Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos
5 décembre 2016 mis à jour par: Pfizer
A Non-interventional Study Of The Safety Of Pneumococcal 13-valent Conjugate Vaccine (Prevenar 13) In The Philippines: A Post Marketing Surveillance Study
Prevenar 13 is safe for administration to Filipinos.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Filipino patients prescribed and administered with the vaccine will be monitored for safety Patients prescribed with the vaccine who provides consent for inclusion to the study will be observed.
Type d'étude
Observationnel
Inscription (Réel)
3006
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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-
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Angeles City, Philippines
- Private Clinic
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Antipolo City, Philippines
- Private Clinic
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Bacolod CIty, Philippines
- Medical Arts Building
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Bacolod City, Philippines, 6100
- Dr. Pablo O. Torre Memorial Medical Center
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Bacolod City, Philippines
- Medical Plaza
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Bacolod City, Philippines
- Private Clinic
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Bacolod City, Philippines
- Riverside Medical Center
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Bacolod City, Philippines
- Room 302 Medical Arts Building
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Bacolod City, Philippines
- Room 311 Riverside Medical Arts Building
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Bacolod City, Philippines
- Villanueva Laboratory and Clinics
-
Batangas, Philippines
- Private Clinic
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Batangas, Philippines
- MCA Bauanan Children's Clinic
-
Batangas City, Philippines
- Private Clinic
-
Binondo, Manila, Philippines
- Metropolitan Medical Center
-
Bocaue, Philippines
- Private Clinic
-
Bulacan, Philippines
- Private Clinic
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Bulacan, Philippines
- 417
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Bulacan, Philippines
- Clinica Tapia
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Bulacan, Philippines
- Pediatric Doctor's Clinic
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Bulacan, Philippines
- St Vincent's Wellness Clinic
-
Cagayan De Oro City, Philippines
- Room 11
-
Caloocan City, Philippines
- Centralle Medical Diagnostics and Polyclinic
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Caloocan City, Philippines
- Private Clinic
-
Candelaria City, Philippines
- Private Clinic
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Capiz City, Philippines
- Blk 19 Lot 11
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Cavite, Philippines
- Private Clinic
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Cebu, Philippines
- Chong Hua Hospital
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Cebu, Philippines, 6000
- Cebu Doctor University Hospital
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Cebu, Philippines, 6000
- Chong Hua Hospital
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Cebu City, Philippines
- Private Clinic
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Cebu City, Philippines
- Chong Hua Hospital
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Cebu City, Philippines
- Basement
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Cebu City, Philippines
- Care and Cure Hub
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Cebu City, Philippines
- Cebu Doctors University Hopsital
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Cebu City, Philippines
- PPG, Manila, Philippines
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Cebu City, Philippines
- Rm4A, Medical Arts Building
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Cebu City, Philippines
- Room 302-A
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Cebu City, Philippines
- Room 413 Medical Arts Building 2
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Cebu City, Philippines
- Room 419 SPC Medical Specialty Center
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Cebu City, Philippines
- Room 505A Chong Hua Medical Arts Building
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Dagupan City, Philippines
- Private Clinic
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Davao City, Philippines
- Private Clinic
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Davao City, Philippines
- Community Health and Development Cooperative Hospital
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Davao City, Philippines
- Health Science and Wellness Center
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Davao City, Philippines
- Jesusa Complex
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Davao City, Philippines
- San Pedro Hospital Inc.
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Davao City, Philippines
- San Pedro Hospital
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Dipolog City, Philippines
- Private Clinic
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Dumaguete City, Philippines
- Private Clinic
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Dumaguete City, Philippines
- Room 117 Medical Arts Building
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Iligan City, Philippines
- Iligan Specialist Clinic
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Iloilo City, Philippines
- Private Clinic
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Koronadal City, Philippines
- Private Clinic
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Laguna, Philippines
- Private Clinic
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Las Pinas City, Philippines
- Las Piñas Doctors Hospital
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Legaspi City, Philippines
- Private Clinic
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Lipa City, Philippines
- Private Clinic
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Lucena City, Philippines
- Lucena United Doctors Hospital
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Lucena City, Philippines
- Private Clinic
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Makati City, Philippines
- Private Clinic
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Malabon, Philippines
- Tumbicon Polycare
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Malabon City, Philippines
- Archangel Raphael Pediatric Clinic
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Malabon City, Philippines
- Children's Clinic
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Malabon City, Philippines
- Malabon Medical Clinic
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Malolos City, Philippines
- Private Clinic
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Mandaluyong City, Philippines
- Private Clinic
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Manila, Philippines
- Private Clinic
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Manila, Philippines, 1000
- Metropolitan Medical Center
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Manila, Philippines
- 1952
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Manila, Philippines
- Children's Clinic
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Manila, Philippines
- Chinese General Hospital
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Manila, Philippines
- Rm714B
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Manila, Philippines
- Room 210, Metropolitan Medical Center
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Manila, Philippines
- Room 706
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Marikina City, Philippines
- Private Clinic
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Marikina City, Philippines, 1801
- Marikina Valley Medical Center
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Marikina City, Philippines
- Centro Medical and Laboratory Clinic
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Marikina City, Philippines
- Garcia General Hospital
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Marikina City, Philippines
- Room 605
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Negors Occidental, Philippines
- Private Clinic
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Negros Occidental, Philippines
- Private Clinic
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Pampanga, Philippines
- Mabalacat Child Care Clinic
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Pangasinan, Philippines
- Private Clinic
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Paranaque, Philippines
- Maglana Villamor Clinic
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Paranaque, Philippines
- Paranaque Doctors Hospital
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Pasig, Philippines
- Private Clinic
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Pasig City, Philippines
- Private Clinic
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Quezon, Philippines
- Private Clinic
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Quezon, Philippines
- Emil-Joanna General Hospital
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Quezon CIty, Philippines
- Madrid Polyclinic
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Quezon City, Philippines, 1100
- Philippine Heart Center
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Quezon City, Philippines
- Private Clinic
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Quezon City, Philippines
- Friendly Care Clinic
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Quezon City, Philippines
- Maternity and Children's Clinic
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Quezon City, Philippines
- Medical Specialist Clinic
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Quezon City, Philippines
- Natividad Children's Clinic
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Quezon City, Philippines
- Philippine Heart Center
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Quezon City, Philippines
- Room 11
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Quezon City, Philippines
- World Citi Medical Center
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Rizal, Philippines
- Children's Clinic
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Rizal, Philippines
- Private Clinic
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San Pablo City, Philippines
- Community General Hospital
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San Pablo City, Philippines
- Private Clinic
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South Luzon, Philippines
- Private Clinic
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Sta. Cruz, Manila, Philippines
- Chinese General Hospital and Medical Center
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Tagbilaran City, Philippines
- Private Clinic
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Tarlac City, Philippines
- Private Clinic
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Urdaneta City, Philippines
- Private Clinic
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Valenzuela City, Philippines
- Private Clinic
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Zamboanga City, Philippines
- Private Clinic
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Zamboanga City, Philippines
- Room 331
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Batangas
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Lipa City, Batangas, Philippines
- Private Clinic
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Bohol
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Tagbilaran City, Bohol, Philippines
- Private Clinic
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Bulacan
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Malolos, Bulacan, Philippines
- Private Clinic
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Negros Occidental
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Bacolod City, Negros Occidental, Philippines
- Room 220 The Doctor's Hospital, Inc.
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San Carlos City, Negros Occidental, Philippines
- Private Clinic
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San Carlos City, Negros Occidental, Philippines
- San Carlos Doctor's Hospital
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Victorias City, Negros Occidental, Philippines
- Victorias Commercial Center
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Pangasinan
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Dagupan City, Pangasinan, Philippines
- Private Clinic
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Mangaldan, Pangasinan, Philippines
- Private Clinic
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Pozorrubio, Pangasinan, Philippines
- Private Clinic
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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 mois et plus (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Filipino patients prescribed with the vaccine
La description
Inclusion Criteria:
Patients prescribed with the vaccine
Exclusion Criteria:
Patients with hypersensitivity to the vaccine
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
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
Prevenar 13 patients
|
Prevenar 13 vaccine as prescribed by the physician based on approved product indication
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Délai: Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period
|
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported.
An AE was any untoward medical occurrence in a participant who received 13vPnC.
An 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.
AEs included both SAEs and non-SAEs.
|
Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period
|
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
1 décembre 2011
Achèvement primaire (Réel)
1 mai 2014
Achèvement de l'étude (Réel)
1 mai 2014
Dates d'inscription aux études
Première soumission
22 juin 2011
Première soumission répondant aux critères de contrôle qualité
15 juillet 2011
Première publication (Estimation)
18 juillet 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 janvier 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
5 décembre 2016
Dernière vérification
1 janvier 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- B1851076
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 .