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Prevenar13 Post Market Surveillance
20 december 2016 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
non-randomization, non-probability sampling
Studietype
Observationeel
Inschrijving (Werkelijk)
649
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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-
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Busan, Korea, republiek van, 602-739
- Busan National University Hospital
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Daegu, Korea, republiek van, 701847
- Jaeil Alliance Pediatrics Clinic
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Daegu, Korea, republiek van, 702886
- Teun Teun Pediatric Clinic
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Daejeon, Korea, republiek van, 302-799
- Eulji University Hospital
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Gyeonggi-do, Korea, republiek van, 425-707
- Korea University Ansan Hospital
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Gyeonggi-do, Korea, republiek van, 463-712
- CHA Bundang Medical Center, CHA University
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Incheon, Korea, republiek van, 400-711
- Inha University Hospital
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Incheon, Korea, republiek van, 402-852
- Lee Ha Young Pediatrics
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Seoul, Korea, republiek van, 138-736
- Asan Medical Center
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Seoul, Korea, republiek van, 139-711
- Eulji Medical Center
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Suyeong-gu, Korea, republiek van, 613-806
- JaMo Women's Hospital
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Ulsan, Korea, republiek van, 682-714
- Ulsan University Hospital
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Gangwon-do
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Wonju-si, Gangwon-do, Korea, republiek van, 220-956
- Choi's Pediatric Clinic
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Gyeonggi-do
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Osan, Gyeonggi-do, Korea, republiek van, 447-804
- Seoul Children's Hospital
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Seongnam-si, Gyeonggi-do, Korea, republiek van, 463-821
- Bundang Pediatric Clinic
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Suwon-si, Gyeonggi-do, Korea, republiek van, 443-471
- Teun Teun Pediatric Clinic
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Yangju, Gyeonggi-do, Korea, republiek van, 482-050
- Namujungwon Women's Hospital
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Yongin-si, Gyeonggi-do, Korea, republiek van, 448-508
- Yonsei Pediatric Clinic
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
1 maand tot 17 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
All infants and children meeting the usual prescribing criteria for Prevenar 13 as per the local product information for usage
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-Alleen
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
Groep 1
|
0.5mL IM (Intramuscular administration) as per recommended schedule
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 1
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
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Number of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs): Within 7 Days After Vaccination 2
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Duration of Adverse Events (AEs)
Tijdsspanne: 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)
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Number of Participants With Adverse Events (AEs) by Severity
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2011
Primaire voltooiing (Werkelijk)
1 januari 2016
Studie voltooiing (Werkelijk)
1 januari 2016
Studieregistratiedata
Eerst ingediend
30 september 2011
Eerst ingediend dat voldeed aan de QC-criteria
9 januari 2012
Eerst geplaatst (Schatting)
12 januari 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
13 februari 2017
Laatste update ingediend die voldeed aan QC-criteria
20 december 2016
Laatst geverifieerd
1 december 2016
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 6096A1-4029
- B1851057 (Andere identificatie: Alias Study Number)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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