ID

38671

Descrizione

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

  1. 11/01/19 11/01/19 -
  2. 30/10/19 30/10/19 - Sarah Riepenhausen
Titolare del copyright

GSK group of companies

Caricato su

30 ottobre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY-NC 3.0

Commenti del modello :

Puoi commentare il modello dati qui. Tramite i fumetti nei gruppi di articoli e articoli è possibile aggiungere commenti a quelli in modo specifico.

Commenti del gruppo di articoli per :

Commenti dell'articolo per :

Per scaricare i modelli di dati devi essere registrato. Per favore accesso o registrati GRATIS.

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

Administrative data
Descrizione

Administrative data

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Temperature Log
Descrizione

Temperature Log

Episode Number
Descrizione

Please record all temperatures within 15 days post-vaccination; Definistion of Fever: Axillary (preferrably ) ≥ 37.5 °C, Rectal ≥ 38°C

Tipo di dati

integer

Was temperature taken?
Descrizione

temperature taken?

Tipo di dati

text

Please record the day of fever/temperature event
Descrizione

Day of Fever event

Tipo di dati

text

Type of measurement
Descrizione

Type of measurementBodyTemperature

Tipo di dati

text

Temperature
Descrizione

Temperature

Tipo di dati

float

Unità di misura
  • °C
°C
If the event matches the definition of fever, please record whether is was connected to the investigational product
Descrizione

If fever

Tipo di dati

boolean

Was the visit medically attended?
Descrizione

medically attended visit

Tipo di dati

boolean

If yes, record the type of medical involvement
Descrizione

medical involvement

Tipo di dati

text

Reminder
Descrizione

Reminder

If any antipyretics or antibiotics has been taken, please complete the Concomitant Medication section.
Descrizione

If antipyretics or antibiotics -> Medication form

Tipo di dati

text

If fever occurs after the solicited period, please complete the Non-Serious Adverse Event sections.
Descrizione

If FeverAfterSolicitedPeriod

Tipo di dati

text

Rash / Exanthem
Descrizione

Rash / Exanthem

Has any rash / exanthem event occurred?
Descrizione

In case rash/exanthem is (are) observed, the parents/guardians are instructed to bring the child for a visit to investigator for complete clinical examination, further assessments and/or appropriate treatment

Tipo di dati

boolean

Rash Event Log
Descrizione

Rash Event Log

Rash Episode Number
Descrizione

Rash Episode Number

Tipo di dati

integer

Description
Descrizione

Description

Tipo di dati

text

Did rash occur at administration site of vaccine or non-administration site?
Descrizione

Administration Site

Tipo di dati

text

If administration site, please record the vaccine
Descrizione

AdministrationSiteVaccine

Tipo di dati

text

If non-administration site, please record the site
Descrizione

If non-administration site, please record the site

Tipo di dati

text

Date started
Descrizione

Date started

Tipo di dati

date

Date stopped
Descrizione

Date stopped

Tipo di dati

date

Rash intensity
Descrizione

Rash intensity

Tipo di dati

text

Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descrizione

Relationship to investigational product

Tipo di dati

boolean

Outcome
Descrizione

Outcome

Tipo di dati

text

Was the visit medically attended?
Descrizione

medicallyAttendedVisit

Tipo di dati

boolean

Please specify the type:
Descrizione

TypeMedicalAttendance

Tipo di dati

text

Parotid/Salivary Gland Swelling Events
Descrizione

Parotid/Salivary Gland Swelling Events

Episode Number
Descrizione

Episode Number

Tipo di dati

integer

Description
Descrizione

Description

Tipo di dati

text

Date started
Descrizione

Date started

Tipo di dati

date

Date stopped
Descrizione

Date stopped

Tipo di dati

date

Intensity
Descrizione

Intensity

Tipo di dati

integer

Was saliva sample taken for mumps virus detection, strain identification and for viral culture?
Descrizione

Saliva sample

Tipo di dati

boolean

Date sample taken
Descrizione

Date sample taken

Tipo di dati

date

Is there a reasonable possibility that the AE hay have been caused by the investigational product?
Descrizione

Causality

Tipo di dati

boolean

Outcome
Descrizione

Outcome

Tipo di dati

integer

Was the visit medically attended?
Descrizione

MedicallyAttendedVisit

Tipo di dati

boolean

Please specify the type:
Descrizione

MedAttendanceType

Tipo di dati

text

Febrile Convulsions - Suspected Signs of Meningitis
Descrizione

Febrile Convulsions - Suspected Signs of Meningitis

Episode Number
Descrizione

Episode Number

Tipo di dati

integer

Description
Descrizione

Description

Tipo di dati

text

Date started
Descrizione

Date started

Tipo di dati

date

Date stopped
Descrizione

Date stopped

Tipo di dati

date

Intensity
Descrizione

Intensity

Tipo di dati

integer

Was a neurological examination performed?
Descrizione

NeurologicalExamination

Tipo di dati

boolean

If Yes, was a lumbar puncture performed?
Descrizione

LumbarPuncturePerformed?

Tipo di dati

boolean

If Yes, please attach a copy of Medical Report
Descrizione

MedRepostofLumbarPuncure

Tipo di dati

text

Is there a reasonable possibility that the AE hay have been caused by the investigational product?
Descrizione

Causality

Tipo di dati

boolean

Outcome
Descrizione

Outcome

Tipo di dati

text

Was the visit medically attended?
Descrizione

MedicallyAttendedVisit

Tipo di dati

boolean

Please specify the type:
Descrizione

MedAttendanceType

Tipo di dati

text

Concomitant Vaccination
Descrizione

Concomitant Vaccination

Have any other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Descrizione

ConcomitantVaccinationQuestion

Tipo di dati

boolean

Concomitant Vaccination Details
Descrizione

Concomitant Vaccination Details

Trade/Generic Name
Descrizione

Trade/Generic Name

Tipo di dati

text

Route
Descrizione

Route

Tipo di dati

integer

Administration Date
Descrizione

Administration Date

Tipo di dati

date

Concomitant Medications
Descrizione

Concomitant Medications

Have any medications / treatments been administered during the study period?
Descrizione

concomitant medications / treatments

Tipo di dati

boolean

Concomitant Medications Details
Descrizione

Concomitant Medications Details

Trade/Genereic Name
Descrizione

Trade/Genereic Name

Tipo di dati

text

Was the administration prophylactic?
Descrizione

ProphylacticAdministration

Tipo di dati

boolean

Medical Indication
Descrizione

Medical Indication

Tipo di dati

text

Total daily dose
Descrizione

Total daily dose

Tipo di dati

text

Route
Descrizione

Route

Tipo di dati

integer

If Other, please specify
Descrizione

If Other, please specify

Tipo di dati

text

Start Date
Descrizione

Start Date

Tipo di dati

date

End Date
Descrizione

End Date

Tipo di dati

date

Is the event continuing?
Descrizione

Ongoing?

Tipo di dati

boolean

Non-Serious Adverse Events
Descrizione

Non-Serious Adverse Events

Has any non-serious adverse events occurred within minimum 30 days post-vaccination, excluding those recorded on the Solicited Adverse Events forms?
Descrizione

AnyNon-SeriousAE

Tipo di dati

boolean

Non-Serious Adverse Events Log
Descrizione

Non-Serious Adverse Events Log

Episode Number
Descrizione

Episode Number

Tipo di dati

integer

Description
Descrizione

Description

Tipo di dati

text

Was the Adverse Event at the administration site?
Descrizione

AdministrationSite

Tipo di dati

text

Please record the vaccine
Descrizione

vaccine

Tipo di dati

text

Date started
Descrizione

Date started

Tipo di dati

date

Date stopped
Descrizione

Date stopped

Tipo di dati

date

Intensity
Descrizione

Intensity

Tipo di dati

text

Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descrizione

RelationshipToInvestigationalProducts

Tipo di dati

boolean

Outcome
Descrizione

Outcome

Tipo di dati

text

Medically attended visit
Descrizione

Medically attended visit

Tipo di dati

boolean

If Yes, please specify type
Descrizione

MedAttendanceType

Tipo di dati

text

Similar models

Miscellaneous Forms: Temperature Log, Adverse Events, Rash, Gland Swelling, Febrile Convulsions, Concomitant Medication

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Temperature Log
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
Item
Type of measurement
text
Code List
Type of measurement
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
Item
If yes, record the type of medical involvement
text
Code List
If yes, record the type of medical involvement
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Reminder
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
Item Group
Rash / Exanthem
RashExanthema
Item
Has any rash / exanthem event occurred?
boolean
Item Group
Rash Event Log
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)
Item
If administration site, please record the vaccine
text
Code List
If administration site, please record the vaccine
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
Item
Rash intensity
text
Code List
Rash intensity
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
Item
Outcome
text
Code List
Outcome
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
Item
Please specify the type:
text
Code List
Please specify the type:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Parotid/Salivary Gland Swelling Events
Episode Number
Item
Episode Number
integer
Description
Item
Description
text
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
integer
Code List
Intensity
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
Item
Outcome
integer
Code List
Outcome
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
Item
Please specify the type:
text
Code List
Please specify the type:
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
Item
Intensity
integer
Code List
Intensity
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
Item
Outcome
text
Code List
Outcome
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
Item
Please specify the type:
text
Code List
Please specify the type:
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)
Item Group
Concomitant Vaccination
ConcomitantVaccinationQuestion
Item
Have any other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
boolean
Item Group
Concomitant Vaccination Details
Trade/Generic Name
Item
Trade/Generic Name
text
Item
Route
integer
Code List
Route
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
Item Group
Concomitant Medications
concomitant medications / treatments
Item
Have any medications / treatments been administered during the study period?
boolean
Item Group
Concomitant Medications Details
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
Item
Route
integer
Code List
Route
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
Item Group
Non-Serious Adverse Events
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
Item Group
Non-Serious Adverse Events Log
Episode Number
Item
Episode Number
integer
Description
Item
Description
text
Item
Was the Adverse Event at the administration site?
text
Code List
Was the Adverse Event at the administration site?
CL Item
administrationsite (1)
CL Item
non-administration site (2)
Item
Please record the vaccine
text
Code List
Please record the vaccine
CL Item
Hib-MenC vaccine (1)
CL Item
Priorix vaccine (2)
Date started
Item
Date started
date
Date stopped
Item
Date stopped
date
Item
Intensity
text
Code List
Intensity
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
Item
Outcome
text
Code List
Outcome
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
Item
If Yes, please specify type
text
Code List
If Yes, please specify type
CL Item
Hospitalization (1)
CL Item
Emergency Room (2)
CL Item
Medical Personnel (3)

Si prega di utilizzare questo modulo per feedback, domande e suggerimenti per miglioramenti.

I campi contrassegnati da * sono obbligatori.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial