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Prevenar13 Post Market Surveillance

20. desember 2016 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

non-randomization, non-probability sampling

Studietype

Observasjonsmessig

Registrering (Faktiske)

649

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

1 måned til 17 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Bare etui
  • Tidsperspektiver: Potensielle

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
Gruppe1
Biologisk: 13-valent pneumococcal vaccine
0.5mL IM (Intramuscular administration) as per recommended schedule
Andre navn:
  • Prevenar 13

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Pfizer

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2011

Primær fullføring (Faktiske)

1. januar 2016

Studiet fullført (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først innsendt

30. september 2011

Først innsendt som oppfylte QC-kriteriene

9. januar 2012

Først lagt ut (Anslag)

12. januar 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. februar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. desember 2016

Sist bekreftet

1. desember 2016

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 6096A1-4029
  • B1851057 (Annen identifikator: Alias Study Number)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Sunn

Kliniske studier på 13-valent pneumococcal vaccine

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Georgia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

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