Prevenar13 Post Market Surveillance
20. december 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
non-randomization, non-probability sampling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
649
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Busan, Korea, Republikken, 602-739
- Busan National University Hospital
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Daegu, Korea, Republikken, 701847
- Jaeil Alliance Pediatrics Clinic
-
Daegu, Korea, Republikken, 702886
- Teun Teun Pediatric Clinic
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Daejeon, Korea, Republikken, 302-799
- Eulji University Hospital
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Gyeonggi-do, Korea, Republikken, 425-707
- Korea University Ansan Hospital
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Gyeonggi-do, Korea, Republikken, 463-712
- CHA Bundang Medical Center, CHA University
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Incheon, Korea, Republikken, 400-711
- Inha University Hospital
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Incheon, Korea, Republikken, 402-852
- Lee Ha Young Pediatrics
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Seoul, Korea, Republikken, 138-736
- Asan Medical Center
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Seoul, Korea, Republikken, 139-711
- Eulji Medical Center
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Suyeong-gu, Korea, Republikken, 613-806
- JaMo Women's Hospital
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Ulsan, Korea, Republikken, 682-714
- Ulsan University Hospital
-
-
Gangwon-do
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Wonju-si, Gangwon-do, Korea, Republikken, 220-956
- Choi's Pediatric Clinic
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-
Gyeonggi-do
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Osan, Gyeonggi-do, Korea, Republikken, 447-804
- Seoul Children's Hospital
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Seongnam-si, Gyeonggi-do, Korea, Republikken, 463-821
- Bundang Pediatric Clinic
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Suwon-si, Gyeonggi-do, Korea, Republikken, 443-471
- Teun Teun Pediatric Clinic
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Yangju, Gyeonggi-do, Korea, Republikken, 482-050
- Namujungwon Women's Hospital
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Yongin-si, Gyeonggi-do, Korea, Republikken, 448-508
- Yonsei Pediatric Clinic
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 måned til 17 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kun etui
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Gruppe 1
|
0.5mL IM (Intramuscular administration) as per recommended schedule
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration of Adverse Events (AEs)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2011
Primær færdiggørelse (Faktiske)
1. januar 2016
Studieafslutning (Faktiske)
1. januar 2016
Datoer for studieregistrering
Først indsendt
30. september 2011
Først indsendt, der opfyldte QC-kriterier
9. januar 2012
Først opslået (Skøn)
12. januar 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. februar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. december 2016
Sidst verificeret
1. december 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 6096A1-4029
- B1851057 (Anden identifikator: Alias Study Number)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .