ID

32066

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 documentation of study continuation and reasons for non continuation. To be checked at each visit from visit 2 onward. Visit 2 -> Timing: Day 30, Age: 10 weeks +/- 1 week (one item less) Visit 3 -> Timing: Day 45, Age: 12 weeks +/- 1 week Visit 4 -> Timing: Day 60, Age: 14 weeks +/- 1 week Visit 5 -> Timing: Day 75, Age: 16 weeks +/- 1 week Visit 6 -> Timing: Day 105, Age: 20 weeks +/- 1 week

Link

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

Keywords

Versions (1)
  1. 10/16/18 10/16/18 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

October 16, 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 Continuation

1 forms  
  1. StudyEvent: ODM
    1. Study Continuation
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
UMLS CUI [1]
C1549755
Check for study continuation
Description

Check for study continuation

Alias
UMLS CUI-1
C0805733
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did the subject return for this visit?
Description

if yes: please complete all necessary forms for this visit. if no: please complete the rest of the items of this form.

Data type

boolean

Alias
UMLS CUI [1]
C0805733
If no: Same reason and decision as previous event?
Description

if yes, you can skip the following item. This is only applicable from Visit 3 onward (not applicable for visit 2).

Data type

boolean

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0566251
Please tick the ONE most appropriate reason and skip the other forms of this visit.
Description

Reason for discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0457454
UMLS CUI [1,2]
C0566251
If SAE, please specify SAE N°
Description

If the most appropriate reason for discontinuation is a serious adverse event, please specify SAE No. and complete SAE form.

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
If (unsolicited) non-serious adverse event, please specify unsolicited AE N°
Description

If the most appropriate reason for discontinuation is a non-serious adverse event (unsolicited), please specify unsolicited AE No. and complete Non-serious Adverse Event form. If solicited AE, please complete the solicited adverse event code item instead.

Data type

integer

Alias
UMLS CUI [1,1]
C4055646
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0237753
If (solicited) non-serious adverse event, please specify solicited AE code.
Description

If the most appropriate reason for discontinuation is a non-serious adverse event (solicited), please specify solicited AE code and complete solicited Non-serious Adverse Event form. If unsolicited non-serious adverse event, please complete the Unsoliceted AE number item.

Data type

integer

Alias
UMLS CUI [1,1]
C1517001
UMLS CUI [1,2]
C1518404
UMLS CUI [1,3]
C0237753
Other reason for discontinuation, please specify.
Description

If the reason is not an adverse event, please specify, e.g. consent withdrawal protocol violation, ...

Data type

text

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

Person deciding about discontinuation

Data type

text

Alias
UMLS CUI [1,1]
C0679006
UMLS CUI [1,2]
C0457454
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Similar models

Study Continuation

1 forms
  1. StudyEvent: ODM
    1. Study Continuation
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
C1549755 (UMLS CUI [1])
Visit Number
Code List
Visit Number
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
Item Group
Check for study continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Continuation status
Item
Did the subject return for this visit?
boolean
C0805733 (UMLS CUI [1])
Discontinuation: same reason
Item
If no: Same reason and decision as previous event?
boolean
C0457454 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Item
Please tick the ONE most appropriate reason and skip the other forms of this visit.
text
C0457454 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
Reason for discontinuation
Code List
Please tick the ONE most appropriate reason and skip the other forms of this visit.
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 SAE, please specify SAE N°
text
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
unsolicited AE number
Item
If (unsolicited) non-serious adverse event, please specify unsolicited AE N°
integer
C4055646 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Solicited AE code
Item
If (solicited) non-serious adverse event, please specify solicited AE code.
integer
C1517001 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
Other reason
Item
Other reason for discontinuation, 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])
Trial subject ID Participating Group
Code List
Please tick who took the decision.
CL Item
Investigator (I)
CL Item
Parents/Guardians (P)
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