ID

33960

Description

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

Keywords

Versions (1)
  1. 1/9/19 1/9/19 -
Copyright Holder

GSK group of companies

Uploaded on

January 9, 2019

DOI

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License

Creative Commons BY-NC 3.0
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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974

English

Visit 4: Eligibility Check, Laboratory Test

1 forms  
Administrative data
Description

Administrative data

Visit Number
Description

Visit Number

Data type

integer

Day
Description

Day

Data type

text

Subject Number
Description

Subject Number

Data type

integer

Date of Visit
Description

Date of Visit

Data type

date

Check for Study Continuation
Description

Check for Study Continuation

Did the subject return for Visit 4?
Description

Did the subject return for Visit 4?

Data type

boolean

If No, please tick ONE most appropriate reason
Description

If No, please tick ONE most appropriate reason

Data type

text

If Other, please specify
Description

If Other, please specify

Data type

text

If SAE, record the SAE number
Description

If SAE, record the SAE number

Data type

integer

If non-SAE, please record the AE number
Description

If non-SAE, please record the AE number

Data type

integer

Please tick who took the decision
Description

Please tick who took the decision

Data type

text

Elimination Criteria During The Study
Description

Elimination Criteria During The Study

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

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.

Data type

text

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

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

Data type

text

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

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

Data type

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
Description

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

Data type

text

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

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

Data type

text

Laboratory Tests - Blood
Description

Laboratory Tests - Blood

Has a blood sample been taken?
Description

Has a blood sample been taken?

Data type

boolean

Date blood sample taken
Description

please fill in only if different from visit date

Data type

date

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Similar models

Visit 4: Eligibility Check, Laboratory Test

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Item
Visit Number
integer
Visit Number
Code List
Visit Number
CL Item
Visit 4 (1)
Item
Day
text
Day
Code List
Day
CL Item
30-42 days after Visit 3 (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 4?
Item
Did the subject return for Visit 4?
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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