ID

23093

Beskrivning

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

Nyckelord

Versioner (3)
  1. 2017-06-23 2017-06-23 -
  2. 2017-06-23 2017-06-23 -
  3. 2017-09-25 2017-09-25 -
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23 juni 2017

DOI

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Creative Commons BY-NC 3.0
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Comparative study of the immunogenicity and reactogenicity of three different lots of GlaxoSmithKline Biologicals’ combined hepatitis A - hepatitis B (Visit 23 Year 15)

Engelsk

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

1 Formulär  
General Information
Beskrivning

General Information

Subject number
Beskrivning

Subject number

Datatyp

integer

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

Check for study continuation

Datatyp

text

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

To be completet only for subject receiving additional vaccination

Datatyp

text

If Other reason, please specify
Beskrivning

Specification of other reason

Datatyp

text

Please tick who took the decision
Beskrivning

Who took the decision?

Datatyp

text

Laboratory tests
Beskrivning

Laboratory tests

Date of visit
Beskrivning

Date of visit

Datatyp

date

Subject number
Beskrivning

Subject number

Datatyp

integer

Has a blood sample been taken?
Beskrivning

Blood sample

Datatyp

text

Date blood sample was taken
Beskrivning

Date blood sample was taken

Datatyp

date

Additional / Concomitant Vaccination
Beskrivning

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?
Beskrivning

To be completed only for subject receiving additional vaccination.

Datatyp

text

Specification of concomitant Vaccination
Beskrivning

Specification of concomitant Vaccination

Trade / (Generic) Name
Beskrivning

Trade / (Generic) Name

Datatyp

text

Route
Beskrivning

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

Datatyp

text

Administration date
Beskrivning

Administration date

Datatyp

date

Additional Vaccination / Medication
Beskrivning

Additional Vaccination / Medication

Subject Number
Beskrivning

Subject Number

Datatyp

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?
Beskrivning

Medication

Datatyp

text

Specification of additional Vaccination / Medication
Beskrivning

Specification of additional Vaccination / Medication

Trade / Generic name
Beskrivning

Trade / Generic name

Datatyp

text

Medical Indication
Beskrivning

Medical Indication

Datatyp

text

Prophylactic
Beskrivning

Prophylactic

Datatyp

boolean

Total daily dose
Beskrivning

Total daily dose

Datatyp

float

Route
Beskrivning

Route

Datatyp

text

Start date
Beskrivning

Start date

Datatyp

date

End date
Beskrivning

End date

Datatyp

date

Continuing at the end of study?
Beskrivning

Continuing at the end of study?

Datatyp

boolean

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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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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
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