ID

32085

Beschrijving

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 concomitant vaccinations (e.g., BCG) excluding protocol-planned vaccinations (HRV vaccine, OPV, DTPw-HB in Visits 1-5), as well as contraindicated (immune globulins) and other medication having been administered.

Link

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

Trefwoorden

Versies (1)
  1. 17-10-18 17-10-18 - Sarah Riepenhausen
Houder van rechten

GlaxoSmithKline

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17 oktober 2018

DOI

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Licentie

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

Engels

Concomitant Vaccination and (contraindicated) Medication

1 Formulieren  
Administrative Data
Beschrijving

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschrijving

subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Concomitant Vaccination
Beschrijving

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Has any vaccine other than the study vaccine(s) except OPV and DTPw-HB already recorded in the CRF sections at visits 1, 2, 3, 4 and 5 been administered since birth until visit 6 ?
Beschrijving

If yes, please record concomitant vaccination with trade name and/or generic name, route and vaccine administration date in the following itemgroup.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0042196
UMLS CUI [1,2]
C2347852
Concomitant Vaccination Characteristics
Beschrijving

Concomitant Vaccination Characteristics

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
UMLS CUI-3
C2348235
Trade / (Generic) Name
Beschrijving

Trade / (Generic) Name

Datatype

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0042210
Route of Administration
Beschrijving

Route of Administration

Datatype

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration Date
Beschrijving

Administration Date

Datatype

date

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C1533734
UMLS CUI [1,3]
C0011008
Commentary field for GSK
Beschrijving

Commentary field for GSK

Datatype

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0947611
Contraindicated Medication / Medication
Beschrijving

Contraindicated Medication / Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0522473
UMLS CUI-3
C0525058
Have any medications specifically contraindicated and resulting in an elimination criteria (any immunoglobulins) been administered since visit 1 until visit 3 or have any medications/treatments been administered since visit 3 until visit 6 ?
Beschrijving

All concomitant medication, with the exception of vitamins and/or dietary supplements, administered at ANY time during the period starting with administration of each dose of study vaccine (Visit 3) and ending at Visit 6 are to be recorded with generic name of the medication (trade names are allowed for combination drugs, i.e. multi-component drugs), medical indication, total daily dose, route of administration, start and end dates of treatment. Any treatments and/or medications specifically contraindicated, e.g., any immunoglobulins, other blood products and any immune modifying drugs administered since birth or at any time during the study period are to be recorded with generic name of the medication (trade names are allowed for combination drugs only), medical indication, total daily dose, route of administration, start and end dates of treatment. Concomitant medication administered for the treatment of an AE or SAE within the follow-up period for adverse events must be recorded in the CRF with generic name of the medication (trade names are allowed for combination drugs only), medical indication (including which AE/SAE), total daily dose, route of administration, start and end dates of treatment. If yes, please complete the following item group.

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
Medication Characteristics
Beschrijving

Medication Characteristics

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C2348235
Trade / (Generic) Name
Beschrijving

Trade / (Generic) Name

Datatype

text

Alias
UMLS CUI [1]
C2360065
Medical indication
Beschrijving

Medical indication

Datatype

text

Alias
UMLS CUI [1]
C3146298
Medical indication: prophylactic?
Beschrijving

A prophylactic medication is a medication administered in the absence of ANY symptom and in anticipation of a reaction to the vaccination (e.g. an anti-pyretic is considered to be prophylactic when it is given in the absence of fever [rectal temperature < 38°C] and any other symptom, to prevent fever from occurring). Any concomitant medication administered prophylactically in anticipation of reaction to the vaccination must be recorded in the CRF with generic name of the medication (trade names are allowed for combination drugs only), total daily dose, route of administration, start and end dates of treatment and coded as ‘Prophylactic’.

Datatype

boolean

Alias
UMLS CUI [1,1]
C0199176
UMLS CUI [1,2]
C3146298
Total daily dose
Beschrijving

Total daily dose

Datatype

text

Alias
UMLS CUI [1]
C2348070
Route of Administration
Beschrijving

Route of Administration

Datatype

text

Alias
UMLS CUI [1]
C0013153
Administration Date
Beschrijving

Administration Date

Datatype

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
Start date of Administration
Beschrijving

Start date of Administration

Datatype

date

Alias
UMLS CUI [1]
C0808070
End date of Administration
Beschrijving

If the administration ended during the time of the study.

Datatype

date

Alias
UMLS CUI [1]
C0806020
Ongoing Administration
Beschrijving

Ongoing Administration

Datatype

boolean

Alias
UMLS CUI [1]
C2826666
Commentary field for GSK
Beschrijving

Commentary field for GSK

Datatype

text

Alias
UMLS CUI [1,1]
C0008961
UMLS CUI [1,2]
C0947611
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Similar models

Concomitant Vaccination and (contraindicated) Medication

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
subject number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Concomitant Vaccination
Item
Has any vaccine other than the study vaccine(s) except OPV and DTPw-HB already recorded in the CRF sections at visits 1, 2, 3, 4 and 5 been administered since birth until visit 6 ?
boolean
C0042196 (UMLS CUI [1,1])
C2347852 (UMLS CUI [1,2])
Item Group
Concomitant Vaccination Characteristics
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
C2348235 (UMLS CUI-3)
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
C2360065 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route of Administration
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route of Administration
Code List
Route of Administration
CL Item
intradermal (ID)
CL Item
Parenteral (PE)
CL Item
Inhalation (IH)
CL Item
oral (PO)
CL Item
Intramuscular (IM)
CL Item
subcutaneous (SC)
CL Item
intravenous (IV)
CL Item
sublingual (SL)
CL Item
intranasal (NA)
CL Item
Transdermal (TD)
CL Item
other (OTH)
CL Item
unknown (UNK)
Administration Date
Item
Administration Date
date
C0042210 (UMLS CUI [1,1])
C1533734 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Commentary field for GSK
Item
Commentary field for GSK
text
C0008961 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
Item Group
Contraindicated Medication / Medication
C0013227 (UMLS CUI-1)
C0522473 (UMLS CUI-2)
C0525058 (UMLS CUI-3)
Contraindicated Medication / Medication
Item
Have any medications specifically contraindicated and resulting in an elimination criteria (any immunoglobulins) been administered since visit 1 until visit 3 or have any medications/treatments been administered since visit 3 until visit 6 ?
boolean
C2347852 (UMLS CUI [1])
Item Group
Medication Characteristics
C2347852 (UMLS CUI-1)
C2348235 (UMLS CUI-2)
Trade / (Generic) Name
Item
Trade / (Generic) Name
text
C2360065 (UMLS CUI [1])
Item
Medical indication
text
C3146298 (UMLS CUI [1])
Route of Administration
Code List
Medical indication
Medical indication prophylactic
Item
Medical indication: prophylactic?
boolean
C0199176 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1])
Item
Route of Administration
text
C0013153 (UMLS CUI [1])
Route of Administration
Code List
Route of Administration
CL Item
intradermal (ID)
CL Item
parenteral (PE)
CL Item
inhalation (IH)
CL Item
oral (PO)
CL Item
intramuscular (IM)
CL Item
subcutaneous (SC)
CL Item
intravenous (IV)
CL Item
sublingual (SL)
CL Item
intranasal (NA)
CL Item
transdermal (TD)
CL Item
other (OTH)
CL Item
unknown (UNK)
CL Item
external (EXT)
CL Item
intraarticular (IR)
CL Item
intrathecal (IT)
CL Item
rectal (PR)
CL Item
topical (TO)
CL Item
vaginal (VA)
Administration Date
Item
Administration Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Start date of Administration
Item
Start date of Administration
date
C0808070 (UMLS CUI [1])
End date of Administration
Item
End date of Administration
date
C0806020 (UMLS CUI [1])
Ongoing Administration
Item
Ongoing Administration
boolean
C2826666 (UMLS CUI [1])
Commentary field for GSK
Item
Commentary field for GSK
text
C0008961 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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