ID

34843

Description

Study ID: 104951 Clinical Study ID: 104951 Study Title: A Phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0_ 1_ 6 month schedule in healthy female subjects aged 10 - 14 years. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00290277 https://clinicaltrials.gov/ct2/show/NCT00290277 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: HPV-16/18 L1/AS04 Vaccine Trade Name: N/A Study Indication: Infections, Papillomavirus This forms contains information about concomitant medication/vaccination. Record any concomitant medication/vaccination, including any medication administered prophylactically in anticipation of reaction to the vaccination (analgesic, antipyretic). This section about concomitant medication/vaccination must be checked for final assessment at the end of the study.

Link

https://clinicaltrials.gov/ct2/show/NCT00290277

Keywords

Versions (2)
  1. 1/31/19 1/31/19 -
  2. 1/31/19 1/31/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 31, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Evaluation of immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine in healthy females NCT00290277

English

Pre-vaccination Tests and Vaccination

1 forms  
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit number
Description

The items have to be filled in at visit 1, 2 and 3

Data type

text

Alias
UMLS CUI [1]
C1549755
Pre-vaccination pregnancy test
Description

Pre-vaccination pregnancy test

Alias
UMLS CUI-1
C0032976
UMLS CUI-2
C0042196
UMLS CUI-3
C0332152
Date of urine sample taking
Description

Please complete only if different from visit date.

Data type

date

Alias
UMLS CUI [1,1]
C0200354
UMLS CUI [1,2]
C0011008
HCG urine pregnancy test: Has a urine sample been taken?
Description

If YES, please complete date of sample taking (if different from visit date) and result. If NO, please postpone vaccination until pregnancy is excluded by HCG.

Data type

boolean

Alias
UMLS CUI [1,1]
C0430056
UMLS CUI [1,2]
C0200354
Result of HCG urine pregnancy test
Description

Subjects must have a negative pregnancy test.

Data type

text

Alias
UMLS CUI [1,1]
C0427777
UMLS CUI [1,2]
C0430056
Pre-vaccination temperature
Description

Pre-vaccination temperature

Alias
UMLS CUI-1
C0005903
UMLS CUI-2
C0042196
UMLS CUI-3
C0332152
Date of temperature measurement
Description

Fill in only if different from visit date.

Data type

date

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0011008
Pre-vaccination temperature
Description

Oral/axillary temperature ≥ 37.5 °C (99.5 °F) at the time of vaccination is a contraindication to administration of study/ control vaccine at that point in time. The subject may be vaccinated at a later date or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event.

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Route of temperature measurement
Description

Rectal measurement ist not recommended.

Data type

text

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Vaccine administration
Description

Vaccine administration

Alias
UMLS CUI-1
C2368628
Date of vaccine administration
Description

Date of vaccine administration

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0011008
Vaccine administration
Description

Only one box must be ticked by vaccine. If HAV vaccine was administered and correct vial number is existent, tick '2' and note vial number below. If HAV vaccine was administered and wrong vial number is existent, tick '3' and note vial number below. If no vaccine was administered, tick '4' and complete itemgroup 'Why was the vaccine not administered?' below.

Data type

text

Alias
UMLS CUI [1]
C2368628
Has the study vaccine been administered according to the Protocol?
Description

If NO, specify Side, Site and Route in itemgroup 'Administration not according to protocol' below

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
Why was no vaccine administered?
Description

Why was no vaccine administered?

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0566251
Please tick the major reason for non administration.
Description

If you ticked '1', please complete and submit SAE report and note SAE number below. If you ticked '2', please complete Non-Serious Adverese event section and note AE number below. If you ticked '3', please specify below.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205164
SAE number
Description

Number of Serious adverese event. Fill in, if you ticked 'SAE' as major reason for non administration above.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE number
Description

Number of Non-Serious adverese event. Fill in, if you ticked 'AEX' as major reason for non administration above.

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Specify 'Other' for non administration.
Description

Fill in, if you ticked 'Other' as major reson for non administration above. (e.g.: consent withdrawal, Protocol violation, ..

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C0205394
Tick, who made the decision not to administrate the vaccine
Description

Who made the decision not administrate the vaccine?

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0679006
Administration not according to protocol
Description

Administration not according to protocol

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C1705236
Side of vaccination
Description

This item has to be filled in only if the vaccine was not administered according to protocol.

Data type

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0441987
Site of vaccination
Description

This item has to be filled in only if the vaccine was not administered according to protocol.

Data type

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1515974
Route of vaccination
Description

This item has to be filled in only if the vaccine was not administered according to protocol.

Data type

text

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0013153
Immediate Post-Vaccination Observation
Description

Immediate Post-Vaccination Observation

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C0700325
Did the subject experience any urticaria / rash within 30 minutes after the vaccine administration?
Description

Did the subject experience any urticaria / rash within 30 minutes after the vaccine administration?

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0042109
UMLS CUI [2,1]
C2368628
UMLS CUI [2,2]
C0015230
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Similar models

Pre-vaccination Tests and Vaccination

1 forms
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])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit number
text
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 1 (month 0) (Visit 1)
CL Item
Visit 2 (month 1) (Visit 2)
CL Item
Visit 3 (month 6) (Visit 3)
Item Group
Pre-vaccination pregnancy test
C0032976 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Date of urine sample taking
Item
Date of urine sample taking
date
C0200354 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
HCG urine pregnancy test
Item
HCG urine pregnancy test: Has a urine sample been taken?
boolean
C0430056 (UMLS CUI [1,1])
C0200354 (UMLS CUI [1,2])
Item
Result of HCG urine pregnancy test
text
C0427777 (UMLS CUI [1,1])
C0430056 (UMLS CUI [1,2])
Result of HCG urine pregnancy test
Code List
Result of HCG urine pregnancy test
CL Item
Negative (Negative)
CL Item
Positive (Positive)
Item Group
Pre-vaccination temperature
C0005903 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0332152 (UMLS CUI-3)
Date of temperature measurement
Item
Date of temperature measurement
date
C0005903 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Pre-vaccination temperature
Item
Pre-vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Route of temperature measurement
text
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Route of temperature measurement
Code List
Route of temperature measurement
CL Item
Axillary (Axillary)
CL Item
Oral (Oral)
CL Item
Rectal (Rectal)
Item Group
Vaccine administration
C2368628 (UMLS CUI-1)
Date of vaccine administration
Item
Date of vaccine administration
text
C2368628 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
HPV 16/18 VLP Vaccine (HPV) (1)
CL Item
Hepatitis A (HAV) Vaccine  (2)
CL Item
Hepatitis A (HAV) Vaccine (Wrong vial number existent) (3)
CL Item
Not administered (4)
Administration of study vaccine according to protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Item Group
Why was no vaccine administered?
C2368628 (UMLS CUI-1)
C0566251 (UMLS CUI-2)
Item
Please tick the major reason for non administration.
text
C2368628 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205164 (UMLS CUI [1,3])
Major reason for non administration
Code List
Please tick the major reason for non administration.
CL Item
Serious adverse event (SAE) (1)
CL Item
Non-Serious adverese event (AEX) (2)
CL Item
Other (3)
SAE number
Item
SAE number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE number
Item
AE number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Specify 'Other' reason for non administration
Item
Specify 'Other' for non administration.
text
C2368628 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Tick, who made the decision not to administrate the vaccine
text
C2368628 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
Who made the decision not administrate the vaccine?
Code List
Tick, who made the decision not to administrate the vaccine
CL Item
Investigator (1)
CL Item
Subject or Parents / Legally Acceptable Representative(s) (2)
Item Group
Administration not according to protocol
C2368628 (UMLS CUI-1)
C1705236 (UMLS CUI-2)
Item
Side of vaccination
text
C0042210 (UMLS CUI [1,1])
C0441987 (UMLS CUI [1,2])
Side of vaccination
Code List
Side of vaccination
CL Item
Dominant (D)
CL Item
Non-dominant (N)
Item
Site of vaccination
text
C0042210 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Site of vaccination
Code List
Site of vaccination
CL Item
Deltoid (1)
CL Item
Thigh (3)
CL Item
Buttock (6)
Item
Route of vaccination
text
C0042210 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Route of vaccination
Code List
Route of vaccination
CL Item
I.M. (IM)
CL Item
S.C. (SC)
Item Group
Immediate Post-Vaccination Observation
C0042196 (UMLS CUI-1)
C0700325 (UMLS CUI-2)
Did the subject experience any urticaria / rash within 30 minutes after the vaccine administration?
Item
Did the subject experience any urticaria / rash within 30 minutes after the vaccine administration?
boolean
C2368628 (UMLS CUI [1,1])
C0042109 (UMLS CUI [1,2])
C2368628 (UMLS CUI [2,1])
C0015230 (UMLS CUI [2,2])
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