Informações:
Falhas:
ID
38671
Descrição
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
Palavras-chave
Versões (2)
- 11/01/2019 11/01/2019 -
- 30/10/2019 30/10/2019 - Sarah Riepenhausen
Titular dos direitos
GSK group of companies
Transferido a
30 de outubro de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Primary & Booster Immunogenicity of Hib-MenC vs a Licensed Men-C Vaccine - 104056
Miscellaneous Forms: Temperature Log, Adverse Events, Rash, Gland Swelling, Febrile Convulsions, Concomitant Medication
Similar models
Miscellaneous Forms: Temperature Log, Adverse Events, Rash, Gland Swelling, Febrile Convulsions, Concomitant Medication
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Subject Number
Item
Subject Number
integer
Body Temperature Episode Number
Item
Episode Number
integer
temperature taken?
Item
Was temperature taken?
text
Day of Fever event
Item
Please record the day of fever/temperature event
text
CL Item
Axillary (1)
CL Item
Rectal (2)
Temperature
Item
Temperature
float
If fever
Item
If the event matches the definition of fever, please record whether is was connected to the investigational product
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)
If antipyretics or antibiotics -> Medication form
Item
If any antipyretics or antibiotics has been taken, please complete the Concomitant Medication section.
text
If FeverAfterSolicitedPeriod
Item
If fever occurs after the solicited period, please complete the Non-Serious Adverse Event sections.
text
RashExanthema
Item
Has any rash / exanthem event occurred?
boolean
Rash Episode Number
Item
Rash Episode Number
integer
Description
Item
Description
text
Item
Did rash occur at administration site of vaccine or non-administration site?
text
Code List
Did rash occur at administration site of vaccine or non-administration site?
CL Item
Administration site (1)
CL Item
Non-administration site (2)
CL Item
Hib-MenC vaccine (1)
CL Item
Priorix vaccine (2)
Item
If non-administration site, please record the site
text
Code List
If non-administration site, please record the site
CL Item
Generalized (1)
CL Item
Localized (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
CL Item
1-50 lesions (1)
CL Item
51 - 150 lesions (2)
CL Item
> 150 lesions (3)
Relationship to investigational product
Item
Is there a reasonable possibility that the AE may have been caused by 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)
medicallyAttendedVisit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Episode Number
Item
Episode Number
integer
Description
Item
Description
text
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
CL Item
Swelling without difficulties to move the jaw (1)
CL Item
Swelling with difficulties to move the jaw (2)
CL Item
Swelling and additional general symptoms (3)
Saliva sample
Item
Was saliva sample taken for mumps virus detection, strain identification and for viral culture?
boolean
Date sample taken
Item
Date sample taken
date
Causality
Item
Is there a reasonable possibility that the AE hay have been caused by 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)
MedicallyAttendedVisit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Febrile Convulsions - Suspected Signs of Meningitis
Episode Number
Item
Episode Number
integer
Description
Item
Description
text
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
NeurologicalExamination
Item
Was a neurological examination performed?
boolean
LumbarPuncturePerformed?
Item
If Yes, was a lumbar puncture performed?
boolean
MedRepostofLumbarPuncure
Item
If Yes, please attach a copy of Medical Report
text
Causality
Item
Is there a reasonable possibility that the AE hay have been caused by 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)
MedicallyAttendedVisit
Item
Was the visit medically attended?
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
ConcomitantVaccinationQuestion
Item
Have any other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
Trade/Generic Name
Item
Trade/Generic Name
text
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)
Administration Date
Item
Administration Date
date
concomitant medications / treatments
Item
Have any medications / treatments been administered during the study period?
boolean
Trade/Genereic Name
Item
Trade/Genereic Name
text
ProphylacticAdministration
Item
Was the administration prophylactic?
boolean
Medical Indication
Item
Medical Indication
text
Total daily dose
Item
Total daily dose
text
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
Vaginal (11)
CL Item
Unknown (12)
CL Item
Other (13)
If Other, please specify
Item
If Other, please specify
text
Start Date
Item
Start Date
date
End Date
Item
End Date
date
Ongoing?
Item
Is the event continuing?
boolean
AnyNon-SeriousAE
Item
Has any non-serious adverse events occurred within minimum 30 days post-vaccination, excluding those recorded on the Solicited Adverse Events forms?
boolean
Episode Number
Item
Episode Number
integer
Description
Item
Description
text
CL Item
administrationsite (1)
CL Item
non-administration site (2)
CL Item
Hib-MenC vaccine (1)
CL Item
Priorix vaccine (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
CL Item
mild (1)
CL Item
moderate (2)
CL Item
severe (3)
RelationshipToInvestigationalProducts
Item
Is there a reasonable possibility that the AE may have been caused by 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
Medically attended visit
boolean
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)