Prevenar13 Post Market Surveillance
20 grudnia 2016 zaktualizowane przez: 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.
Przegląd badań
Szczegółowy opis
non-randomization, non-probability sampling
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
649
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Busan, Republika Korei, 602-739
- Busan National University Hospital
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Daegu, Republika Korei, 701847
- Jaeil Alliance Pediatrics Clinic
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Daegu, Republika Korei, 702886
- Teun Teun Pediatric Clinic
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Daejeon, Republika Korei, 302-799
- Eulji University Hospital
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Gyeonggi-do, Republika Korei, 425-707
- Korea University Ansan Hospital
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Gyeonggi-do, Republika Korei, 463-712
- CHA Bundang Medical Center, CHA University
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Incheon, Republika Korei, 400-711
- Inha University Hospital
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Incheon, Republika Korei, 402-852
- Lee Ha Young Pediatrics
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Seoul, Republika Korei, 138-736
- Asan Medical Center
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Seoul, Republika Korei, 139-711
- Eulji Medical Center
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Suyeong-gu, Republika Korei, 613-806
- JaMo Women's Hospital
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Ulsan, Republika Korei, 682-714
- Ulsan University Hospital
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Gangwon-do
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Wonju-si, Gangwon-do, Republika Korei, 220-956
- Choi's Pediatric Clinic
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Gyeonggi-do
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Osan, Gyeonggi-do, Republika Korei, 447-804
- Seoul Children's Hospital
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Seongnam-si, Gyeonggi-do, Republika Korei, 463-821
- Bundang Pediatric Clinic
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Suwon-si, Gyeonggi-do, Republika Korei, 443-471
- Teun Teun Pediatric Clinic
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Yangju, Gyeonggi-do, Republika Korei, 482-050
- Namujungwon Women's Hospital
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Yongin-si, Gyeonggi-do, Republika Korei, 448-508
- Yonsei Pediatric Clinic
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
1 miesiąc do 17 lat (Dziecko)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Tylko przypadek
- Perspektywy czasowe: Spodziewany
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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Grupa 1
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0.5mL IM (Intramuscular administration) as per recommended schedule
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Ramy czasowe: 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
Ramy czasowe: 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.
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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
Ramy czasowe: 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.
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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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Duration of Adverse Events (AEs)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 września 2011
Zakończenie podstawowe (Rzeczywisty)
1 stycznia 2016
Ukończenie studiów (Rzeczywisty)
1 stycznia 2016
Daty rejestracji na studia
Pierwszy przesłany
30 września 2011
Pierwszy przesłany, który spełnia kryteria kontroli jakości
9 stycznia 2012
Pierwszy wysłany (Oszacować)
12 stycznia 2012
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
13 lutego 2017
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
20 grudnia 2016
Ostatnia weryfikacja
1 grudnia 2016
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 6096A1-4029
- B1851057 (Inny identyfikator: Alias Study Number)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .