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)
  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

English

Telephone contact

1 forms  
  1. StudyEvent: ODM
    1. Telephone contact
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Telephone contact
Description

Telephone contact

Alias
UMLS CUI-1
C0420309
Has the above information been obtained?
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
Telephone contact date
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
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Similar models

Telephone contact

1 forms
  1. StudyEvent: ODM
    1. Telephone contact
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Telephone contact
C0420309 (UMLS CUI-1)
Item
Has the above information been obtained?
text
C0420309 (UMLS CUI [1,1])
C1880174 (UMLS CUI [1,2])
Telephone contact, information
Code List
Has the above information been obtained?
CL Item
Yes (Y)
CL Item
No (N)
Telephone contact date
Item
Telephone contact date
date
C0302186 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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