ID

23093

Descrizione

Study ID: 100551 (EXT Y11) Clinical Study ID: 100551 Study Title: A double blind randomised, comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B vaccine when administered in healthy adults Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00289770 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis A (Inactivated), Hepatitis B (Recombinant) Vaccine Trade Name: Twinrix Study Indication: Hepatitis A; Hepatitis B

Keywords

versioni (3)
  1. 2017-06-23 2017-06-23 -
  2. 2017-06-23 2017-06-23 -
  3. 2017-09-25 2017-09-25 -
Caricato su

23 juni 2017

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.

Torna ai commenti del modello
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.

Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 23 Year 15)

Inglese

Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 23 Year 15)

1 moduli  
General Information
Descrizione

General Information

Subject number
Descrizione

Subject number

Tipo di dati

integer

Did the subject return for follow-up concerning the additional vaccination visit?
Descrizione

Check for study continuation

Tipo di dati

text

Please tick the ONE most appropriate reason and skip the following pages of this visit.
Descrizione

To be completet only for subject receiving additional vaccination

Tipo di dati

text

If Other reason, please specify
Descrizione

Specification of other reason

Tipo di dati

text

Please tick who took the decision
Descrizione

Who took the decision?

Tipo di dati

text

Laboratory tests
Descrizione

Laboratory tests

Date of visit
Descrizione

Date of visit

Tipo di dati

date

Subject number
Descrizione

Subject number

Tipo di dati

integer

Has a blood sample been taken?
Descrizione

Blood sample

Tipo di dati

text

Date blood sample was taken
Descrizione

Date blood sample was taken

Tipo di dati

date

Additional / Concomitant Vaccination
Descrizione

Additional / Concomitant Vaccination

Has any vaccine other than the study vaccine(s) been administered one starting 30 days prior to the vaccone dose and ending one month (minimum 30 days) after the vaccine dose?
Descrizione

To be completed only for subject receiving additional vaccination.

Tipo di dati

text

Specification of concomitant Vaccination
Descrizione

Specification of concomitant Vaccination

Trade / (Generic) Name
Descrizione

Trade / (Generic) Name

Tipo di dati

text

Route
Descrizione

ID = Intradermal PE = Parenteral IH = Inhalation PO = Oral IM = Intramuscular SC = Subcutaneous IV = Intravenous SL = Sublingual NA = Intranasal TD = Transdermal OTH = Other UNK = Unknown

Tipo di dati

text

Administration date
Descrizione

Administration date

Tipo di dati

date

Additional Vaccination / Medication
Descrizione

Additional Vaccination / Medication

Subject Number
Descrizione

Subject Number

Tipo di dati

integer

Have any medications/treatments been administered starting 30 days prior to the vaccine dose and ending one month (minimum 30 days) after the vaccine dose?
Descrizione

Medication

Tipo di dati

text

Specification of additional Vaccination / Medication
Descrizione

Specification of additional Vaccination / Medication

Trade / Generic name
Descrizione

Trade / Generic name

Tipo di dati

text

Medical Indication
Descrizione

Medical Indication

Tipo di dati

text

Prophylactic
Descrizione

Prophylactic

Tipo di dati

boolean

Total daily dose
Descrizione

Total daily dose

Tipo di dati

float

Route
Descrizione

Route

Tipo di dati

text

Start date
Descrizione

Start date

Tipo di dati

date

End date
Descrizione

End date

Tipo di dati

date

Continuing at the end of study?
Descrizione

Continuing at the end of study?

Tipo di dati

boolean

Ritorna all'inizio della pagina

Similar models

Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 23 Year 15)

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
General Information
Subject number
Item
Subject number
integer
Item
Did the subject return for follow-up concerning the additional vaccination visit?
text
Check for study continuation
Code List
Did the subject return for follow-up concerning the additional vaccination visit?
CL Item
yes -> Please complete the next pages (1)
CL Item
No -> Please complete below. (2)
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
text
Most appropriate reason not to return for follow-up
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse event (complete the Serious Adverse Event form) (1)
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event section)  (2)
CL Item
Other, please specify. (3)
Specification of other reason
Item
If Other reason, please specify
text
Item
Please tick who took the decision
text
Who took the decision?
Code List
Please tick who took the decision
CL Item
Investigator (1)
CL Item
Subject (2)
Item Group
Laboratory tests
Date of visit
Item
Date of visit
date
Subject number
Item
Subject number
integer
Item
Has a blood sample been taken?
text
Blood sample
Code List
Has a blood sample been taken?
CL Item
Yes -> Please complete next item if different from visit date.  (1)
CL Item
No. (2)
Date blood sample was taken
Item
Date blood sample was taken
date
Item Group
Additional / Concomitant Vaccination
Item
Has any vaccine other than the study vaccine(s) been administered one starting 30 days prior to the vaccone dose and ending one month (minimum 30 days) after the vaccine dose?
text
Concomitant Vaccination
Code List
Has any vaccine other than the study vaccine(s) been administered one starting 30 days prior to the vaccone dose and ending one month (minimum 30 days) after the vaccine dose?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date (fill in items below). (2)
Item Group
Specification of concomitant Vaccination
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
Route
Item
Route
text
Administration date
Item
Administration date
date
Item Group
Additional Vaccination / Medication
Subject Number
Item
Subject Number
integer
Item
Have any medications/treatments been administered starting 30 days prior to the vaccine dose and ending one month (minimum 30 days) after the vaccine dose?
text
Medication
Code List
Have any medications/treatments been administered starting 30 days prior to the vaccine dose and ending one month (minimum 30 days) after the vaccine dose?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Item Group
Specification of additional Vaccination / Medication
Trade / Generic name
Item
Trade / Generic name
text
Medical Indication
Item
Medical Indication
text
Prophylactic
Item
Prophylactic
boolean
Total daily dose
Item
Total daily dose
float
Route
Item
Route
text
Start date
Item
Start date
date
End date
Item
End date
date
Continuing at the end of study?
Item
Continuing at the end of study?
boolean
Ritorna all'inizio della pagina 

Contatto

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

I campi contrassegnati da * sono obbligatori.

Aiuto

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