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ID
33963
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
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- 09.01.19 09.01.19 -
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GSK group of companies
Hochgeladen am
9. Januar 2019
DOI
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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 103974
Concomitant Vaccination, Concomitant Medication, Non-Serious Adverse Events, Study Conclusion Forms
Ähnliche Modelle
Concomitant Vaccination, Concomitant Medication, Non-Serious Adverse Events, Study Conclusion Forms
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Subject Number
Item
Subject Number
integer
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
Trade / (Generic) Name
Item
Record Trade / (Generic) Name
text
Administration date
Item
Administration date
date
CL Item
Intradermal (1)
CL Item
Inhalation (2)
CL Item
Intramuscular (3)
CL Item
Intravenous (4)
CL Item
Intranasal (5)
CL Item
Parenteral (6)
CL Item
Oral (7)
CL Item
Subcutaneous (8)
CL Item
Sublingual (9)
CL Item
Transdermal (10)
CL Item
Unknown (11)
CL Item
Other (12)
If Other route, please specify
Item
If Other route, please specify
text
Have any medications/treatments been administered during study period?
Item
Have any medications/treatments been administered during study period?
boolean
Trade / Generic Name
Item
Trade / Generic Name
text
Medical Indication
Item
Medical Indication
text
Was the medication / treatment prophylactic?
Item
Was the medication / treatment prophylactic?
boolean
Total daily dose
Item
Total daily dose
text
CL Item
External (1)
CL Item
Intradermal (2)
CL Item
Inhalation (3)
CL Item
Intramuscular (4)
CL Item
Intraarticular (5)
CL Item
Intrathecal (6)
CL Item
Intravenous (7)
CL Item
Intranasal (8)
CL Item
Parenteral (9)
CL Item
Oral (10)
CL Item
Rectal (11)
CL Item
Subcutaneous (12)
CL Item
Sublingual (13)
CL Item
Transdermal (14)
CL Item
Topical (15)
CL Item
Vaginal (16)
CL Item
Unknown (17)
CL Item
Other (18)
If Other route, please specify
Item
If Other route, please specify
text
non-serious adverse events
Item
Has any non-serious adverse events occured within minimum 30 days post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
boolean
CL Item
Event 1 (1)
CL Item
Event 2 (2)
CL Item
Event 3 (3)
CL Item
Event 4 (4)
Description
Item
Description
text
Administration Site
Item
Administration Site?
boolean
CL Item
Hib-MenC vaccine (1)
CL Item
MeningitecTM vaccine (2)
CL Item
InfanrixTM-IPV vaccine (3)
CL Item
PediacelTM vaccine (4)
Non-administration site?
Item
Non-administration site?
boolean
Date Started
Item
Date the event started
date
immediate post-vaccination period (30 min)
Item
Did the event start during immediate post-vaccination period (30 min)?
boolean
Date stopped
Item
Date the event stopped?
date
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
Relationship to the investigational product?
Item
Was there any relationship to the investigational product?
boolean
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered with sequelae/Resolved with sequelae (4)
medically attended visit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medial Personnel (3)
Serious Adverse Event
Item
1. Did the subject experience any Serious Adverse Event during the study period?
boolean
SAE number
Item
Please, specify the number of SAE
integer
Status of Treatment Blind
Item
2. Was the treatment blind broken during the study?
boolean
date of treatment blind broken
Item
Complete the date for treatment blind disclosure
date
CL Item
Medical emergency requiring identification of investigational product for further treatments (1)
CL Item
Other (2)
If Other, please specify
Item
If Other, please specify
text
Elimination criteria
Item
3. Did any elimination criteria become applicable during the study?
boolean
specific elimination criteria
Item
Specify any elimination criteria applied to the subject
text
Subject withdrawal
Item
4. Was the subject withdrawn from the study?
boolean
CL Item
Serious Adverse Event (SAE) (1)
CL Item
Non-Serious Adverse Event (Non-SAE) (2)
CL Item
Protocol violation, please specify (3)
CL Item
Consent withdrawal (4)
CL Item
Migrated/moved from the study area (5)
CL Item
Lost to follow-up (6)
CL Item
Other (7)
SAE number
Item
In case of SAE, please specify the SAE number
integer
AE number
Item
In case of Non-SAE, please specify the AE number
integer
If Other, please specify
Item
If Other, please specify the reason
text
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Date of last contact
Item
Date of last contact
date
Was the subject in good condition at date of last contact?
Item
Was the subject in good condition at date of last contact?
boolean
Investigator's confirmation
Item
5. I confirm a that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below.
date
Investigator's signature
Item
Investigator's signature
text
Printed Investigator's name
Item
Printed Investigator's name
text