ID

34016

Beschreibung

Study ID: 103974 (primary study) Clinical Study ID: 103974 Study Title: Demonstrate non-inferiority of Men-C immune response of Hib-MenC with Infanrix™-IPV versus a licensed Men-C vaccine with Pediacel™ when given at 2, 3, 4 months and the immunogenicity of Hib-MenC when given as a booster dose at 12-15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00258700 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENC-TT; Menitorix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Stichworte

Versionen (1)
  1. 11.01.19 11.01.19 -
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GSK group of companies

Hochgeladen am

11. Januar 2019

DOI

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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974

Englisch

Visit 6: Eligibility Check, Laboratory Test

1 Formulare  
Administrative data
Beschreibung

Administrative data

Visit Number
Beschreibung

Visit Number

Datentyp

integer

Day
Beschreibung

Day

Datentyp

text

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Date of Visit
Beschreibung

Date of Visit

Datentyp

date

Check for Study Continuation
Beschreibung

Check for Study Continuation

Did the subject return for Visit 6?
Beschreibung

Did the subject return for Visit 6?

Datentyp

boolean

If No, please tick ONE most appropriate reason
Beschreibung

If No, please tick ONE most appropriate reason

Datentyp

text

If Other, please specify
Beschreibung

If Other, please specify

Datentyp

text

If SAE, record the SAE number
Beschreibung

If SAE, record the SAE number

Datentyp

integer

If non-SAE, please record the AE number
Beschreibung

If non-SAE, please record the AE number

Datentyp

integer

Please tick who took the decision
Beschreibung

Please tick who took the decision

Datentyp

text

Elimination Criteria During The Study
Beschreibung

Elimination Criteria During The Study

The following criteria should be checked at each visit subsequent to the first visit.
Beschreibung

If any of the criteria become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis.

Datentyp

text

1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
Beschreibung

1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period

Datentyp

text

2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
Beschreibung

2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.

Datentyp

text

3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after
Beschreibung

3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after

Datentyp

text

4. Administration of immunoglobulins and/or any blood products during the study period
Beschreibung

4. Administration of immunoglobulins and/or any blood products during the study period

Datentyp

text

Laboratory Tests - Blood
Beschreibung

Laboratory Tests - Blood

Has a blood sample been taken?
Beschreibung

Has a blood sample been taken?

Datentyp

boolean

Date blood sample taken
Beschreibung

please fill in only if different from visit date

Datentyp

date

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Ähnliche Modelle

Visit 6: Eligibility Check, Laboratory Test

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative data
Item
Visit Number
integer
Visit Number
Code List
Visit Number
CL Item
Visit 6 (1)
Item
Day
text
Day
Code List
Day
CL Item
42-56 days after Visit 5 (1)
Subject Number
Item
Subject Number
integer
Date of Visit
Item
Date of Visit
date
Item Group
Check for Study Continuation
Did the subject return for Visit 6?
Item
Did the subject return for Visit 6?
boolean
Item
If No, please tick ONE most appropriate reason
text
If No, please tick ONE most appropriate reason
Code List
If No, please tick ONE most appropriate reason
CL Item
Serious Adverse Event (SAE) (1)
CL Item
Non-Serious Adverse Event (Non-SAE) (2)
CL Item
Other (e.g.withdrawal,protocol violation) (3)
If Other, please specify
Item
If Other, please specify
text
If SAE, record the SAE number
Item
If SAE, record the SAE number
integer
If non-SAE, please record the AE number
Item
If non-SAE, please record the AE number
integer
Item
Please tick who took the decision
text
Please tick who took the decision
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Parents / Guardians (2)
Item Group
Elimination Criteria During The Study
Item
The following criteria should be checked at each visit subsequent to the first visit.
text
The following criteria should be checked at each visit subsequent to the first visit.
Code List
The following criteria should be checked at each visit subsequent to the first visit.
CL Item
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period (1)
CL Item
Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed.) (2)
Item
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
text
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
Code List
1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
CL Item
Applicable (1)
CL Item
Not applicable (2)
Item
2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
text
2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
Code List
2. Chronic administration (defined as more than 14 days) or immunodepressants or other imminodefying drugs during the study period.
CL Item
Applicable (1)
CL Item
Not applicable (2)
Item
3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after
text
3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after
Code List
3. Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after
CL Item
Applicable (1)
CL Item
Not applicable (2)
Item
4. Administration of immunoglobulins and/or any blood products during the study period
text
4. Administration of immunoglobulins and/or any blood products during the study period
Code List
4. Administration of immunoglobulins and/or any blood products during the study period
CL Item
Applicable (1)
CL Item
Not applicable (2)
Item Group
Laboratory Tests - Blood
Has a blood sample been taken?
Item
Has a blood sample been taken?
boolean
Date blood sample taken
Item
Date blood sample taken
date
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