ID

24169

Beschreibung

Study ID: 100577 Clinical Study ID: 100577 Study Title: Double-blind, randomized study to evaluate the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine containing 1440 EL.U of antigen per mL and injected according to a 0, 6 month schedule in healthy adult subjects Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289757 https://clinicaltrials.gov/ct2/show/NCT00289757 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 4 Study Recruitment Status: Completed Generic Name: Hepatitis A Vaccine, Inactivated Trade Name: Havrix Study Indication: Hepatitis A Documentation part: Tracking Document, Long Term Follow-up

Link

https://clinicaltrials.gov/ct2/show/NCT00289757

Stichworte

Versionen (1)
  1. 27.07.17 27.07.17 -
Hochgeladen am

27. Juli 2017

DOI

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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Serious Long Term Follow-up 100577

Englisch

Long Term Follow-up Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100577

1 Formulare  
Long Term Follow-up
Beschreibung

Long Term Follow-up

Alias
UMLS CUI-1
C1517942 (Long-term Follow-up)
UMLS CUI-2
C0170300 (Hepatitis A Vaccines)
SNOMED
871751006
Subject number of previous study
Beschreibung

Subject number of previous study

Datentyp

text

Alias
UMLS CUI [1,1]
C2348585 (Clinical Trial Subject Unique Identifier)
UMLS CUI [1,2]
C2242969 (clinical trial participant (history))
Subject initials
Beschreibung

Subject initials

Datentyp

text

Alias
UMLS CUI [1,1]
C2986440 (Person Initials)
UMLS CUI [1,2]
C0681850 (Study Subject)
Date of birth
Beschreibung

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451 (Patient date of birth)
SNOMED
184099003
LOINC
LP57552-9
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
Beschreibung

long-term follow-up study participation

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348568 (Study Subject Participation Status)
UMLS CUI [1,2]
C1517942 (Long-term Follow-up)
UMLS CUI [1,3]
C0170300 (Hepatitis A Vaccines)
SNOMED
871751006
Subject eligible but not willing to participate due to:
Beschreibung

long-term follow-up study participation

Datentyp

integer

Alias
UMLS CUI [1,1]
C2348568 (Study Subject Participation Status)
UMLS CUI [1,2]
C1517942 (Long-term Follow-up)
UMLS CUI [1,3]
C0170300 (Hepatitis A Vaccines)
SNOMED
871751006
If adverse events, or serious adverse event, please specify
Beschreibung

Subject eligible but not willing to participate due to

Datentyp

text

Alias
UMLS CUI [1]
C0877248 (Adverse event)
LOINC
MTHU014542
UMLS CUI [2,1]
C2348568 (Study Subject Participation Status)
UMLS CUI [2,2]
C1517942 (Long-term Follow-up)
UMLS CUI [2,3]
C0170300 (Hepatitis A Vaccines)
SNOMED
871751006
If Other, please specify
Beschreibung

Subject eligible but not willing to participate due to

Datentyp

text

Alias
UMLS CUI [1,1]
C2348568 (Study Subject Participation Status)
UMLS CUI [1,2]
C1517942 (Long-term Follow-up)
UMLS CUI [1,3]
C0170300 (Hepatitis A Vaccines)
SNOMED
871751006
Investigator signature
Beschreibung

Investigator signature

Datentyp

text

Alias
UMLS CUI [1]
C2346576 (Investigator Signature)
Investigator signature date
Beschreibung

Investigator signature date

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576 (Investigator Signature)
UMLS CUI [1,2]
C0011008 (Date in time)
SNOMED
410671006
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Ähnliche Modelle

Long Term Follow-up Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 100577

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Long Term Follow-up
C1517942 (UMLS CUI-1)
C0170300 (UMLS CUI-2)
Subject number of previous study
Item
Subject number of previous study
text
C2348585 (UMLS CUI [1,1])
C2242969 (UMLS CUI [1,2])
Subject initials
Item
Subject initials
text
C2986440 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
integer
C2348568 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
C0170300 (UMLS CUI [1,3])
long-term follow-up study participation
Code List
Please contact the following subjects for inclusion in the long-term follow-up study and document whether or not he/she agrees to participate.
CL Item
Subject not eligible (1)
CL Item
Subject lost to follow-up or not reached  (2)
CL Item
Subject eligible but not willing to participate due to: (3)
CL Item
Subject eligible and agreed to participate in the long-term follow-up study (4)
Item
Subject eligible but not willing to participate due to:
integer
C2348568 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
C0170300 (UMLS CUI [1,3])
undefined item
Code List
Subject eligible but not willing to participate due to:
CL Item
adverse events, or serious adverse event (1)
CL Item
Other (2)
long-term follow-up study participation
Item
If adverse events, or serious adverse event, please specify
text
C0877248 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C1517942 (UMLS CUI [2,2])
C0170300 (UMLS CUI [2,3])
long-term follow-up study participation
Item
If Other, please specify
text
C2348568 (UMLS CUI [1,1])
C1517942 (UMLS CUI [1,2])
C0170300 (UMLS CUI [1,3])
Investigator signature
Item
Investigator signature
text
C2346576 (UMLS CUI [1])
Investigator signature date
Item
Investigator signature date
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Zum Seitenanfang zurückkehren 

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