ID

35115

Description

Study ID: 107495 Clinical Study ID: 107495 Study Title: A phase II, open, randomized study in adults aged between 18 and 60 years designed to evaluate the reactogenicity and immunogenicity of a 1- and 2-dose prime-boost concept of pandemic monovalent (H5N1) influenza vaccine (split virus formulation) adjuvanted with AS03, administered according to different vaccination schedules. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00430521 https://clinicaltrials.gov/ct2/show/NCT00430521 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Pandemic influenza vaccine (GSK1119711A)-formulation 1, Pandemic influenza vaccine (GSK1119711A)-formulation 2 Trade Name: N/A Study Indication: Influenza There are 4 workbooks (WB): WB 1: Protocol 107495, (H5N1-012), Groups: VT/VT/6Mo, VT/IN/6Mo WB 2: Protocol 107495, (H5N1-012), Groups: VT/VT/12Mo, VT/IN/12Mo WB 3: Protocol 107495 (H5N1-012) GROUPS: 2VT/VT/6MO, 2VT/IN/6MO WB 4: Protocol 107495 (H5N1-012) Groups: 2VT/VT/12Mo, 2VT/IN/12Mo Every Workbook has the following visits: Visit Day 0 (Screening, Dose 1), Visit Day 21, Visit Month 6, Visit Month 12 and Visit Month 18. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section, followed by a final study conclusion after Month 18. Workbook 1 schedules a vaccination at screening and Month 6 each, Workbook 2 at Screening and Month 12. 30 days after the first vaccination there is an additional telephone contact. After the second vaccination additional visits/contacts are necessary in both workbooks: a visit at Month 6/12 + 7 and 21 days and a telephone contact on Month 6/12 + 30 days. Workbook 3 schedules a vaccination at screening, Day 21 and Month 6 and Workbook 4 at screening, Day 21 and Month 12. After the second vaccination there is an additional visit on Day 42 and a telephone contact on day 51. After the third vaccination there are additional visits/contacts: visits at Month 6/12 + 7 and 21 days and a telephone contact at Month 6/12 + 30 days. After Month 6 (+30 days, if applicable) and Month 12 (+30 days, if applicable) there is a Core Analysis section. This document contains the demography, informed consent and randomisation/ treatment allocation form. It has to be filled in for screening for all workbooks (WB1-4).

Link

https://clinicaltrials.gov/ct2/show/NCT00430521

Keywords

  1. 2/18/19 2/18/19 -
  2. 9/20/21 9/20/21 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 18, 2019

DOI

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License

Creative Commons BY-NC 3.0

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Evaluation of reactogenicity and immunogenicity of pandemic monovalent (H5N1) influenza vaccine in adults, NCT00430521

Demography, informed consent, randomisation/ treatment allocation

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Protocol Identifier
Description

Protocol Identifier

Data type

integer

Alias
UMLS CUI [1]
C2826693
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Workbook number
Description

Workbook number

Data type

integer

Alias
UMLS CUI [1]
C2986015
Informed consent
Description

Informed consent

Alias
UMLS CUI-1
C0021430
Informed Consent Date
Description

"I certify that Informed Consent has been obtained prior to any study procedure". day month year

Data type

date

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0011008
Randomisation/ Treatment Allocation
Description

Randomisation/ Treatment Allocation

Alias
UMLS CUI-1
C1522541
Record treatment number
Description

Treatment number identifier

Data type

text

Alias
UMLS CUI [1]
C1522541
Demography
Description

Demography

Alias
UMLS CUI-1
C0011298
Center number
Description

Center number

Data type

text

Alias
UMLS CUI [1,1]
C1301943
UMLS CUI [1,2]
C0600091
Date of birth
Description

day month year

Data type

date

Alias
UMLS CUI [1]
C0421451
Sex
Description

Sex

Data type

text

Alias
UMLS CUI [1]
C0079399
Ethnicity
Description

Ethnicity

Data type

integer

Alias
UMLS CUI [1]
C0015031
Race
Description

Race

Alias
UMLS CUI-1
C0034510
African American/African Heritage
Description

A person having origins in any of the black racial groups of Africa

Data type

boolean

Alias
UMLS CUI [1]
C0085756
UMLS CUI [2]
C0027567
American Indian or Alaskan Native
Description

A person having origins in any of the original peoples of North and South America (including Central America) and who maintains tribal affiliation or community attachment

Data type

boolean

Alias
UMLS CUI [1]
C1515945
Asian - Central/South Asian Heritage
Description

A person having origins in Central Asia and Indian Subcontinent (India, Pakistan, Bangladesh and Sri Lanka)

Data type

boolean

Alias
UMLS CUI [1]
C0238696
UMLS CUI [2]
C1519427
Asian - East Asian Heritage
Description

A person having origins in China, Korea

Data type

boolean

Alias
UMLS CUI [1]
C4540996
Asian - Japanese Heritage
Description

A person having origins in Japan

Data type

boolean

Alias
UMLS CUI [1]
C1556094
Asian - South East Asian Heritage
Description

A person having origins in Malaysia, the Philippines, Indonesia, Thailand, Vietnam, Laos, Burma or Cambodia

Data type

boolean

Alias
UMLS CUI [1]
C0238697
Native Hawaiian or Other Pacific Islander
Description

A person having origins in any of the original peoples of Hawaii, Guam, Samoa or other Pacific Islands, Australia (Aborigines), Papua New Guinea, New Zealand, Marshalls and other island groups west and south of Japan

Data type

boolean

Alias
UMLS CUI [1]
C1513907
White - Arabic/North African Heritage
Description

A person having origins in any of the original peoples of Middle East or North Africa

Data type

boolean

Alias
UMLS CUI [1]
C0238604
UMLS CUI [2]
C2698217
White - Caucasian/European Heritage
Description

A person having origins in any of the original peoples of Europe

Data type

boolean

Alias
UMLS CUI [1]
C0043157
Other racial group
Description

Other racial group

Data type

boolean

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
If other racial group, please specify
Description

Other racial group, specification

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394

Similar models

Demography, informed consent, randomisation/ treatment allocation

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Protocol Identifier
Item
Protocol Identifier
integer
C2826693 (UMLS CUI [1])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item
Workbook number
integer
C2986015 (UMLS CUI [1])
Code List
Workbook number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
CL Item
WB 3 (3)
CL Item
WB 4 (4)
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C0021430 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Randomisation/ Treatment Allocation
C1522541 (UMLS CUI-1)
Treatment number identifier
Item
Record treatment number
text
C1522541 (UMLS CUI [1])
Item Group
Demography
C0011298 (UMLS CUI-1)
Center number
Item
Center number
text
C1301943 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Date of birth
Item
Date of birth
date
C0421451 (UMLS CUI [1])
Item
Sex
text
C0079399 (UMLS CUI [1])
Code List
Sex
CL Item
Male (M)
C0086582 (UMLS CUI-1)
(Comment:en)
CL Item
Female (F)
C0015780 (UMLS CUI-1)
(Comment:en)
Item
Ethnicity
integer
C0015031 (UMLS CUI [1])
Code List
Ethnicity
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
Item Group
Race
C0034510 (UMLS CUI-1)
African American/African Heritage
Item
African American/African Heritage
boolean
C0085756 (UMLS CUI [1])
C0027567 (UMLS CUI [2])
American Indian or Alaskan Native
Item
American Indian or Alaskan Native
boolean
C1515945 (UMLS CUI [1])
Asian - Central/South Asian Heritage
Item
Asian - Central/South Asian Heritage
boolean
C0238696 (UMLS CUI [1])
C1519427 (UMLS CUI [2])
Asian - East Asian Heritage
Item
Asian - East Asian Heritage
boolean
C4540996 (UMLS CUI [1])
Asian - Japanese Heritage
Item
Asian - Japanese Heritage
boolean
C1556094 (UMLS CUI [1])
Asian - South East Asian Heritage
Item
Asian - South East Asian Heritage
boolean
C0238697 (UMLS CUI [1])
Native Hawaiian or Other Pacific Islander
Item
Native Hawaiian or Other Pacific Islander
boolean
C1513907 (UMLS CUI [1])
White - Arabic/North African Heritage
Item
White - Arabic/North African Heritage
boolean
C0238604 (UMLS CUI [1])
C2698217 (UMLS CUI [2])
White - Caucasian/European Heritage
Item
White - Caucasian/European Heritage
boolean
C0043157 (UMLS CUI [1])
Other racial group
Item
Other racial group
boolean
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
Other racial group, specification
Item
If other racial group, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

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