ID
26126
Beschrijving
Study ID: 111029 Clinical Study ID: 111029 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: Concomitant Vaccination, Long Term Follow-Up Year 17
Link
https://clinicaltrials.gov/ct2/show/NCT00289757
Trefwoorden
Versies (1)
- 09-10-17 09-10-17 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
9 oktober 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine Concomitant Vaccination 111029
Concomitant Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111029
Beschrijving
Medication
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- C0042196
Beschrijving
treatments
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0087111
Beschrijving
Trade name
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Medical Indication
Datatype
text
Alias
- UMLS CUI [1,1]
- C3146298
- UMLS CUI [1,2]
- C0013227
Beschrijving
Prophylactic
Datatype
boolean
Alias
- UMLS CUI [1]
- C0199176
Beschrijving
Total daily dose
Datatype
float
Alias
- UMLS CUI [1]
- C2348070
Beschrijving
Administration Route
Datatype
text
Alias
- UMLS CUI [1]
- C0013153
Beschrijving
Start date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0808070
Beschrijving
End date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0013227
- UMLS CUI [1,2]
- C0806020
Beschrijving
Continuing Therapy
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1553904
- UMLS CUI [1,2]
- C0013227
Beschrijving
Non-serious Adverse Events
Alias
- UMLS CUI-1
- C1518404
- UMLS CUI-2
- C0042210
Beschrijving
Subject Number
Datatype
text
Alias
- UMLS CUI [1]
- C2348585
Beschrijving
(Please report all serious adverse events only on the Serious Adverse Event (SAE) form).
Datatype
integer
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Adverse Event Number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0237753
Beschrijving
Description
Datatype
text
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1518404
Beschrijving
Description
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0678257
- UMLS CUI [1,2]
- C1518404
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0808070
Beschrijving
Start
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0439659
- UMLS CUI [1,2]
- C1518404
Beschrijving
End Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1518404
- UMLS CUI [1,2]
- C0806020
Beschrijving
Maximum Intensity
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1710056
- UMLS CUI [1,2]
- C1518404
Beschrijving
Causality
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [1,3]
- C0085978
- UMLS CUI [1,4]
- C1518404
Beschrijving
Outcome
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1705586
- UMLS CUI [1,2]
- C1518404
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Concomitant Vaccination Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111029
C2347852 (UMLS CUI-2)
C0700881 (UMLS CUI-3)
C2347852 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,2])
C0042210 (UMLS CUI-2)
C0237753 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1518404 (UMLS CUI [1,4])