeonggi-do, Corée, République de, 443-471
        • Teun Teun Pediatric Clinic
      • Yangju, Gyeonggi-do, Corée, République de, 482-050
        • Namujungwon Women's Hospital
      • Yongin-si, Gyeonggi-do, Corée, République de, 448-508
        • Yonsei Pediatric Clinic

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 mois à 17 ans (Enfant)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage

La description

Inclusion Criteria:

  • Infants and children aged 6 weeks to 5 years, whose legally authorized representatives of patients agree to provide written informed consent form (data privacy statement).

Exclusion Criteria:

  • Infants and children who are not indicated and/or contraindicated for the Prevenar13 usage will not be included.

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

  • Modèles d'observation: Cas uniquement
  • Perspectives temporelles: Éventuel

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Groupe 1
Biologique: 13-valent pneumococcal vaccine
0.5mL IM (Intramuscular administration) as per recommended schedule
Autres noms:
  • Prévenir 13

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Délai: Within 7 days after Vaccination 1
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Within 7 days after Vaccination 1
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
Délai: Within 7 days after Vaccination 2
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Within 7 days after Vaccination 2
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3
Délai: Within 7 days after Vaccination 3
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Within 7 days after Vaccination 3
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4
Délai: Within 28 days after Vaccination 4
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Within 28 days after Vaccination 4
Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Délai: Within 7 days after Vaccination 1
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 7 days after Vaccination 1
Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
Délai: Within 7 days after Vaccination 2
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 7 days after Vaccination 2
Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3
Délai: Within 7 days after Vaccination 3
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 7 days after Vaccination 3
Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4
Délai: Within 28 days after Vaccination 4
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Within 28 days after Vaccination 4

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Duration of Adverse Events (AEs)
Délai: Baseline up to 28 days after last dose of study vaccination (13 Months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Duration of AE is the total time from onset of adverse event till the event is resolved in participants who had at least 1 AE.
Baseline up to 28 days after last dose of study vaccination (13 Months)
Number of Participants With Adverse Events (AEs) by Severity
Délai: Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event).
Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4
Number of Participants With Outcome in Response to Adverse Events (AEs)
Délai: Baseline up to 28 days after last dose of study vaccination (13 Months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was response to a question answered by those participants who had at least 1 AE: 'Is the adverse event still present?' as 'yes', 'unknown' or 'no-resolved'.
Baseline up to 28 days after last dose of study vaccination (13 Months)
Number of Participants Discontinued Due to Adverse Events
Délai: Baseline up to 28 days after last dose of study vaccination (13 Months)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Baseline up to 28 days after last dose of study vaccination (13 Months)

Collaborateurs et enquêteurs

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

Parrainer

Pfizer

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.

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

1 septembre 2011

Achèvement primaire (Réel)

1 janvier 2016

Achèvement de l'étude (Réel)

1 janvier 2016

Dates d'inscription aux études

Première soumission

30 septembre 2011

Première soumission répondant aux critères de contrôle qualité

9 janvier 2012

Première publication (Estimation)

12 janvier 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

13 février 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 décembre 2016

Dernière vérification

1 décembre 2016

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 6096A1-4029
  • B1851057 (Autre identifiant: Alias Study Number)

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 .

Essais cliniques sur En bonne santé

Essais cliniques sur 13-valent pneumococcal vaccine

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Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

CROs by country

CROs in Slovakia

Conditions

Maladies rares

Interventions en matière de drogue

Compléments alimentaires

Commanditaire / collaborateurs

Emplacements

3
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