ID
35767
Beschrijving
Study ID: 110028 Clinical Study ID: 110028 Study Title: Study to Evaluate the Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine GSK 1557484A in Adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00510874 https://clinicaltrials.gov/ct2/show/NCT00510874 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: Candidate Influenza Vaccine Trade Name: Pumarix, Pandemrix Study Indication: Influenza This study consists of 6 Visits and one Telephone Contact: -Visit 1: Visit „Day 0“ -Visit 2: Visit „Day 7“, Contact Window: Day 6-8, Minimum Number of Days between Successive Visits: 6 -Visit 3: Visit „Day 21“: Contact Window: Day 19-23, Minimum Number of Days between Successive Visits: 12 -Visit 4: Visit „Day 28“: Contact Window: Day 26-30, Minimum Number of Days between Successive Visits: 6 -Visit 5: Visit „Day 42“: Contact Window: Day 38-46, Minimum Number of Days between Successive Visits: 12 -Telephone Contact „Day 84“: Contact Window: Day 80-88 -Visit 6: Visit „Day 182“: Contact Window: Day 167-197 The screening can take place up to 21 days prior to Visit 1. This document contains the Demography and Informed consent form. It has to be filled in for screening.
Link
https://clinicaltrials.gov/ct2/show/NCT00510874
Trefwoorden
Versies (3)
- 20-03-19 20-03-19 -
- 20-03-19 20-03-19 -
- 21-03-19 21-03-19 - Sarah Riepenhausen
Houder van rechten
GlaxoSmithKline
Geüploaded op
21 maart 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874
Demography, Informed consent
- StudyEvent: ODM
Beschrijving
Demography
Alias
- UMLS CUI-1
- C0011298
Beschrijving
Center number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1301943
- UMLS CUI [1,2]
- C0600091
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1]
- C0421451
Beschrijving
Sex
Datatype
text
Alias
- UMLS CUI [1]
- C0079399
Beschrijving
Height (cm unit)
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Only for US.
Datatype
integer
Maateenheden
- feet
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Only for US.
Datatype
integer
Maateenheden
- inches
Alias
- UMLS CUI [1]
- C0005890
Beschrijving
Weight (kg unit)
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Only for US.
Datatype
integer
Maateenheden
- pounds
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Only for US.
Datatype
integer
Maateenheden
- ounces
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Geographic Ancestry
Alias
- UMLS CUI-1
- C0034510
Beschrijving
Ethnicity
Datatype
integer
Alias
- UMLS CUI [1]
- C0015031
Beschrijving
African American/African Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Beschrijving
American Indian or Alaskan Native
Datatype
boolean
Alias
- UMLS CUI [1]
- C1515945
Beschrijving
Asian - Central/South Asian Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Beschrijving
Asian - East Asian Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C4540996
Beschrijving
Asian - Japanese Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C1556094
Beschrijving
Asian - South East Asian Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C0238697
Beschrijving
Native Hawaiian or Other Pacific Islander
Datatype
boolean
Alias
- UMLS CUI [1]
- C1513907
Beschrijving
White - Arabic/North African Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C2698217
Beschrijving
White - Caucasian/European Heritage
Datatype
boolean
Alias
- UMLS CUI [1]
- C0043157
Beschrijving
Other Race
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C0205394
Beschrijving
Other Race, specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C0034510
- UMLS CUI [1,2]
- C2348235
Beschrijving
Informed consent
Alias
- UMLS CUI-1
- C0021430
Beschrijving
Informed Consent
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021430
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C0021430
- UMLS CUI [1,2]
- C0011008
Beschrijving
Agreement to use of biological samples(s) for other research
Datatype
text
Alias
- UMLS CUI [1,1]
- C3641827
- UMLS CUI [1,2]
- C1524063
- UMLS CUI [1,3]
- C0178913
- UMLS CUI [1,4]
- C0205394
- UMLS CUI [1,5]
- C0035168
Similar models
Demography, Informed consent
- StudyEvent: ODM
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C2698217 (UMLS CUI [2])
C0205394 (UMLS CUI [1,2])
C2348235 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1524063 (UMLS CUI [1,2])
C0178913 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
C0035168 (UMLS CUI [1,5])