ID

27217

Beschreibung

Study ID: 103533 Clinical Study ID: 103533 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal CRF Seiten: 599-679 & 1063-1112

Link

http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Stichworte

Versionen (1)
  1. 03.11.17 03.11.17 -
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Pfizer

Hochgeladen am

3. November 2017

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Meningococcal Infections Vaccination in children NCT00196976

Englisch

Workbook 2 Visit 1 Part 1

1 Formulare  
Administrative Documentation
Beschreibung

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Alias
UMLS CUI [1]
C1320303
Informed consent
Beschreibung

Informed consent

Alias
UMLS CUI-1
C0021430
I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date:
Beschreibung

Informed consent

Datentyp

date

Alias
UMLS CUI [1]
C0021430
Demographics
Beschreibung

Demographics

Alias
UMLS CUI-1
C1704791
Center Number
Beschreibung

Center Number

Datentyp

integer

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

Date of birth

Datentyp

date

Alias
UMLS CUI [1]
C0421451
Gender
Beschreibung

Gender

Datentyp

text

Alias
UMLS CUI [1]
C0079399
Race
Beschreibung

Race

Datentyp

text

Alias
UMLS CUI [1]
C0034510
Eligibility Check
Beschreibung

Eligibility Check

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

Eligibility Check

Datentyp

boolean

Alias
UMLS CUI [1]
C0013893
Inclusion criteria Tick the boxes corresponding to any of the inclusion criteria the subject failed
Beschreibung

Inclusion criteria Tick the boxes corresponding to any of the inclusion criteria the subject failed

Alias
UMLS CUI-1
C1512693
UMLS CUI-2
C1516637
[ 1 ] Subjects who 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) should be enrolled in the study.
Beschreibung

Patient Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0023226
[ 2 ] A male or female between, and including, 12 and 14 months or 3 and 5 years (36 to 60 months) of age at the time of the first vaccination
Beschreibung

Age at first vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0042196
[ 3 ] Written informed consent obtained from the the parent or guardian of the subject.
Beschreibung

Written informed consent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0023226
[ 4 ] Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Beschreibung

Health Problems

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1446390
UMLS CUI [1,2]
C0332296
[ 5 ] Previously completed routine childhood vaccinations to the best of his/her parents’/guardians’ knowledge. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.
Beschreibung

childhood vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0205156
UMLS CUI [1,2]
C0231335
UMLS CUI [1,3]
C0042196
UMLS CUI [1,4]
C0205197
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
[ 6 ] Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Beschreibung

Use of investigational new drug

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1524063
[ 7 ] 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, x 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
Beschreibung

Immunosuppressants | Immune-modifying drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
[ 8 ] Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine (OPV)
Beschreibung

Other vaccine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
[ 9 ] Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
Beschreibung

Meningococcal vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C0700144
UMLS CUI [1,3]
C0776552
UMLS CUI [1,4]
C1444655
[ 10 ] Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
Beschreibung

H. influenza type B Vaccine | Diphteria vaccine | Tetanus vaccine

Datentyp

boolean

Alias
UMLS CUI [1]
C0062082
UMLS CUI [2,1]
C0012546
UMLS CUI [2,2]
C0042210
UMLS CUI [3]
C0305062
[ 11 ] For subjects aged 12-14 months at enrolment: - For Austria: DTPa-HBV-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2. - For Greece: DTPa-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2.
Beschreibung

Booster vaccination

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020975
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C0205448
[ 12 ] History of meningococcal serogroup A, C, W-135 or Y disease.
Beschreibung

Disease history

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0683519
UMLS CUI [1,2]
C1135745
UMLS CUI [2,1]
C0683519
UMLS CUI [2,2]
C1135746
UMLS CUI [3,1]
C0683519
UMLS CUI [3,2]
C1135747
UMLS CUI [4,1]
C0683519
UMLS CUI [4,2]
C1136209
UMLS CUI [5,1]
C0683519
UMLS CUI [5,2]
C1136210
[ 13 ] Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year.
Beschreibung

Disease exposure

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1135745
UMLS CUI [2,1]
C0332157
UMLS CUI [2,2]
C1135746
UMLS CUI [3,1]
C0332157
UMLS CUI [3,2]
C1135747
UMLS CUI [4,1]
C0332157
UMLS CUI [4,2]
C1136209
UMLS CUI [5,1]
C0332157
UMLS CUI [5,2]
C1136210
[ 14 ] Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Beschreibung

Immunosuppresive condition | immunodeficient condition

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3829792
UMLS CUI [1,2]
C0021051
UMLS CUI [1,3]
C0019693
[ 15 ] A family history of congenital or hereditary immunodeficiency.
Beschreibung

Immunodeficiency

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021051
UMLS CUI [1,2]
C0853602
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C0439660
[ 16 ] History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Beschreibung

allergic reactions

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2106654
UMLS CUI [1,3]
C0042210
UMLS CUI [1,4]
C1705248
[ 17 ] Major congenital defects or serious chronic illness.
Beschreibung

Congenital defects | Serious chronic illness

Datentyp

boolean

Alias
UMLS CUI [1]
C0008679
UMLS CUI [2,1]
C0220810
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C0008679
UMLS CUI [2,4]
C0205404
[ 18 ] History of any neurologic disorders or seizures.
Beschreibung

Neurological disorders

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C0036572
[ 19 ] > Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. 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. Axillary temperature <37.5°C / Rectal temperature <38°C)
Beschreibung

Acute disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0001314
[ 20 ] Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Beschreibung

Immunoglobulins | Blood products

Datentyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0371802
Randomisation/ Treatment Allocation
Beschreibung

Randomisation/ Treatment Allocation

Alias
UMLS CUI-1
C0034656
Record treatment number
Beschreibung

Treatment Number

Datentyp

integer

Alias
UMLS CUI [1]
C1522541
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Ähnliche Modelle

Workbook 2 Visit 1 Part 1

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date of Visit
Item
Date of Visit
date
C1320303 (UMLS CUI [1])
Item Group
Informed consent
C0021430 (UMLS CUI-1)
Informed consent
Item
I certify that Informed Consent has been obtained prior to any study procedure. Informed Consent Date:
date
C0021430 (UMLS CUI [1])
Item Group
Demographics
C1704791 (UMLS CUI-1)
Center Number
Item
Center Number
integer
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
Blck (1)
CL Item
White Caucasian (2)
CL Item
Arabic/North African (4)
CL Item
East & South East Asian (5)
CL Item
South Asian (6)
CL Item
American Hispanic (7)
CL Item
Japanese (8)
CL Item
Other, please specify (9)
Item Group
Eligibility Check
C0013893 (UMLS CUI-1)
Eligibility Check
Item
Did the subject meet all the entry criteria ? 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.
boolean
C0013893 (UMLS CUI [1])
Item Group
Inclusion criteria Tick the boxes corresponding to any of the inclusion criteria the subject failed
C1512693 (UMLS CUI-1)
C1516637 (UMLS CUI-2)
Patient Compliance
Item
[ 1 ] Subjects who 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) should be enrolled in the study.
boolean
C1321605 (UMLS CUI [1,1])
C0023226 (UMLS CUI [1,2])
Age at first vaccination
Item
[ 2 ] A male or female between, and including, 12 and 14 months or 3 and 5 years (36 to 60 months) of age at the time of the first vaccination
boolean
C0001779 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Written informed consent
Item
[ 3 ] Written informed consent obtained from the the parent or guardian of the subject.
boolean
C0021430 (UMLS CUI [1,1])
C0023226 (UMLS CUI [1,2])
Health Problems
Item
[ 4 ] Free of obvious health problems as established by medical history and clinical examination before entering into the study.
boolean
C1446390 (UMLS CUI [1,1])
C0332296 (UMLS CUI [1,2])
childhood vaccination
Item
[ 5 ] Previously completed routine childhood vaccinations to the best of his/her parents’/guardians’ knowledge. For pertussis vaccination, the children aged 12-14 months should have been vaccinated with an acellular pertussis vaccine.
boolean
C0205156 (UMLS CUI [1,1])
C0231335 (UMLS CUI [1,2])
C0042196 (UMLS CUI [1,3])
C0205197 (UMLS CUI [1,4])
Item Group
Exclusion Criteria
C0680251 (UMLS CUI-1)
Use of investigational new drug
Item
[ 6 ] Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Immunosuppressants | Immune-modifying drugs
Item
[ 7 ] 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, x 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0005525 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Other vaccine
Item
[ 8 ] Planned administration/ administration of a vaccine not foreseen by the study protocol within one month of the first dose of vaccine and up to one month after administration of each study vaccine dose with the exception of oral polio vaccine (OPV)
boolean
C2368628 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Meningococcal vaccination
Item
[ 9 ] Previous vaccination against meningococcal serogroup A, C, W-135 or Y disease.
boolean
C2368628 (UMLS CUI [1,1])
C0700144 (UMLS CUI [1,2])
C0776552 (UMLS CUI [1,3])
C1444655 (UMLS CUI [1,4])
H. influenza type B Vaccine | Diphteria vaccine | Tetanus vaccine
Item
[ 10 ] Administration of a H. influenzae type b, diphtheria or tetanus vaccine within 3 months before the first dose of vaccine.
boolean
C0062082 (UMLS CUI [1])
C0012546 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0305062 (UMLS CUI [3])
Booster vaccination
Item
[ 11 ] For subjects aged 12-14 months at enrolment: - For Austria: DTPa-HBV-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2. - For Greece: DTPa-IPV/Hib booster vaccination in the second year of life: these booster vaccines will be given at Visit 2.
boolean
C0020975 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C0205448 (UMLS CUI [1,3])
Disease history
Item
[ 12 ] History of meningococcal serogroup A, C, W-135 or Y disease.
boolean
C0683519 (UMLS CUI [1,1])
C1135745 (UMLS CUI [1,2])
C0683519 (UMLS CUI [2,1])
C1135746 (UMLS CUI [2,2])
C0683519 (UMLS CUI [3,1])
C1135747 (UMLS CUI [3,2])
C0683519 (UMLS CUI [4,1])
C1136209 (UMLS CUI [4,2])
C0683519 (UMLS CUI [5,1])
C1136210 (UMLS CUI [5,2])
Disease exposure
Item
[ 13 ] Known exposure to meningococcal serogroup A, C, W-135 or Y disease within the previous year.
boolean
C0332157 (UMLS CUI [1,1])
C1135745 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C1135746 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C1135747 (UMLS CUI [3,2])
C0332157 (UMLS CUI [4,1])
C1136209 (UMLS CUI [4,2])
C0332157 (UMLS CUI [5,1])
C1136210 (UMLS CUI [5,2])
Immunosuppresive condition | immunodeficient condition
Item
[ 14 ] Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C3829792 (UMLS CUI [1,1])
C0021051 (UMLS CUI [1,2])
C0019693 (UMLS CUI [1,3])
Immunodeficiency
Item
[ 15 ] A family history of congenital or hereditary immunodeficiency.
boolean
C0021051 (UMLS CUI [1,1])
C0853602 (UMLS CUI [1,2])
C0021051 (UMLS CUI [2,1])
C0439660 (UMLS CUI [2,2])
allergic reactions
Item
[ 16 ] History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
boolean
C0020517 (UMLS CUI [1,1])
C2106654 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
Congenital defects | Serious chronic illness
Item
[ 17 ] Major congenital defects or serious chronic illness.
boolean
C0008679 (UMLS CUI [1])
C0220810 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C0008679 (UMLS CUI [2,3])
C0205404 (UMLS CUI [2,4])
Neurological disorders
Item
[ 18 ] History of any neurologic disorders or seizures.
boolean
C0027765 (UMLS CUI [1,1])
C0036572 (UMLS CUI [1,2])
Acute disease
Item
[ 19 ] > Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. 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. Axillary temperature <37.5°C / Rectal temperature <38°C)
boolean
C0001314 (UMLS CUI [1])
Immunoglobulins | Blood products
Item
[ 20 ] Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
boolean
C0021027 (UMLS CUI [1])
C0371802 (UMLS CUI [2])
Item Group
Randomisation/ Treatment Allocation
C0034656 (UMLS CUI-1)
Treatment Number
Item
Record treatment number
integer
C1522541 (UMLS CUI [1])
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