ID

32060

Beskrivning

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 details Elimination Criteria. They need to be checked at each visit prior to any other procedure, starting form Visit 2. Visit 2 -> Timing: Day 30, Age: 10 weeks +/- 1 week 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

Länk

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

Nyckelord

  1. 2018-10-16 2018-10-16 - Sarah Riepenhausen
Rättsinnehavare

GlaxoSmithKline

Uppladdad den

16 oktober 2018

DOI

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Licens

Creative Commons BY-NC 3.0

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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334

Elimination Criteria during the Study

Administrative Data
Beskrivning

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Beskrivning

Date of visit

Datatyp

date

Alias
UMLS CUI [1]
C1320303
Visit number
Beskrivning

Visit number

Datatyp

integer

Alias
UMLS CUI [1]
C1549755
Elimination Criteria during the Study
Beskrivning

Elimination Criteria during the Study

Alias
UMLS CUI-1
C0680251
(A) up to visit 3, previous confirmed occurence of RV GE.
Beskrivning

previous RV GE

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035870
UMLS CUI [1,2]
C0017160
(B) Gastroenteritis (diarrhea) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
Beskrivning

Diarrhea

Datatyp

boolean

Alias
UMLS CUI [1]
C0011991
(C) Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
Beskrivning

investigational or non-registered product (drug or vaccine)

Datatyp

boolean

Alias
UMLS CUI [1]
C0304229
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C1517586
(D) Chronic administration (defined as more than 14 days) of immunosuppressants during the study period. (Topical steroids are allowed.)
Beskrivning

undefined item

Datatyp

boolean

Alias
UMLS CUI [1]
C0021081
(E) Administration of a vaccine not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
Beskrivning

Vaccine administration within 14 days before/after study vaccination nor forseen in study protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2368628
UMLS CUI [1,2]
C2348563
(F) Administration of immunoglobulins and/or any blood products during the study period.
Beskrivning

Immunoglobulins or blood products during study

Datatyp

boolean

Alias
UMLS CUI [1]
C0021027
UMLS CUI [2]
C0371802
(G) Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
Beskrivning

immunosuppressive or immunodeficient condition, including HIV infection

Datatyp

boolean

Alias
UMLS CUI [1]
C4048329
UMLS CUI [2]
C0021051
UMLS CUI [3]
C0019693

Similar models

Elimination Criteria during the Study

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
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
Elimination Criteria during the Study
C0680251 (UMLS CUI-1)
previous RV GE
Item
(A) up to visit 3, previous confirmed occurence of RV GE.
boolean
C0035870 (UMLS CUI [1,1])
C0017160 (UMLS CUI [1,2])
Diarrhea
Item
(B) Gastroenteritis (diarrhea) within 7 days preceding the study vaccine administration (warrants deferral of the vaccination).
boolean
C0011991 (UMLS CUI [1])
investigational or non-registered product (drug or vaccine)
Item
(C) Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the study period
boolean
C0304229 (UMLS CUI [1])
C0042210 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
undefined item
Item
(D) Chronic administration (defined as more than 14 days) of immunosuppressants during the study period. (Topical steroids are allowed.)
boolean
C0021081 (UMLS CUI [1])
Vaccine administration within 14 days before/after study vaccination nor forseen in study protocol
Item
(E) Administration of a vaccine not foreseen by the study protocol during the period starting from 14 days before each dose of study vaccine(s) and ending 14 days after.
boolean
C2368628 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Immunoglobulins or blood products during study
Item
(F) Administration of immunoglobulins and/or any blood products during the study period.
boolean
C0021027 (UMLS CUI [1])
C0371802 (UMLS CUI [2])
immunosuppressive or immunodeficient condition, including HIV infection
Item
(G) Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
boolean
C4048329 (UMLS CUI [1])
C0021051 (UMLS CUI [2])
C0019693 (UMLS CUI [3])

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