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])
Item
Race
text
C0034510 (UMLS CUI [1])
CL Item
Arabic/North African (4)
CL Item
White/Caucasian (2)
CL Item
East & South East Asian (5)
CL Item
American Hispanic (7)
Other Race
Item
Other Race, please specify
text
C0034510 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
meet entry criteria
Item
Did the subject meet all the entry criteria?
boolean
C1516637 (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])
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])
Record treatment number
Item
Record treatment number
integer
C1522541 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
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
anatomic site of symptoms
integer
C1515974 (UMLS CUI [1,1])
C0037088 (UMLS CUI [1,2])
Code List
anatomic site of symptoms
CL Item
Ears-Nose-Throat (6)
CL Item
Cardiovascular (2)
CL Item
Gastrointestinal (1)
CL Item
Muskuloskeletal (7)
CL Item
Genitourinary (12)
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])
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
What category of exposure did the subject fall into at Inclusion?
integer
C2220266 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
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)
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])
Item
Vaccine administration
text
C2368628 (UMLS CUI [1])
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])
Code List
Side (vaccine administered)
Item
Site (vaccine administered)
text
C2368628 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Code List
Site (vaccine administered)
CL Item
Upper arm (Deltoid) (10)
Item
Route (vaccine administered)
text
C2368628 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
Code List
Route (vaccine administered)
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])
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
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])
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
Yes, fill in the Non-Serious Adverse Event (for subset only) pages or Serious Adverse Event form. (Y)
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])
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
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
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])
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
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
Route
text
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
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])