ID
35824
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 Concomitant Vaccination form. It has to be filled in for 2 phases: Active phase and after telephone contact phase. At each study visit/telephone contact, the investigator should question the subject' about any vaccine administered.
Link
https://clinicaltrials.gov/ct2/show/NCT00510874
Trefwoorden
Versies (1)
- 25-03-19 25-03-19 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
25 maart 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874
Concomitant Vaccination
- StudyEvent: ODM
Beschrijving
Concomitant Vaccination
Alias
- UMLS CUI-1
- C0042196
- UMLS CUI-2
- C2347852
Beschrijving
Any vaccine not foreseen in the study protocol is to be recorded as a concomitant vaccination with trade name, route of administration and date(s) of administration. Any investigational vaccine administered throughout the study (i.e. from Visit "Day 0" through Visit "Day 42") must be recorded in the eCRF.
Datatype
text
Alias
- UMLS CUI [1,1]
- C0042196
- UMLS CUI [1,2]
- C2347852
Beschrijving
Trade / Generic Name of vaccine
Datatype
text
Alias
- UMLS CUI [1,1]
- C2360065
- UMLS CUI [1,2]
- C0042210
Beschrijving
Route of vaccine administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013153
- UMLS CUI [1,2]
- C0042210
Beschrijving
day month year
Datatype
date
Alias
- UMLS CUI [1,1]
- C1533734
- UMLS CUI [1,2]
- C0042210
- UMLS CUI [1,3]
- C0011008
Beschrijving
Comment for GSK
Datatype
text
Alias
- UMLS CUI [1,1]
- C0947611
- UMLS CUI [1,2]
- C0008961
Similar models
Concomitant Vaccination
- StudyEvent: ODM
C2347852 (UMLS CUI-2)
C2347852 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0008961 (UMLS CUI [1,2])