- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01509105
Prevenar13 Post Market Surveillance
20 december 2016 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
non-randomization, non-probability sampling
Studietyp
Observationell
Inskrivning (Faktisk)
649
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Busan, Korea, Republiken av, 602-739
- Busan National University Hospital
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Daegu, Korea, Republiken av, 701847
- Jaeil Alliance Pediatrics Clinic
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Daegu, Korea, Republiken av, 702886
- Teun Teun Pediatric Clinic
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Daejeon, Korea, Republiken av, 302-799
- Eulji University Hospital
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Gyeonggi-do, Korea, Republiken av, 425-707
- Korea University Ansan Hospital
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Gyeonggi-do, Korea, Republiken av, 463-712
- CHA Bundang Medical Center, CHA University
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Incheon, Korea, Republiken av, 400-711
- Inha University Hospital
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Incheon, Korea, Republiken av, 402-852
- Lee Ha Young Pediatrics
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Seoul, Korea, Republiken av, 138-736
- Asan Medical Center
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Seoul, Korea, Republiken av, 139-711
- Eulji Medical Center
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Suyeong-gu, Korea, Republiken av, 613-806
- JaMo Women's Hospital
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Ulsan, Korea, Republiken av, 682-714
- Ulsan University Hospital
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Gangwon-do
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Wonju-si, Gangwon-do, Korea, Republiken av, 220-956
- Choi's Pediatric Clinic
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Gyeonggi-do
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Osan, Gyeonggi-do, Korea, Republiken av, 447-804
- Seoul Children's Hospital
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Seongnam-si, Gyeonggi-do, Korea, Republiken av, 463-821
- Bundang Pediatric Clinic
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Suwon-si, Gyeonggi-do, Korea, Republiken av, 443-471
- Teun Teun Pediatric Clinic
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Yangju, Gyeonggi-do, Korea, Republiken av, 482-050
- Namujungwon Women's Hospital
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Yongin-si, Gyeonggi-do, Korea, Republiken av, 448-508
- Yonsei Pediatric Clinic
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
1 månad till 17 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Endast fall
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Grupp 1
|
0.5mL IM (Intramuscular administration) as per recommended schedule
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Duration of Adverse Events (AEs)
Tidsram: 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
Tidsram: 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).
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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)
Tidsram: 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'.
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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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2011
Primärt slutförande (Faktisk)
1 januari 2016
Avslutad studie (Faktisk)
1 januari 2016
Studieregistreringsdatum
Först inskickad
30 september 2011
Först inskickad som uppfyllde QC-kriterierna
9 januari 2012
Första postat (Uppskatta)
12 januari 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 februari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 december 2016
Senast verifierad
1 december 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 6096A1-4029
- B1851057 (Annan identifierare: Alias Study Number)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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