Prevenar13 Post Market Surveillance
20 dicembre 2016 aggiornato da: 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.
Panoramica dello studio
Descrizione dettagliata
non-randomization, non-probability sampling
Tipo di studio
Osservativo
Iscrizione (Effettivo)
649
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Busan, Corea, Repubblica di, 602-739
- Busan National University Hospital
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Daegu, Corea, Repubblica di, 701847
- Jaeil Alliance Pediatrics Clinic
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Daegu, Corea, Repubblica di, 702886
- Teun Teun Pediatric Clinic
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Daejeon, Corea, Repubblica di, 302-799
- Eulji University Hospital
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Gyeonggi-do, Corea, Repubblica di, 425-707
- Korea University Ansan Hospital
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Gyeonggi-do, Corea, Repubblica di, 463-712
- CHA Bundang Medical Center, CHA University
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Incheon, Corea, Repubblica di, 400-711
- Inha University Hospital
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Incheon, Corea, Repubblica di, 402-852
- Lee Ha Young Pediatrics
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Seoul, Corea, Repubblica di, 138-736
- Asan Medical Center
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Seoul, Corea, Repubblica di, 139-711
- Eulji Medical Center
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Suyeong-gu, Corea, Repubblica di, 613-806
- JaMo Women's Hospital
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Ulsan, Corea, Repubblica di, 682-714
- Ulsan University Hospital
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Gangwon-do
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Wonju-si, Gangwon-do, Corea, Repubblica di, 220-956
- Choi's Pediatric Clinic
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Gyeonggi-do
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Osan, Gyeonggi-do, Corea, Repubblica di, 447-804
- Seoul Children's Hospital
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Seongnam-si, Gyeonggi-do, Corea, Repubblica di, 463-821
- Bundang Pediatric Clinic
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Suwon-si, Gyeonggi-do, Corea, Repubblica di, 443-471
- Teun Teun Pediatric Clinic
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Yangju, Gyeonggi-do, Corea, Repubblica di, 482-050
- Namujungwon Women's Hospital
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Yongin-si, Gyeonggi-do, Corea, Repubblica di, 448-508
- Yonsei Pediatric Clinic
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 1 mese a 17 anni (Bambino)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Solo caso
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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Gruppo 1
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0.5mL IM (Intramuscular administration) as per recommended schedule
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Lasso di tempo: Within 7 days after Vaccination 1
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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.
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Within 7 days after Vaccination 1
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
Lasso di tempo: Within 7 days after Vaccination 2
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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.
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Within 7 days after Vaccination 2
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3
Lasso di tempo: Within 7 days after Vaccination 3
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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.
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Within 7 days after Vaccination 3
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4
Lasso di tempo: Within 28 days after Vaccination 4
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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.
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Within 28 days after Vaccination 4
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Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Lasso di tempo: Within 7 days after Vaccination 1
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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.
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Within 7 days after Vaccination 1
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Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
Lasso di tempo: Within 7 days after Vaccination 2
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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.
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Within 7 days after Vaccination 2
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Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 3
Lasso di tempo: Within 7 days after Vaccination 3
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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.
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Within 7 days after Vaccination 3
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Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 28 Days After Vaccination 4
Lasso di tempo: Within 28 days after Vaccination 4
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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.
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Within 28 days after Vaccination 4
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Duration of Adverse Events (AEs)
Lasso di tempo: Baseline up to 28 days after last dose of study vaccination (13 Months)
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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.
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Baseline up to 28 days after last dose of study vaccination (13 Months)
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Number of Participants With Adverse Events (AEs) by Severity
Lasso di tempo: Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4
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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).
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Within 7 days after Vaccination 1, 2, 3 and within 28 days after Vaccination 4
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Number of Participants With Outcome in Response to Adverse Events (AEs)
Lasso di tempo: Baseline up to 28 days after last dose of study vaccination (13 Months)
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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'.
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Baseline up to 28 days after last dose of study vaccination (13 Months)
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Number of Participants Discontinued Due to Adverse Events
Lasso di tempo: Baseline up to 28 days after last dose of study vaccination (13 Months)
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An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
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Baseline up to 28 days after last dose of study vaccination (13 Months)
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 settembre 2011
Completamento primario (Effettivo)
1 gennaio 2016
Completamento dello studio (Effettivo)
1 gennaio 2016
Date di iscrizione allo studio
Primo inviato
30 settembre 2011
Primo inviato che soddisfa i criteri di controllo qualità
9 gennaio 2012
Primo Inserito (Stima)
12 gennaio 2012
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
13 febbraio 2017
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 dicembre 2016
Ultimo verificato
1 dicembre 2016
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 6096A1-4029
- B1851057 (Altro identificatore: Alias Study Number)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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