ID

35054

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 general medical history/ physical examination form. It has to be filled in for screening for all workbooks (wb1-4). If deemed necessary by the investigator fill in this document for: WB 1 for "Visit Month 6" WB 2 for "Visit Month 12" WB 3 for "Visit Day 21" and "Visit Month 6" WB 4 for "Visit Day 21" and "Visit Month 12"

Link

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

Keywords

  1. 2/12/19 2/12/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

February 12, 2019

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

Medical history/ physical examination

Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Workbook number
Description

Workbook number

Data type

integer

Alias
UMLS CUI [1]
C2986015
Visit type
Description

For Screening it's necessary. The others are optional if deemed necessary by the investigator.

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0545082
Visit Date
Description

Visit Date

Data type

date

Alias
UMLS CUI [1]
C1320303
Physical Examination, Medical history
Description

Physical Examination, Medical history

Alias
UMLS CUI-1
C0031809
UMLS CUI-2
C0262926
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
Description

If you tick yes, please give diagnosis and tick following Past/Current box(es).

Data type

text

Alias
UMLS CUI [1]
C0521987
UMLS CUI [2,1]
C2347662
UMLS CUI [2,2]
C0037088
MedDRA System Organ Class
Description

To immune system: incl allergies, autoimmune disorders To eoplasms benign, malignant and unspecified: incl cysts, polyps

Data type

integer

Alias
UMLS CUI [1]
C2347091
Diagnosis
Description

Please report medication(s) as specified in the protocol and fill in the Medication section.

Data type

text

Alias
UMLS CUI [1]
C0011900
Disease status
Description

Disease status

Data type

integer

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0449438

Similar models

Medical history/ physical examination

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (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
Visit type
integer
C0332307 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
Code List
Visit type
CL Item
Screening (all WB's) (1)
CL Item
Visit Month 6 (WB1+3) (2)
CL Item
Visit Month 12 (WB2+4) (3)
CL Item
Visit Day 21 (WB3+4) (4)
Visit Date
Item
Visit Date
date
C1320303 (UMLS CUI [1])
Item Group
Physical Examination, Medical history
C0031809 (UMLS CUI-1)
C0262926 (UMLS CUI-2)
Item
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
text
C0521987 (UMLS CUI [1])
C2347662 (UMLS CUI [2,1])
C0037088 (UMLS CUI [2,2])
Code List
Are you aware of any pre-existing conditions, signs or symptoms present prior to the start of the study?
CL Item
Yes (Y)
CL Item
No (N)
Item
MedDRA System Organ Class
integer
C2347091 (UMLS CUI [1])
Code List
MedDRA System Organ Class
CL Item
Skin and subcutaneous tissue (1)
CL Item
Musculoskeletal and connective tissue (2)
CL Item
Cardiac (3)
CL Item
Vascular (4)
CL Item
Respiratory, thoracic and mediastinal (5)
CL Item
Gastrointestinal (6)
CL Item
Hepatobiliary (7)
CL Item
Renal and urinary (8)
CL Item
Nervous system (9)
CL Item
Eye (10)
CL Item
Ear and labyrinth (11)
CL Item
Endocrine (12)
CL Item
Metabolism and nutrition (13)
CL Item
Blood and lymphatic system (14)
CL Item
Immune system (15)
CL Item
Infections and infestations (16)
CL Item
eoplasms benign, malignant and unspecified (17)
CL Item
Surgical and medical procedures (18)
CL Item
Other (99)
Diagnosis
Item
Diagnosis
text
C0011900 (UMLS CUI [1])
Item
Disease status
integer
C0012634 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Code List
Disease status
CL Item
Past (1)
CL Item
Current (2)

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial