ID
26121
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: Serious Adverse Event
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 Serious Adverse Event 111029
Serious Adverse Event Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111029
Beschrijving
Study vaccine information
Alias
- UMLS CUI-1
- C0042210
- UMLS CUI-2
- C0170300
- UMLS CUI-3
- C0304229
Beschrijving
Vaccine
Datatype
text
Alias
- UMLS CUI [1]
- C0042210
Beschrijving
Dose No
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [2]
- C0042210
Beschrijving
Lot Number
Datatype
integer
Alias
- UMLS CUI [1]
- C2826710
- UMLS CUI [2]
- C0042210
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beschrijving
Site
Datatype
text
Alias
- UMLS CUI [1,1]
- C1515974
- UMLS CUI [1,2]
- C0042210
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0042210
- UMLS CUI [1,2]
- C0011008
Beschrijving
Concomitant medication / vaccination that could have contributed to this SAE
Alias
- UMLS CUI-1
- C2347852
- UMLS CUI-2
- C0042210
Beschrijving
Concomitant medication / vaccination that could have contributed to this SAE
Datatype
text
Alias
- UMLS CUI [1,1]
- C2347852
- UMLS CUI [1,2]
- C2360065
- UMLS CUI [2]
- C1519255
Beschrijving
Dosage
Datatype
float
Alias
- UMLS CUI [1,1]
- C3174092
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C1519255
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1,1]
- C3476109
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C1519255
Beschrijving
Route
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C1519255
Beschrijving
Start Date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C1519255
Beschrijving
Stop date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C2347852
- UMLS CUI [2]
- C1519255
Beschrijving
Drug(s) used to treat this SAE
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0087111
- UMLS CUI-3
- C1519255
Beschrijving
Drug name
Datatype
text
Alias
- UMLS CUI [1]
- C2360065
Beschrijving
Dosage
Datatype
text
Alias
- UMLS CUI [1,1]
- C0178602
- UMLS CUI [1,2]
- C0013227
Beschrijving
Frequency
Datatype
text
Alias
- UMLS CUI [1]
- C3476109
Beschrijving
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
Surgical treatment
Datatype
text
Alias
- UMLS CUI [1,1]
- C0543467
- UMLS CUI [1,2]
- C1519255
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Serious Adverse Event Immunogenicity and reactogenicity of GlaxoSmithKline Biologicals' inactivated hepatitis A vaccine 111029
C0011900 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [2])
C2826307 (UMLS CUI [2])
C0808070 (UMLS CUI [1,2])
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C1519255 (UMLS CUI [1,2])
C0170300 (UMLS CUI [1,2])
C0085978 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,4])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0170300 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,3])
C1519255 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C0012634 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C1519255 (UMLS CUI [1,2])
C0170300 (UMLS CUI-2)
C0304229 (UMLS CUI-3)
C0449788 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2])
C0042210 (UMLS CUI [2])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI-2)
C2360065 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C2347852 (UMLS CUI [1,2])
C1519255 (UMLS CUI [2])
C0087111 (UMLS CUI-2)
C1519255 (UMLS CUI-3)
C0013227 (UMLS CUI [1,2])
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])
C1519255 (UMLS CUI [1,2])