ID

32081

Description

Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form is for the documentation of the administration of the study vaccination on Visit 3 (Dose 1) and Visit 5 (Dose 2). Visit 3 -> Timing: Day 45, Age: 12 weeks +/- 1 week Visit 5 -> Timing: Day 75, Age: 16 weeks +/- 1 week

Link

https://clinicaltrials.gov/ct2/show/NCT00139334

Keywords

Versions (1)
  1. 10/17/18 10/17/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 17, 2018

DOI

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License

Creative Commons BY-NC 3.0
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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334

English

Study Vaccine Administration

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Data type

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

Date of visit

Data type

date

Alias
UMLS CUI [1]
C1320303
Visit number
Description

Visit number

Data type

integer

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16696
NCI Thesaurus Property
C25385
UMLS CUI [1]
C1549755
Vaccine Administration
Description

Vaccine Administration

Alias
UMLS CUI-1
C2368628
Date of vaccination
Description

fill in only if different from visit date

Data type

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0042196
Pre-Vaccination temperature
Description

Pre-Vaccination temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
°C
Route of taking pre-vaccination temperature
Description

Route of taking pre-vaccination temperature

Data type

text

Alias
UMLS CUI [1,1]
C0489453
UMLS CUI [1,2]
C0042196
UMLS CUI [1,3]
C0332152
Vaccine Administration
Description

Side/Site Route always oral Only one box must be ticked by vaccine

Data type

text

Alias
UMLS CUI [1]
C2368628
If replacement vial, please give vial number.
Description

Replacement vial number

Data type

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0600091
Comment, if replacement vial
Description

Replacement vial Comments

Data type

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0559956
UMLS CUI [1,3]
C0947611
If wrong vial number, please give new number.
Description

Wrong vial number, new number

Data type

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C3827420
UMLS CUI [1,3]
C0600091
Comment, if Wrong vial number
Description

Wrong vial number, comments.

Data type

text

Alias
UMLS CUI [1,1]
C0184301
UMLS CUI [1,2]
C0600091
UMLS CUI [1,3]
C3827420
UMLS CUI [1,4]
C0947611
If not administered, why not administered? Please tick the ONE most appropriate category for non-administration.
Description

Reason for not administering vaccination

Data type

text

Alias
UMLS CUI [1,1]
C0566251
UMLS CUI [1,2]
C2368628
UMLS CUI [1,3]
C1272696
If the reason for non-administration is serious adverse event, please specify SAE No. and complete the serious adverse event form.
Description

SAE number

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If the reason for non-administration is a non-serious adverse event (unsolicited), please specify unsolicited AE No and complete the Non-serious adverse event form.
Description

If solicited, please complete the following item for solicited AE code.

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C4055646
If the reason for non-administration is a non-serious adverse event (solicited), please specify solicited AE Code and complete the Non-serious adverse event form.
Description

If unsolicited, please complete the previous item for unsolicited AE number.

Data type

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
UMLS CUI [1,3]
C1517001
If other reason for non-administration, please specify
Description

e.g. consent withdrawal, protocol violation, ...

Data type

text

Alias
UMLS CUI [1]
C3840932
Please tick who took the decision
Description

person to decide about not-administration

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0457454
Regurgitation within 30 minutes after HRV vaccine or placebo?
Description

Should the subject regurgitate or vomit after vaccination, no additional HRV vaccine/placebo should be administered at this visit.

Data type

text

Alias
UMLS CUI [1,1]
C0232605
UMLS CUI [1,2]
C2368628
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Similar models

Study Vaccine Administration

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit number
integer
C25337 (NCI Thesaurus ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 3 (3)
CL Item
Visit 5 (5)
Item Group
Vaccine Administration
C2368628 (UMLS CUI-1)
Date of vaccination
Item
Date of vaccination
date
C0011008 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
Pre-Vaccination temperature
Item
Pre-Vaccination temperature
float
C0005903 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Item
Route of taking pre-vaccination temperature
text
C0489453 (UMLS CUI [1,1])
C0042196 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
Route of taking pre-vaccination temperature
Code List
Route of taking pre-vaccination temperature
CL Item
Axillary (A)
CL Item
Rectal (R)
Item
Vaccine Administration
text
C2368628 (UMLS CUI [1])
Vaccine Administration
Code List
Vaccine Administration
CL Item
HRV Vaccine or its placebo (S)
CL Item
Replacement vial (R)
CL Item
Wrong vial number (W)
CL Item
Not administered (N)
Replacement vial number
Item
If replacement vial, please give vial number.
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Replacement vial Comments
Item
Comment, if replacement vial
text
C0184301 (UMLS CUI [1,1])
C0559956 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Wrong vial number, new number
Item
If wrong vial number, please give new number.
text
C0184301 (UMLS CUI [1,1])
C3827420 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Wrong vial number, comments.
Item
Comment, if Wrong vial number
text
C0184301 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
C3827420 (UMLS CUI [1,3])
C0947611 (UMLS CUI [1,4])
Item
If not administered, why not administered? Please tick the ONE most appropriate category for non-administration.
text
C0566251 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,3])
Reason for discontinuation
Code List
If not administered, why not administered? Please tick the ONE most appropriate category for non-administration.
CL Item
Serious adverse event (complete the Serious Adverse Event form) ((SAE))
CL Item
Non-Serious adverse event (complete the Non-serious Adverse Event form) ((AEX))
CL Item
Other ((OTH))
SAE number
Item
If the reason for non-administration is serious adverse event, please specify SAE No. and complete the serious adverse event form.
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Unsolicited AE number
Item
If the reason for non-administration is a non-serious adverse event (unsolicited), please specify unsolicited AE No and complete the Non-serious adverse event form.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
Solicited AE code
Item
If the reason for non-administration is a non-serious adverse event (solicited), please specify solicited AE Code and complete the Non-serious adverse event form.
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
Other reason for non-administration
Item
If other reason for non-administration, please specify
text
C3840932 (UMLS CUI [1])
Item
Please tick who took the decision
text
C0679006 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
person to decide not-administration
Code List
Please tick who took the decision
CL Item
investigator (I)
CL Item
Parents/Guardians (P)
Item
Regurgitation within 30 minutes after HRV vaccine or placebo?
text
C0232605 (UMLS CUI [1,1])
C2368628 (UMLS CUI [1,2])
Regurgitation <= 30 minutes after administration of vaccine or placebo
Code List
Regurgitation within 30 minutes after HRV vaccine or placebo?
CL Item
yes (yes)
CL Item
no (no)
CL Item
NA (for "not administered" only) (NA)
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