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42732

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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

Trefwoorden

D019433

Adverse event

Eligibility Determination

Medical History Taking

Masernvakzine

D009108

Rubella Vaccine

19-08-17 19-08-17 -
17-09-21 17-09-21 -

Houder van rechten

glaxoSmithKline

Geüploaded op

17 september 2021

DOI

Voor een aanvraag inloggen.

Licentie

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

model
Details

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

1 Formulieren

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

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Informed consent

Item Group

Informed consent

C0021430 (UMLS CUI-1)

Informed Consent Date

Item

Informed Consent Date

date

C2985782 (UMLS CUI [1])

Demographics

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])

Gender

Item

Gender

text

C0079399 (UMLS CUI [1])

Gender

Code List

Gender

CL Item

Male (M)

CL Item

Female (F)

Race

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])

Eligibility

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])

Inclusion criteria

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])

Exclusion Criteria

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])

Randomisation / Treatment allocation

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])

General medical history / physical examination

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])

General medical history / physical examination

Item Group

General medical history / physical examination

C0262926 (UMLS CUI-1)
C0031809 (UMLS CUI-2)

anatomic site of symptoms

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])

Laboratory tests

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])

Category of exposure

Item Group

Category of exposure

C2220266 (UMLS CUI-1)
C0683312 (UMLS CUI-2)

category of exposure

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)

Vaccine administration

Item Group

Vaccine administration

C2368628 (UMLS CUI-1)

Pre-Vaccination temperature

Item

Pre-Vaccination temperature

float

C0005903 (UMLS CUI [1])

anatomic site Temperature taken

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)

Vaccine administration

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])

Side (vaccine administered)

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)

Site (vaccine administered)

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)

Route (vaccine administered)

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])

Why was the vaccine not administered?

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])

Unsolicited adverse event

Item Group

Unsolicited adverse event

C0877248 (UMLS CUI-1)
C0042196 (UMLS CUI-2)

non-serious unsolicited adverse event

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)

Solicited adverse events - Local symptoms

Item Group

Solicited adverse events - Local symptoms

C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)

signs or symptoms at administration site

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])

Solicited adverse events - General symptoms

Item Group

Solicited adverse events - General symptoms

C1457887 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0877248 (UMLS CUI-3)

Signs and symptoms post-vaccination

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])

Temperature

Item Group

Temperature

C0039476 (UMLS CUI-1)

temperature route

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)

Temperature

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

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

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