ID

27339

Descrizione

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 GSK’s Clinical Study Register is no longer maintained for this study.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 Booster Vaccination (Only for subjects who are part of the group with the selected MenACWY-TT formulation and the control group.) “Subjects enrolled at 12 – 14 months of age”

collegamento

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

Keywords

Menigokokkenvakzine

Signs and Symptoms

Clinical Trial, Phase II

Adverse event

D014611

08/11/17 08/11/17 -
08/11/17 08/11/17 -

Titolare del copyright

Pfizer

Caricato su

8 novembre 2017

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0

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Meningococcal Infections Vaccination in children NCT00196976

model
Dettagli

Workbook 1 Visit 4 Vaccination

1 moduli

StudyEvent: ODM
1. Workbook 1 Visit 4 Vaccination

Name

genere

Description | Question | Decode (Coded Value)

Tipo di dati

Alias

Administrative Documentation

Item Group

Administrative Documentation

C1320722 (UMLS CUI-1)

Subject Number

Item

Subject Number

integer

C2348585 (UMLS CUI [1])

VACCINE ADMINISTRATION

Item Group

VACCINE ADMINISTRATION

C2368628 (UMLS CUI-1)

Date of vaccination

Item

Date (fill in only if different from visit date) :

date

C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])

temperature

Item

Pre-Vaccination temperature:

float

C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])

Route of Measurement

Item

Pre-Vaccination temperature: Route:

text

C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0449687 (UMLS CUI [1,3])

Route of Measurement

Code List

Pre-Vaccination temperature: Route:

CL Item

Axillary (A)

CL Item

Rectal (R)

Vaccine Administration

Item

Vaccine Administration (only one box must be ticked by vaccine)

text

C2368628 (UMLS CUI [1])

Vaccine Administration

Code List

Vaccine Administration (only one box must be ticked by vaccine)

CL Item

MENCEVAX™ ACWY (1/5) Vaccine (S)

CL Item

Replacement vial (R)

CL Item

Wrong vial number (W)

CL Item

Not administered, please complete below (*) (N)

Reason Vaccine not administered

Item

(*) Why not administered ? Please tick the ONE most appropriate category for non administration :

text

C2368628 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])

Reason Vaccine not administered

Code List

(*) Why not administered ? Please tick the ONE most appropriate category for non administration :

CL Item

Serious adverse event (complete the Serious Adverse Event form) Please specify SAE N° (SAE)

CL Item

Non-Serious adverse event (complete the Non-serious Adverse Event section) Please specify unsolicited AE N° or Solicited AE code (AEX)

CL Item

Other, please specify (OTH)

Decision

Item

Please tick who made the decision

text

C0679006 (UMLS CUI [1])

Decision

Code List

Please tick who made the decision

CL Item

Investigator (I)

CL Item

Parents/Guardians (P)

undefined item

Item

Side / Site Route: Left Deltoid I.M.

text

Vaccine administration

Item

Has the study vaccine been administered according to the Protocol?

boolean

C2368628 (UMLS CUI [1])

Vaccine administration Side

Item

Side

text

C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Vaccine administration Side

Code List

Side

CL Item

Left (L)

CL Item

Right (R)

Vaccine administration site

Item

Site

integer

C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])

Vaccine administration site

Code List

Site

CL Item

Deltoid (1)

CL Item

Thigh (3)

CL Item

Buttock (6)

Vaccine administration route

Item

Route

text

C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])

Vaccine administration route

Code List

Route

CL Item

I.M. (M)

CL Item

S.C. (SC)

Post vaccination observation

Item

IMMEDIATE POST-VACCINATION OBSERVATION If any adverse events occurred during the immediate post-vaccination time (30 minutes) please fill in the Solicited Adverse Events section, the Non-Serious Adverse Event section or a Serious Adverse Event form. If any prophylactic medication has been administered in anticipation of study vaccine reaction, please complete the Medication section and tick prophylactic box. Any other vaccines administered during the study period must be recorded in the Concomitant Vaccination section

text

C1443955 (UMLS CUI [1,1])
C0700325 (UMLS CUI [1,2])

Unsolicited adverse events

Item Group

Unsolicited adverse events

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

Unsolicited Adverse event

Item

Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?

text

C1519255 (UMLS CUI [1,1])
C0231291 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0231291 (UMLS CUI [2,2])

Unsolicited Adverse event

Code List

Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination ?

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 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)
C0877248 (UMLS CUI-4)

Symptoms | Signs

Item

Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?

text

C0037088 (UMLS CUI [1])

Symptoms | Signs

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

Not 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)

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS

Item Group

SOLICITED ADVERSE EVENTS – LOCAL SYMPTOMS

C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
C0042196 (UMLS CUI-3)
C0877248 (UMLS CUI-4)

Redness

Item

Redness

boolean

C0332575 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])

Size of redness

Item

Redness, size (mm) Day 0

float

C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Size of Redness

Item

Redness, size (mm) Day 1

float

C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Size of Redness

Item

Redness, size (mm) Day 2

float

C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Size of Redness

Item

Redness, size (mm) Day 3

float

C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Size of Redness

Item

Redness, size (mm) Day 4

float

C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Size of Redness

Item

Redness, size (mm) Day 5

float

C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Size of Redness

Item

Redness, size (mm) Day 6

float

C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Size of Redness

Item

Redness, size (mm) Day 7

float

C0456389 (UMLS CUI [1,1])
C0332575 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])

Ongoing symptom

Item

Ongoing redness after day 7?

boolean

C1457887 (UMLS CUI [1,1])
C3174772 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,4])

Date

Item

Date of last day of symptoms

date

C0011008 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332575 (UMLS CUI [1,3])
C2700396 (UMLS CUI [1,4])

Medically attended visit

Item

Medically attended visit

boolean

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])

Medically attended visit

Item

Medicall attended visit

text

C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])

Medically attended visit

Code List

Medicall attended visit

CL Item

Hospitalisation (HO)

CL Item

Emergency Room (ER)

CL Item

Medical personell (MD)

Swelling

Item

Swelling (SW)

boolean

C0038999 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])

Swelling

Item

Swelling, size (mm) Day 0

float