ID

27342

Description

Study ID: 103534 Clinical Study ID: 103534 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 GSK’s Clinical Study Register is no longer maintained for this study.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 Booster Vaccination Only for subjects who are part of the group with the selected MenACWY-TT formulation and the control group.) “Subjects enrolled at 3 – 5 years of age” Previous study : 103533 (MenACWY-TT-010) Same subject number as previous study

Link

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

Keywords

Versions (1)
  1. 11/8/17 11/8/17 -
Copyright Holder

Pfizer

Uploaded on

November 8, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Meningococcal Infections Vaccination in children NCT00196976

English

Workbook 2 Visit 3 Part 1

1 forms  
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Date of Visit
Description

Date of Visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Eliminiation Criteria during the study
Description

Eliminiation Criteria during the study

Alias
UMLS CUI-1
C0680251
[ A ] Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
Description

Use of investigational new drug

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C1524063
[ B ] 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.)
Description

Immunosuppressants | Immune-modifying drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0021081
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C0005525
UMLS CUI [2,2]
C0205191
[ C ] Administration of a meningococcal vaccine not planned by the protocol during the whole study period.
Description

Meningococcal vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C0700144
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
[ D ] Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.
Description

Other vaccine

Data type

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C1444655
UMLS CUI [1,3]
C2348563
[ E ] Administration of immunoglobulins and/or any blood products during the study period.
Description

Immunoglobulins | Blood products

Data type

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0371802
Demographics
Description

Demographics

Alias
UMLS CUI-1
C1704791
Center Number
Description

Center Number

Data type

integer

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
Serious Adverse Events
Description

Serious Adverse Events

Alias
UMLS CUI-1
C1519255
Has the subject had any serious adverse event since the end of the primary phase and before the start of this booster vaccination ?
Description

Serious adverse Event

Data type

boolean

Alias
UMLS CUI [1]
C1519255
Specify number of SAE’s : Check SAE form(s) have been submitted to GSK Biologicals.
Description

Number of SAE

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
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Similar models

Workbook 2 Visit 3 Part 1

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
Eliminiation Criteria during the study
C0680251 (UMLS CUI-1)
Use of investigational new drug
Item
[ A ] Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period.
boolean
C0013230 (UMLS CUI [1,1])
C1524063 (UMLS CUI [1,2])
Immunosuppressants | Immune-modifying drugs
Item
[ B ] 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])
Meningococcal vaccine
Item
[ C ] Administration of a meningococcal vaccine not planned by the protocol during the whole study period.
boolean
C0700144 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Other vaccine
Item
[ D ] Administration of a vaccine not foreseen by the study protocol during the period starting from one month before each dose of vaccine(s) and ending 30 days after, with the exception of OPV.
boolean
C2368628 (UMLS CUI [1,1])
C1444655 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Immunoglobulins | Blood products
Item
[ E ] Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1])
C0371802 (UMLS CUI [2])
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 Group
Serious Adverse Events
C1519255 (UMLS CUI-1)
Serious adverse Event
Item
Has the subject had any serious adverse event since the end of the primary phase and before the start of this booster vaccination ?
boolean
C1519255 (UMLS CUI [1])
Number of SAE
Item
Specify number of SAE’s : Check SAE form(s) have been submitted to GSK Biologicals.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
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