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ID
33959
Beschrijving
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
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Versies (1)
- 09-01-19 09-01-19 -
Houder van rechten
GSK group of companies
Geüploaded op
9 januari 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974
Visit 3: Vaccine Administration, Eligibility Criteria, Symptoms, Adverse Events Forms
Similar models
Visit 3: Vaccine Administration, Eligibility Criteria, Symptoms, Adverse Events Forms
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
CL Item
Visit 3 (1)
CL Item
28-42 days after Visit 2 (1)
CL Item
Dose 3 (1)
Subject Number
Item
Subject Number
integer
Date of Visit
Item
Date of Visit
date
Did the subject return for Visit 3?
Item
Did the subject return for Visit 3?
boolean
Item
If No, please tick ONE most appropriate reason
text
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
CL Item
Investigator (1)
CL Item
Parents / Guardians (2)
Item
The following criteria should be checked at each visit subsequent to the first visit.
text
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
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
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
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
Code List
4. Administration of immunoglobulins and/or any blood products during the study period
CL Item
Applicable (1)
CL Item
Not applicable (2)
Date
Item
Date
date
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
CL Item
Axillary (1)
CL Item
Rectal (2)
CL Item
Hib-MenC Vaccine (1)
CL Item
MeningitecTM Vaccine (2)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered -> please complete following section (5)
If replacement vial, please record the number
Item
If replacement vial, please record the number
integer
If wrong vial, please record the number
Item
If wrong vial, please record the number
integer
CL Item
Right (1)
CL Item
Thigh (1)
CL Item
I.M. (1)
Has the study vaccine been administered according to the Protocol?
Item
Has the study vaccine been administered according to the Protocol?
boolean
CL Item
Left (1)
CL Item
Right (2)
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
CL Item
I.M. (1)
CL Item
S.C. (2)
CL Item
InfanrixTM-IPV Vaccine (1)
CL Item
PediacelTM Vaccine (2)
CL Item
Replacement vial (3)
CL Item
Wrong vial number (4)
CL Item
Not administered -> please complete following section (5)
If Replacement vial, please record the number
Item
If Replacement vial, please record the number
integer
If Wrong vial number, please record the number
Item
If Wrong vial number, please record the number
integer
CL Item
Left (1)
CL Item
Thigh (1)
CL Item
I.M. (1)
Has the study vaccine been administered according to protocol?
Item
Has the study vaccine been administered according to protocol?
boolean
CL Item
Left (1)
CL Item
Right (2)
CL Item
Deltoid (1)
CL Item
Thigh (2)
CL Item
Buttock (3)
CL Item
I.M. (1)
CL Item
S.C. (2)
Item
If vaccine not administered, choose ONE most appropriate reason
text
Code List
If vaccine not administered, choose 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
Has the subject experienced any serious or non-serious unsolicited adverse events within one month (minimum 30 days) post-vaccination?
text
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 (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form (4)
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
If Redness, record size
Item
If Redness, record size
float
If Swelling, record size
Item
If Swelling, record size
float
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Medically attended visit?
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Solicited Adverse Events - Local Symptoms - Vaccine 2
CL Item
Redness (1)
CL Item
Swelling (2)
CL Item
Pain (3)
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
If Redness, record size
Item
If Redness, record size
float
If Swelling, record size
Item
If Swelling, record size
float
CL Item
none (1)
CL Item
mild (2)
CL Item
moderate (3)
CL Item
severe (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
boolean
medically attended visit?
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes (4)
CL Item
Fever (1)
CL Item
Irritability/Fussiness (2)
CL Item
Drowsiness (3)
CL Item
Loss of appetite (4)
If Fever, record t°
Item
If Fever, record t°
float
CL Item
none (1)
CL Item
mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Item
If Irritability / Fussiness, record intensity
text
Code List
If Irritability / Fussiness, record intensity
CL Item
none (1)
CL Item
mild (2)
CL Item
moderate (3)
CL Item
severe (4)
CL Item
none (1)
CL Item
mild (2)
CL Item
moderate (3)
CL Item
severe (4)
CL Item
None (1)
CL Item
Mild (2)
CL Item
moderate (3)
CL Item
severe (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit?
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)