ID
35829
Description
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 Telephone contact form. It has to be filled in for the telephone contact visit.
Link
https://clinicaltrials.gov/ct2/show/NCT00510874
Keywords
Versions (1)
- 3/25/19 3/25/19 -
Copyright Holder
GlaxoSmithKline
Uploaded on
March 25, 2019
DOI
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License
Creative Commons BY-NC 3.0
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Safety and Immune Response of Two-Doses of Candidate Influenza Vaccine in Adults, NCT00510874
Telephone contact
- StudyEvent: ODM
Description
Telephone contact
Alias
- UMLS CUI-1
- C0420309
Description
Please contact/query subject to: -Subjects will be queried for AEs present at Visit 'Day 42' and any new AEs since 'Day 42' and these will be recorded. -Subjects will be queried for SAEs, and these will be recorded and reported. The subject will be instructed to contact the investigator immediately should the subject manifest any signs or symptoms they perceive as serious. -Subjects will be queried for new medications/vaccinations taken since the last visit. -The investigator will, at his/her discretion, schedule an ad hoc follow-up clinic visit to evaluate any AE or other change detected in subject status that is deemed to be medically significant.
Data type
text
Alias
- UMLS CUI [1,1]
- C0420309
- UMLS CUI [1,2]
- C1880174
Description
day month year. Complete if the telephone contact information has been obtained.
Data type
date
Alias
- UMLS CUI [1,1]
- C0302186
- UMLS CUI [1,2]
- C0011008
Similar models
Telephone contact
- StudyEvent: ODM
C1880174 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])