ID

42732

Description

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 1 Study ID: 100388 Clinical Study ID: 100388 Study Title: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00226499 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Varicella Vaccine Trade Name: BIO OKAH; Varilrix Study Indication: Varicella

Keywords

Versions (2)
  1. 8/19/17 8/19/17 -
  2. 9/17/21 9/17/21 -
Copyright Holder

glaxoSmithKline

Uploaded on

September 17, 2021

DOI

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License

Creative Commons BY-NC 3.0
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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 1

English

GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 1

1 forms  
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.

Data type

date

Alias
UMLS CUI [1]
C2985782
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Center number
Description

Center number

Data type

text

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

Date of birth

Data type

date

Alias
UMLS CUI [1]
C0421451
Gender
Description

Gender

Data type

text

Alias
UMLS CUI [1]
C0079399
Race
Description

Race

Data type

text

Alias
UMLS CUI [1]
C0034510
Other Race, please specify
Description

If you chose 'Other Race', please specify

Data type

text

Alias
UMLS CUI [1,1]
C0034510
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C3845569
Eligibility check
Description

Eligibility check

Alias
UMLS CUI-1
C0013893
Did the subject meet all the entry criteria?
Description

If No, tick all boxes corresponding to violations of any inclusion/exclusion criteria. Do not enter the subject into the study if he/she failed any inclusion or exclusion criteria below.

Data type

boolean

Alias
UMLS CUI [1]
C1516637
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) for the whole duration of the study.
Description

Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1321605
Male or female subject between 12 and 22 months (including the day before the 23-month birthday) of age at the time of the first vaccination.
Description

age at first vaccination

Data type

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0042196
Subjects free of obvious health problems, as established by medical history and physical examination before entering the study.
Description

healthy subject

Data type

boolean

Alias
UMLS CUI [1]
C1708335
Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure.
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Subjects whose parents/guardians have direct access to telephone/mobile phone (either at home or at work).
Description

access to telephone

Data type

boolean

Alias
UMLS CUI [1]
C1822200
Subjects: (1) with at least one sibling (with negative history of varicella disease/vaccination) at home, or (2) attending day care center (subjects who are registered for attendance at day care center from 24 months of age may be considered for inclusion in the study), or (3) attending childminders, i.e. someone taking care of several children (with at least one child without a known positive history of varicella disease/vaccination), or (4) who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes.
Description

contact to varicella

Data type

boolean

Alias
UMLS CUI [1]
C1455968
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
Previous vaccination against measles, mumps, rubella and/or varicella.
Description

Previous vaccination against measles, mumps, rubella and/or varicella.

Data type

boolean

Alias
UMLS CUI [1]
C0042201
UMLS CUI [2]
C0042202
UMLS CUI [3]
C0042206
UMLS CUI [4]
C4302743
History of previous measles, mumps, rubella and/or varicella/zoster diseases
Description

History of previous measles, mumps, rubella and/or varicella/zoster diseases

Data type

boolean

Alias
UMLS CUI [1]
C0455465
UMLS CUI [2]
C0455466
UMLS CUI [3]
C0455467
UMLS CUI [4]
C0455469
UMLS CUI [5]
C0740380
Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
Description

exposure to measles, mumps, rubella and/or varicella/zoster

Data type

boolean

Alias
UMLS CUI [1]
C2732622
UMLS CUI [2]
C0920247
UMLS CUI [3]
C2720520
UMLS CUI [4]
C0262619
UMLS CUI [5]
C0750129
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day). Inhaled and topical steroids are allowed.
Description

Chronic administration of immunosuppressants or other immune-modifying drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0279021
Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
Description

Administration of immunoglobulins and/or any blood products

Data type

boolean

Alias
UMLS CUI [1,1]
C0021027
UMLS CUI [1,2]
C0456388
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
Description

immunosuppressive or immunodeficient condition

Data type

boolean

Alias
UMLS CUI [1,1]
C0021079
UMLS CUI [1,2]
C0021051
Family history of congenital or hereditary immunodeficiency.
Description

Family history of congenital or hereditary immunodeficiency.

Data type

boolean

Alias
UMLS CUI [1,1]
C0241889
UMLS CUI [1,2]
C0853602
UMLS CUI [2,1]
C0439660
UMLS CUI [2,2]
C0021051
History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin.
Description

History of allergic diseases or reactions

Data type

boolean

Alias
UMLS CUI [1]
C2106654
UMLS CUI [2]
C0567447
UMLS CUI [3]
C0571380
Major congenital defects or serious chronic illness.
Description

Major congenital defects or serious chronic illness.

Data type

boolean

Alias
UMLS CUI [1,1]
C0000768
UMLS CUI [1,2]
C0205164
UMLS CUI [2,1]
C0008679
UMLS CUI [2,2]
C0205404
Residence in the same household as newborns (0-4 weeks of age), pregnant mothers varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella (At any point in time when such exclusion criterion becomes not applicable, potential study participants may come back at a later stage for study inclusion)..
Description

(At any point in time when such exclusion criterion becomes not applicable, potential study participants may come back at a later stage for study inclusion)

Data type

boolean

Alias
UMLS CUI [1,1]
C0682072
UMLS CUI [1,2]
C0021051
UMLS CUI [2]
C1855205
History of any neurologic disorders or seizures.
Description

History of any neurologic disorders or seizures.

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0036572
Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period.
Description

Use of any investigational or non-registered product

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0013230
Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).
Description

Administration of a licensed vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C1960631
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C0032375
Randomisation / Treatment allocation
Description

Randomisation / Treatment allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Description

Record treatment number

Data type

integer

Alias
UMLS CUI [1,1]
C1522541
UMLS CUI [1,2]
C0600091
General medical history / physical examination
Description

General medical history / physical examination

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

Please tick appropriate box(es) and give diagnosis.

Data type

boolean

Alias
UMLS CUI [1]
C0521987
General medical history / physical examination
Description

General medical history / physical examination

Alias
UMLS CUI-1
C0262926
UMLS CUI-2
C0031809
anatomic site of symptoms
Description

anatomic site of symptoms

Data type

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0037088
Diagnosis 1
Description

diagnosis 1

Data type

text

Alias
UMLS CUI [1]
C0011900
Diagnosis 2
Description

diagnosis 2

Data type

text

Alias
UMLS CUI [1]
C0011900
Past (diagnosis)
Description

diagnosis past

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C1444637
Present (diagnosis)
Description

diagnosis present

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0150312
Laboratory tests
Description

Laboratory tests

Alias
UMLS CUI-1
C0022885
Has a blood sample been taken?
Description

Blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Date blood sample taken
Description

Please complete only if different from visit date

Data type

boolean

Alias
UMLS CUI [1,1]
C1277698
UMLS CUI [1,2]
C0011008
Category of exposure
Description

Category of exposure

Alias
UMLS CUI-1
C2220266
UMLS CUI-2
C0683312
What category of exposure did the subject fall into at Inclusion?
Description

category of exposure

Data type

integer

Alias
UMLS CUI [1,1]
C2220266
UMLS CUI [1,2]
C0683312
Vaccine administration
Description

Vaccine administration

Alias
UMLS CUI-1
C2368628
Pre-Vaccination temperature
Description

Pre-Vaccination temperature

Data type

float

Measurement units
  • degree Celsius
Alias
UMLS CUI [1]
C0005903
degree Celsius
Route
Description

anatomic site Temperature taken

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974
Vaccine administration
Description

Vaccine administration

Data type

text

Alias
UMLS CUI [1]
C2368628
Replacement vial
Description

Replacement vial

Data type

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Wrong vial number
Description

Wrong vial number

Data type

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C3827420
Has the study vaccine been administered according to the Protocol?
Description

Protocol: Side: Left Site: Upper arm (Deltoid) Route: S.C.

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0013153
Side (vaccine administered)
Description

Only answer if vaccine wasn't administered according to protocol.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0444532
UMLS CUI [1,3]
C0443246
Site (vaccine administered)
Description

Only answer if vaccine wasn't administered according to protocol.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1515974
Route (vaccine administered)
Description

Only answer if vaccine wasn't administered according to protocol.

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0013153
Comments (on vaccine administration)
Description

Comments on vaccine administration

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0947611
Date of vaccination
Description

fill in only if different from visit date

Data type

date

Alias
UMLS CUI [1]
C4301990
Why was the vaccine not administered?
Description

Please tick the ONE most appropriate category for non administration

Data type

text

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0392360
SAE No
Description

Please specify number of SAE if that is the reason, why vaccine wasn't administered.

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0449788
Please specify unsolicited AE No
Description

number of unsolicited adverse event

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Please specify 'other' most appropriate category for non administration.
Description

e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...

Data type

text

Alias
UMLS CUI [1,1]
C3840932
UMLS CUI [1,2]
C1521902
UMLS CUI [1,3]
C2368628
Unsolicited adverse event
Description

Unsolicited adverse event

Alias
UMLS CUI-1
C0877248
UMLS CUI-2
C0042196
Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
Description

non-serious unsolicited adverse event

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0231291
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0231291
Solicited adverse events - Local symptoms
Description

Solicited adverse events - Local symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
UMLS CUI-3
C0042196
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Description

If Yes is ticked, please complete all following items.

Data type

text

Alias
UMLS CUI [1,1]
C0851536
UMLS CUI [1,2]
C0037088
Redness
Description

Administration site erythema

Data type

boolean

Alias
UMLS CUI [1]
C3805283
Size (of redness at administration site) Day 0
Description

Size of erythema at administration site Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Size (of redness at administration site) Day 1
Description

Size of erythema at administration site Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Size (of redness at administration site) Day 2
Description

Size of erythema at administration site Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Size (of redness at administration site) Day 3
Description

Size of erythema at administration site Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0456389
mm
Ongoing after Day 3?
Description

Erythema ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C3805283
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0332575
UMLS CUI [1,3]
C2700396
Swelling
Description

Administration site swelling

Data type

boolean

Alias
UMLS CUI [1]
C3854415
Size (of swelling at administration site) Day 0
Description

Size of swelling at administration site Day 0

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
mm
Size (of swelling at administration site) Day 1
Description

Size of swelling at administration site Day 1

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
mm
Size (of swelling at administration site) Day 2
Description

Size of swelling at administration site Day 2

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
mm
Size (of swelling at administration site) Day 3
Description

Size of swelling at administration site Day 3

Data type

integer

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0456389
mm
Ongoing after day 3?
Description

Swelling ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C3854415
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038999
UMLS CUI [1,3]
C2700396
Pain
Description

Administration site pain

Data type

boolean

Alias
UMLS CUI [1]
C0521491
Intensity (of pain at administration site) Day 0
Description

Intensity: 0: None 1: Mild 2: Moderate 3: Severe

Data type

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Intensity (of pain at administration site) Day 1
Description

Intensity: 0: None 1: Mild 2: Moderate 3: Severe

Data type

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Intensity (of pain at administration site) Day 2
Description

Intensity: 0: None 1: Mild 2: Moderate 3: Severe

Data type

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Intensity (of pain at administration site) Day 3
Description

Intensity: 0: None 1: Mild 2: Moderate 3: Severe

Data type

integer

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C1320357
Ongoing after day 3?
Description

Pain ongoing after day 3

Data type

boolean

Alias
UMLS CUI [1,1]
C0521491
UMLS CUI [1,2]
C0549178
Date of last day of symptoms
Description

Date of last day of symptoms

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0030193
UMLS CUI [1,3]
C2700396
Solicited adverse events - General symptoms
Description

Solicited adverse events - General symptoms

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0042196
UMLS CUI-3
C0877248
Has the subject experienced any of the following signs/symptoms during 42 days post-vaccination 1?
Description

If Yes is ticked, please complete all following items.

Data type

text

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C2368628
Fever
Description

≥37.5 °C axillary/≥38.0 °C rectal route If yes, please complete the Temperature section.

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C2368628
General rash / exanthema
Description

excluding varicella / zoster If yes, please complete the Rash / Exanthema section.

Data type

boolean

Alias
UMLS CUI [1,1]
C0015230
UMLS CUI [1,2]
C2368628
Parotid / salivary gland swelling
Description

If yes, please complete the Parotid / Salivary Gland Swelling section.

Data type

boolean

Alias
UMLS CUI [1,1]
C0240925
UMLS CUI [1,2]
C2368628
Febrile convulsions – suspected signs of meningism
Description

If yes, please complete the Febrile Convulsions – Suspected Signs of Meningism section.

Data type

boolean

Alias
UMLS CUI [1,1]
C0009952
UMLS CUI [1,2]
C2368628
UMLS CUI [2,1]
C0025287
UMLS CUI [2,2]
C2368628
Varicella / zoster
Description

If yes, please complete the Varicella / Zoster section.

Data type

boolean

Alias
UMLS CUI [1,1]
C0008049
UMLS CUI [1,2]
C2368628
UMLS CUI [2,1]
C0740380
UMLS CUI [2,2]
C2368628
Temperature
Description

Temperature

Alias
UMLS CUI-1
C0039476
Route
Description

Direct measurement of axillary/ rectal temperature within 15 days post-vaccination 1. Only ONE route of temperature measurement should be used consistently for a given subject. Fever: Axillary: > 37.5°C Rectal: > 38.0°C

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974
Temperature
Description

Temperature

Alias
UMLS CUI-1
C0039476
Episode No
Description

Day 1 - 42

Data type

integer

Temperature
Description

Temperature

Data type

float

Measurement units
  • Degree Celsius
Alias
UMLS CUI [1]
C0039476
Degree Celsius
Not taken (Temperature)
Description

Temperature not taken

Data type

boolean

Alias
UMLS CUI [1]
C0039476
Causality
Description

Only fill in if fever.

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C3641099
UMLS CUI [1,3]
C2368628
Medically attended Visit?
Description

Medically attended Visit?

Data type

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C0015967
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GSK Study: Evaluation of safety and efficacy of VarilrixTM and of Combined Measles-Mumps-Rubella-Varicella Vaccine NCT00226499 - Visit 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed Consent Date
Item
Informed Consent Date
date
C2985782 (UMLS CUI [1])
Item Group
Demographics
C1704791 (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
Gender
text
C0079399 (UMLS CUI [1])
Gender
Code List
Gender
CL Item
Male (M)
CL Item
Female (F)
Item
Race
text
C0034510 (UMLS CUI [1])
Race
Code List
Race
CL Item
Black (1)
CL Item
Arabic/North African (4)
CL Item
White/Caucasian (2)
CL Item
East & South East Asian (5)
CL Item
South Asian (6)
CL Item
American Hispanic (7)
CL Item
Japanese (8)
CL Item
Other (9)
Other Race
Item
Other Race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
Item Group
Eligibility check
C0013893 (UMLS CUI-1)
meet entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (UMLS CUI [1])
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Compliance
Item
Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) for the whole duration of the study.
boolean
C2348568 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
age at first vaccination
Item
Male or female subject between 12 and 22 months (including the day before the 23-month birthday) of age at the time of the first vaccination.
boolean
C0001779 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
healthy subject
Item
Subjects free of obvious health problems, as established by medical history and physical examination before entering the study.
boolean
C1708335 (UMLS CUI [1])
Informed consent
Item
Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure.
boolean
C0021430 (UMLS CUI [1])
access to telephone
Item
Subjects whose parents/guardians have direct access to telephone/mobile phone (either at home or at work).
boolean
C1822200 (UMLS CUI [1])
contact to varicella
Item
Subjects: (1) with at least one sibling (with negative history of varicella disease/vaccination) at home, or (2) attending day care center (subjects who are registered for attendance at day care center from 24 months of age may be considered for inclusion in the study), or (3) attending childminders, i.e. someone taking care of several children (with at least one child without a known positive history of varicella disease/vaccination), or (4) who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes.
boolean
C1455968 (UMLS CUI [1])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Previous vaccination against measles, mumps, rubella and/or varicella.
Item
Previous vaccination against measles, mumps, rubella and/or varicella.
boolean
C0042201 (UMLS CUI [1])
C0042202 (UMLS CUI [2])
C0042206 (UMLS CUI [3])
C4302743 (UMLS CUI [4])
History of previous measles, mumps, rubella and/or varicella/zoster diseases
Item
History of previous measles, mumps, rubella and/or varicella/zoster diseases
boolean
C0455465 (UMLS CUI [1])
C0455466 (UMLS CUI [2])
C0455467 (UMLS CUI [3])
C0455469 (UMLS CUI [4])
C0740380 (UMLS CUI [5])
exposure to measles, mumps, rubella and/or varicella/zoster
Item
Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
boolean
C2732622 (UMLS CUI [1])
C0920247 (UMLS CUI [2])
C2720520 (UMLS CUI [3])
C0262619 (UMLS CUI [4])
C0750129 (UMLS CUI [5])
Chronic administration of immunosuppressants or other immune-modifying drugs
Item
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥ 0.5 mg/kg/day). Inhaled and topical steroids are allowed.
boolean
C0021081 (UMLS CUI [1,1])
C0279021 (UMLS CUI [1,2])
Administration of immunoglobulins and/or any blood products
Item
Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1,1])
C0456388 (UMLS CUI [1,2])
immunosuppressive or immunodeficient condition
Item
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
boolean
C0021079 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
Family history of congenital or hereditary immunodeficiency.
Item
Family history of congenital or hereditary immunodeficiency.
boolean
C0241889 (UMLS CUI [1,1])
C0853602 (UMLS CUI [1,2])
C0439660 (UMLS CUI [2,1])
C0021051 (UMLS CUI [2,2])
History of allergic diseases or reactions
Item
History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin.
boolean
C2106654 (UMLS CUI [1])
C0567447 (UMLS CUI [2])
C0571380 (UMLS CUI [3])
Major congenital defects or serious chronic illness.
Item
Major congenital defects or serious chronic illness.
boolean
C0000768 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0008679 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
persons with a known immunodeficiency or any other persons at high risk for varicella
Item
Residence in the same household as newborns (0-4 weeks of age), pregnant mothers varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella (At any point in time when such exclusion criterion becomes not applicable, potential study participants may come back at a later stage for study inclusion)..
boolean
C0682072 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C1855205 (UMLS CUI [2])
History of any neurologic disorders or seizures.
Item
History of any neurologic disorders or seizures.
boolean
C0027765 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
Use of any investigational or non-registered product
Item
Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period.
boolean
C1524063 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Administration of a licensed vaccine
Item
Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).
boolean
C1960631 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C0032375 (UMLS CUI [1,3])
Item Group
Randomisation / Treatment allocation
C0034656 (UMLS CUI-1)
Record treatment number
Item
Record treatment number
integer
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
Item Group
General medical history / physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
pre-existing conditions
Item
Are you aware of any pre-existing conditions or signs and/or symptoms present in the subject prior to the start of the study?
boolean
C0521987 (UMLS CUI [1])
Item Group
General medical history / physical examination
C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)
Item
anatomic site of symptoms
integer
C1515974 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
anatomic site of symptoms
Code List
anatomic site of symptoms
CL Item
Cutaneous (10)
CL Item
Eyes (5)
CL Item
Ears-Nose-Throat (6)
CL Item
Cardiovascular (2)
CL Item
Respiratory (3)
CL Item
Gastrointestinal (1)
CL Item
Muskuloskeletal (7)
CL Item
Neurological (8)
CL Item
Genitourinary (12)
CL Item
Haematology (11)
CL Item
Allergies (4)
CL Item
Endocrine (9)
CL Item
Other (specify) (99)
diagnosis 1
Item
Diagnosis 1
text
C0011900 (UMLS CUI [1])
diagnosis 2
Item
Diagnosis 2
text
C0011900 (UMLS CUI [1])
diagnosis past
Item
Past (diagnosis)
boolean
C0011900 (UMLS CUI [1,1])
C1444637 (UMLS CUI [1,2])
diagnosis present
Item
Present (diagnosis)
boolean
C0011900 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
Item Group
Laboratory tests
C0022885 (UMLS CUI-1)
Blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date blood sample taken
Item
Date blood sample taken
boolean
C1277698 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Category of exposure
C2220266 (UMLS CUI-1)
C0683312 (UMLS CUI-2)
Item
What category of exposure did the subject fall into at Inclusion?
integer
C2220266 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
category of exposure
Code List
What category of exposure did the subject fall into at Inclusion?
CL Item
At least one sibling (with negative history of varicella disease/vaccination) at home (1)
CL Item
Attending day care center (subjects who are registered for attendance at day care center from (2)
CL Item
Who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes. (4)
CL Item
Attending childminders, i.e. someone taking care of several children (with at least one child without a known positive history of varicella disease/vaccination), (3)
CL Item
Who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes. (4)
Item Group
Vaccine administration
C2368628 (UMLS CUI-1)
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1])
Item
Route
text
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
anatomic site Temperature taken
Code List
Route
CL Item
Axillary (A)
CL Item
Rectal (R)
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
Vaccine administration
Code List
Vaccine administration
CL Item
Study Vaccine (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial
Item
Replacement vial
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number
Item
Wrong vial number
text
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
vaccine administered according to protocol
Item
Has the study vaccine been administered according to the Protocol?
boolean
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0013153 (UMLS CUI [1,3])
Item
Side (vaccine administered)
text
C2368628 (UMLS CUI [1,1])
C0444532 (UMLS CUI [1,2])
C0443246 (UMLS CUI [1,3])
Side (vaccine administered)
Code List
Side (vaccine administered)
CL Item
Right (R)
CL Item
Left (L)
Item
Site (vaccine administered)
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Site (vaccine administered)
Code List
Site (vaccine administered)
CL Item
Thigh (3)
CL Item
Buttock (6)
CL Item
Upper arm (Deltoid) (10)
CL Item
Lower arm (11)
Item
Route (vaccine administered)
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Route (vaccine administered)
Code List
Route (vaccine administered)
CL Item
i.m. (IM)
CL Item
s.c. (SC)
Comments on vaccine administration
Item
Comments (on vaccine administration)
text
C2368628 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Date of vaccination
Item
Date of vaccination
date
C4301990 (UMLS CUI [1])
Item
Why was the vaccine not administered?
text
C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Why was the vaccine not administered?
Code List
Why was the vaccine not administered?
CL Item
Serious adverse event (complete the Serious Adverse Event form) (SAE)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section) (AEX)
CL Item
Other, please specify (e.g.: consent withdrawal, protocol violation, non-serious AE for non-subset...) (OTH)
Number of serious adverse event
Item
SAE No
integer
C1519255 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
number of unsolicited adverse event
Item
Please specify unsolicited AE No
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
specify other reason
Item
Please specify 'other' most appropriate category for non administration.
text
C3840932 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Item Group
Unsolicited adverse event
C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
Item
Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
text
C1519255 (UMLS CUI [1,1])
C0231291 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0231291 (UMLS CUI [2,2])
non-serious unsolicited adverse event
Code List
Has the subject experienced any serious or non-serious unsolicited adverse events within 42 days post-vaccination 1?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, fill in the Non-Serious Adverse Event (for subset only) pages or Serious Adverse Event form. (Y)
Item Group
Solicited adverse events - Local symptoms
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
C0851536 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
signs or symptoms at administration site
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (U)
CL Item
No vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Administration site erythema
Item
Redness
boolean
C3805283 (UMLS CUI [1])
Size of erythema at administration site Day 0
Item
Size (of redness at administration site) Day 0
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 1
Item
Size (of redness at administration site) Day 1
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 2
Item
Size (of redness at administration site) Day 2
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of erythema at administration site Day 3
Item
Size (of redness at administration site) Day 3
integer
C3805283 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Erythema ongoing after day 3
Item
Ongoing after Day 3?
boolean
C3805283 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Administration site swelling
Item
Swelling
boolean
C3854415 (UMLS CUI [1])
Size of swelling at administration site Day 0
Item
Size (of swelling at administration site) Day 0
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 1
Item
Size (of swelling at administration site) Day 1
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 2
Item
Size (of swelling at administration site) Day 2
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Size of swelling at administration site Day 3
Item
Size (of swelling at administration site) Day 3
integer
C3854415 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Swelling ongoing after day 3
Item
Ongoing after day 3?
boolean
C3854415 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Administration site pain
Item
Pain
boolean
C0521491 (UMLS CUI [1])
Intensity of pain at administration site Day 0
Item
Intensity (of pain at administration site) Day 0
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 1
Item
Intensity (of pain at administration site) Day 1
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 2
Item
Intensity (of pain at administration site) Day 2
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Intensity of pain at administration site Day 3
Item
Intensity (of pain at administration site) Day 3
integer
C0521491 (UMLS CUI [1,1])
C1320357 (UMLS CUI [1,2])
Pain ongoing after day 3
Item
Ongoing after day 3?
boolean
C0521491 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Date of last day of symptoms
Item
Date of last day of symptoms
date
C0011008 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Item Group
Solicited adverse events - General symptoms
C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)
Item
Has the subject experienced any of the following signs/symptoms during 42 days post-vaccination 1?
text
C0037088 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
undefined item
Code List
Has the subject experienced any of the following signs/symptoms during 42 days post-vaccination 1?
CL Item
Information not available (U)
CL Item
No Vaccine administered (NA)
CL Item
No (N)
CL Item
Yes, please tick No/Yes for each symptom. If Yes is ticked, please complete all items. (Y)
Fever after vaccine administration
Item
Fever
boolean
C0015967 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
General rash / exanthema after vaccine administration
Item
General rash / exanthema
boolean
C0015230 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
salivary gland swelling
Item
Parotid / salivary gland swelling
boolean
C0240925 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Febrile convulsions or suspected signs of meningism after vaccine administration
Item
Febrile convulsions – suspected signs of meningism
boolean
C0009952 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0025287 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
Varicella or Varicella zoster after vaccine administration
Item
Varicella / zoster
boolean
C0008049 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C0740380 (UMLS CUI [2,1])
C2368628 (UMLS CUI [2,2])
Item Group
Temperature
C0039476 (UMLS CUI-1)
Item
Route
text
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
temperature route
Code List
Route
CL Item
Axillary (A)
CL Item
Rectal (R)
Item Group
Temperature
C0039476 (UMLS CUI-1)
Episode No
Item
Episode No
integer
Temperature
Item
Temperature
float
C0039476 (UMLS CUI [1])
Temperature not taken
Item
Not taken (Temperature)
boolean
C0039476 (UMLS CUI [1])
Causality with vaccination fever
Item
Causality
boolean
C0015967 (UMLS CUI [1,1])
C3641099 (UMLS CUI [1,2])
C2368628 (UMLS CUI [1,3])
Medically attended Visit?
Item
Medically attended Visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C0015967 (UMLS CUI [1,3])
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