ID

34739

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 form contains information about Contraindications to subsequent vaccination and should be checked at visit 1(Month 0, pre-vacc), 2(Month 1) and 3(Month 6).

Link

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

Keywords

Versions (1)
  1. 1/25/19 1/25/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

January 25, 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

Contraindications to subsequent 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
Visit number
Description

Visit number

Data type

text

Alias
UMLS CUI [1]
C1549755
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Absolute contraindications to further administration of vaccine
Description

Absolute contraindications to further administration of vaccine

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C1301624
UMLS CUI-3
C0205344
Clinically significant decreased liver or renal function which in the opinion of the investigator (or designate) preclude further administration of vaccine to the subject
Description

Clinically significant decreased liver or renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0232807
UMLS CUI [1,2]
C2985739
UMLS CUI [1,3]
C2368628
UMLS CUI [1,4]
C0683610
UMLS CUI [2,1]
C0232744
UMLS CUI [2,2]
C2985739
UMLS CUI [2,3]
C2368628
UMLS CUI [2,4]
C0683610
Any confirmed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required).
Description

Immunodeficient condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C0262926
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0332147
UMLS CUI [2,3]
C0262926
UMLS CUI [3,1]
C0021051
UMLS CUI [3,2]
C0750484
UMLS CUI [3,3]
C0031809
UMLS CUI [4,1]
C0021051
UMLS CUI [4,2]
C0332147
UMLS CUI [4,3]
C0031809
Pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
Hypersensitivity reaction following vaccine administration (including urticaria within 30 minutes of vaccine administration).
Description

Hypersensitivity reaction following vaccine administration

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2368628
UMLS CUI [2,1]
C0042109
UMLS CUI [2,2]
C2368628
Anaphylactic reaction following the administration of study/ control vaccine(s).
Description

Anaphylactic reaction following the administration of study/ control vaccine(s).

Data type

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C2368628
Any SAE judged to be related to study/ control vaccine(s)
Description

A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life threatening, results in persistent or significant disability / incapacity, requires in-patient hospitalization, prolongation of existing hospitalization or is a congenital anomaly / birth defect in the offspring of a study subject. In addition, important medical events that may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above should be considered serious. (Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization.) For each serious adverse event the investigator becomes aware of, please fill in a Serious Adverse Event (SAE) report.

Data type

boolean

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C1875384
Other significant reactions which in the opinion of the investigator (or designate) preclude further administration of the study/ control vaccine (may include severe pain, severe swelling, severe limitation of motion, persistent high fever, severe headache or other systemic or local reactions).
Description

Other significant reactions which in the opinion of the investigator (or designate) preclude further administration of the study/ control vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0683610
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C0443286
UMLS CUI [1,4]
C2985739
UMLS CUI [2]
C0278140
UMLS CUI [3,1]
C0038999
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0026597
UMLS CUI [4,2]
C0449295
UMLS CUI [4,3]
C0205082
UMLS CUI [5]
C0476474
UMLS CUI [6,1]
C0018681
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C1710276
UMLS CUI [7,2]
C0205394
UMLS CUI [8,1]
C0853813
UMLS CUI [8,2]
C0205394
Contraindications to administration of vaccine at current time
Description

Contraindications to administration of vaccine at current time

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C1301624
UMLS CUI-3
C0521116
Acute disease at the time of vaccination
Description

Acute disease is defined as the presence of a moderate or severe illness with or without fever. Enrolment will be deferred until condition is resolved. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature < 37.5 °C (99.5 °F)/axillary temperature < 37.5 °C (99.5 °F).

Data type

boolean

Alias
UMLS CUI [1,1]
C0001314
UMLS CUI [1,2]
C0150312
UMLS CUI [1,3]
C2368628
Oral/axillary temperature ≥37.5 °C (99.5 °F) at the time of vaccination
Description

Oral/axillary temperature ≥37.5 °C (99.5 °F) at the time of vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C0039476
UMLS CUI [1,2]
C0442027
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0040223
UMLS CUI [2,1]
C1531924
UMLS CUI [2,2]
C0042196
UMLS CUI [2,3]
C0040223
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Similar models

Contraindications to subsequent 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])
Item
Visit number
text
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 1(Month 0, pre-vacc) (Visit 1)
CL Item
Visit 2(Month 1) (Visit 2)
CL Item
Visit 3(Month 6) (Visit 3)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item Group
Absolute contraindications to further administration of vaccine
C2368628 (UMLS CUI-1)
C1301624 (UMLS CUI-2)
C0205344 (UMLS CUI-3)
Clinically significant decreased liver or renal function
Item
Clinically significant decreased liver or renal function which in the opinion of the investigator (or designate) preclude further administration of vaccine to the subject
boolean
C0232807 (UMLS CUI [1,1])
C2985739 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
C0683610 (UMLS CUI [1,4])
C0232744 (UMLS CUI [2,1])
C2985739 (UMLS CUI [2,2])
C2368628 (UMLS CUI [2,3])
C0683610 (UMLS CUI [2,4])
Immunodeficient condition
Item
Any confirmed or suspected immunodeficient condition based on medical history and physical examination (no laboratory testing required).
boolean
C0021051 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,3])
C0021051 (UMLS CUI [2,1])
C0332147 (UMLS CUI [2,2])
C0262926 (UMLS CUI [2,3])
C0021051 (UMLS CUI [3,1])
C0750484 (UMLS CUI [3,2])
C0031809 (UMLS CUI [3,3])
C0021051 (UMLS CUI [4,1])
C0332147 (UMLS CUI [4,2])
C0031809 (UMLS CUI [4,3])
Pregnancy
Item
Pregnancy
boolean
C0032961 (UMLS CUI [1])
Hypersensitivity reaction following vaccine administration
Item
Hypersensitivity reaction following vaccine administration (including urticaria within 30 minutes of vaccine administration).
boolean
C0020517 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0042109 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
Anaphylactic reaction following the administration of study/ control vaccine(s).
Item
Anaphylactic reaction following the administration of study/ control vaccine(s).
boolean
C0002792 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Any SAE judged to be related to study/ control vaccine(s)
Item
Any SAE judged to be related to study/ control vaccine(s)
boolean
C1519255 (UMLS CUI [1,1])
C1875384 (UMLS CUI [1,2])
Other significant reactions which in the opinion of the investigator (or designate) preclude further administration of the study/ control vaccine
Item
Other significant reactions which in the opinion of the investigator (or designate) preclude further administration of the study/ control vaccine (may include severe pain, severe swelling, severe limitation of motion, persistent high fever, severe headache or other systemic or local reactions).
boolean
C0683610 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0443286 (UMLS CUI [1,3])
C2985739 (UMLS CUI [1,4])
C0278140 (UMLS CUI [2])
C0038999 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0026597 (UMLS CUI [4,1])
C0449295 (UMLS CUI [4,2])
C0205082 (UMLS CUI [4,3])
C0476474 (UMLS CUI [5])
C0018681 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C1710276 (UMLS CUI [7,1])
C0205394 (UMLS CUI [7,2])
C0853813 (UMLS CUI [8,1])
C0205394 (UMLS CUI [8,2])
Item Group
Contraindications to administration of vaccine at current time
C2368628 (UMLS CUI-1)
C1301624 (UMLS CUI-2)
C0521116 (UMLS CUI-3)
Acute disease at the time of vaccination
Item
Acute disease at the time of vaccination
boolean
C0001314 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Oral/axillary temperature ≥37.5 °C (99.5 °F) at the time of vaccination
Item
Oral/axillary temperature ≥37.5 °C (99.5 °F) at the time of vaccination
boolean
C0039476 (UMLS CUI [1,1])
C0442027 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,4])
C1531924 (UMLS CUI [2,1])
C0042196 (UMLS CUI [2,2])
C0040223 (UMLS CUI [2,3])
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