ID

23093

Description

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

Versions (3)
  1. 6/23/17 6/23/17 -
  2. 6/23/17 6/23/17 -
  3. 9/25/17 9/25/17 -
Uploaded on

June 23, 2017

DOI

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License

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)

English

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

1 forms  
General Information
Description

General Information

Subject number
Description

Subject number

Data type

integer

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

Check for study continuation

Data type

text

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

To be completet only for subject receiving additional vaccination

Data type

text

If Other reason, please specify
Description

Specification of other reason

Data type

text

Please tick who took the decision
Description

Who took the decision?

Data type

text

Laboratory tests
Description

Laboratory tests

Date of visit
Description

Date of visit

Data type

date

Subject number
Description

Subject number

Data type

integer

Has a blood sample been taken?
Description

Blood sample

Data type

text

Date blood sample was taken
Description

Date blood sample was taken

Data type

date

Additional / Concomitant Vaccination
Description

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?
Description

To be completed only for subject receiving additional vaccination.

Data type

text

Specification of concomitant Vaccination
Description

Specification of concomitant Vaccination

Trade / (Generic) Name
Description

Trade / (Generic) Name

Data type

text

Route
Description

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

Data type

text

Administration date
Description

Administration date

Data type

date

Additional Vaccination / Medication
Description

Additional Vaccination / Medication

Subject Number
Description

Subject Number

Data type

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?
Description

Medication

Data type

text

Specification of additional Vaccination / Medication
Description

Specification of additional Vaccination / Medication

Trade / Generic name
Description

Trade / Generic name

Data type

text

Medical Indication
Description

Medical Indication

Data type

text

Prophylactic
Description

Prophylactic

Data type

boolean

Total daily dose
Description

Total daily dose

Data type

float

Route
Description

Route

Data type

text

Start date
Description

Start date

Data type

date

End date
Description

End date

Data type

date

Continuing at the end of study?
Description

Continuing at the end of study?

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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