ID

23228

Beschreibung

Study ID: 100480 Clinical Study ID: 100480 Study Title: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00317161 https://clinicaltrials.gov/ct2/show/NCT00317161 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine Trade Name: Tritanrix HepB/Hiberix Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis Visit 4: 30 – 42 days after visit 3

Link

https://clinicaltrials.gov/ct2/show/NCT00317161

Stichworte

Versionen (1)
  1. 29.06.17 29.06.17 -
Hochgeladen am

29. Juni 2017

DOI

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Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Visit 4 NCT00317161

Englisch

Visit 4 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

1 Formulare  
Check for Study Continuation
Beschreibung

Check for Study Continuation

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

subject return for visit 2

Datentyp

integer

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0805733
UMLS CUI [1,3]
C0008976
Please tick the ONE most appropriate reason and skip the following pages of this visit.
Beschreibung

If No, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
SAE Number
Beschreibung

If Serious adverse event, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0237753
AE Number or Code
Beschreibung

If Non-serious adverse event, please specify

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Other reason for Study Discontinuation
Beschreibung

If Other, please specify

Datentyp

text

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
reason for study discontinuation
Beschreibung

reason for study discontinuation

Datentyp

integer

Alias
UMLS CUI [1,1]
C0392360
UMLS CUI [1,2]
C0457454
UMLS CUI [1,3]
C0008976
Laboratory Tests
Beschreibung

Laboratory Tests

Alias
UMLS CUI-1
C0022885
UMLS CUI-2
C0005834
Has a blood sample been taken?
Beschreibung

blood sample

Datentyp

boolean

Alias
UMLS CUI [1]
C0005834
Date sample taken
Beschreibung

Please complete only if different from visit date

Datentyp

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
Protocol incentives Concomitant Vaccination
Beschreibung

Protocol incentives Concomitant Vaccination

Alias
UMLS CUI-1
C2347852
UMLS CUI-2
C0771080
UMLS CUI-3
C0078048
Japanese encephalitis
Beschreibung

Have the following protocol required concomitant vaccines been administered?

Datentyp

boolean

Alias
UMLS CUI [1]
C0771080
Japanese encephalitis Date
Beschreibung

If Yes, please complete only if different from visit date.

Datentyp

date

Alias
UMLS CUI [1,1]
C0771080
UMLS CUI [1,2]
C0011008
Varicella
Beschreibung

Have the following protocol required concomitant vaccines been administered?

Datentyp

boolean

Alias
UMLS CUI [1]
C0078048
Varicella date
Beschreibung

If Yes, please complete only if different from visit date.

Datentyp

date

Alias
UMLS CUI [1,1]
C0078048
UMLS CUI [1,2]
C0011008
Concomitant Vaccination
Beschreibung

Concomitant Vaccination

Alias
UMLS CUI-1
C0042196
UMLS CUI-2
C2347852
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
Beschreibung

vaccine

Datentyp

integer

Alias
UMLS CUI [1]
C0042210
Trade/Generic Name
Beschreibung

Name

Datentyp

text

Alias
UMLS CUI [1,1]
C0027365
UMLS CUI [1,2]
C0042210
Route
Beschreibung

Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0042210
Administration date
Beschreibung

Administration date

Datentyp

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
UMLS CUI [1,3]
C0042210
Medication
Beschreibung

Medication

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
C0087111
Have any medications/treatments been administered during study period?
Beschreibung

Medication

Datentyp

integer

Alias
UMLS CUI [1]
C0013227
UMLS CUI [2]
C0087111
Trade or generic name
Beschreibung

Medication name

Datentyp

text

Alias
UMLS CUI [1]
C2360065
Medical Indication
Beschreibung

Indication

Datentyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Medical Indication: Prophylactic?
Beschreibung

Prophylactic

Datentyp

boolean

Alias
UMLS CUI [1]
C0199176
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0013227
Total daily dose
Beschreibung

Total daily dose

Datentyp

text

Alias
UMLS CUI [1,1]
C2348070
UMLS CUI [1,2]
C0013227
Route
Beschreibung

Administration Route

Datentyp

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Start Date
Beschreibung

Medication Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0013227
End Date
Beschreibung

Medication End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0013227
Medication Ongoing: tick box if continuing at end of study
Beschreibung

Medication Ongoing

Datentyp

boolean

Alias
UMLS CUI [1]
C2826666
Non-serious Adverse Events
Beschreibung

Non-serious Adverse Events

Alias
UMLS CUI-1
C1518404
UMLS CUI-2
C0042210
Subject Number
Beschreibung

Subject Number

Datentyp

text

Alias
UMLS CUI [1]
C2348585
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
Beschreibung

If YES, please complete the following table.

Datentyp

integer

Alias
UMLS CUI [1]
C1518404
Adverse Event Number
Beschreibung

Adverse Event Number

Datentyp

integer

Alias
UMLS CUI [1,1]
C1518404
UMLS CUI [1,2]
C0237753
Non-serious adverse events: Description
Beschreibung

Description

Datentyp

text

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Non-serious adverse events: Description
Beschreibung

Description

Datentyp

integer

Alias
UMLS CUI [1,1]
C0678257
UMLS CUI [1,2]
C1518404
Start Date
Beschreibung

Start Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C1518404
Start: during immediate post-vaccination period (protocol specific: 0 – 30 minutes)
Beschreibung

Start

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0439659
UMLS CUI [1,2]
C1518404
End Date
Beschreibung

End Date

Datentyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C1518404
Maximum Intensity
Beschreibung

Maximum Intensity

Datentyp

integer

Alias
UMLS CUI [1,1]
C1710056
UMLS CUI [1,2]
C1518404
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
Beschreibung

Relationship to investigational product(s)

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Outcome
Beschreibung

Outcome

Datentyp

text

Alias
UMLS CUI [1,1]
C1705586
UMLS CUI [1,2]
C1518404
Medically attended visit?
Beschreibung

Medically attended visit

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [2]
C1518404
Medically attended visit type
Beschreibung

Did the subject seek medical advice? If yes, please specify type

Datentyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
UMLS CUI [1,3]
C1386497
UMLS CUI [2]
C1518404
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Ähnliche Modelle

Visit 4 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Item
Did the subject return for visit 2 ?
integer
C0545082 (UMLS CUI [1,1])
C0805733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
subject return for visit 2
Code List
Did the subject return for visit 2 ?
CL Item
Yes, please complete the next pages. (1)
CL Item
No, please specify (2)
Item
Please tick the ONE most appropriate reason and skip the following pages of this visit.
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for study discontinuation
Code List
Please tick the ONE most appropriate reason and skip the following pages of this visit.
CL Item
Serious adverse Event (1)
CL Item
Non-Serious adverse Event (2)
CL Item
Other (3)
SAE Number
Item
SAE Number
integer
C1519255 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
AE Number
Item
AE Number or Code
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Other reason for Study Discontinuation
Item
Other reason for Study Discontinuation
text
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
Item
reason for study discontinuation
integer
C0392360 (UMLS CUI [1,1])
C0457454 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
reason for study discontinuation
Code List
reason for study discontinuation
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Item Group
Laboratory Tests
C0022885 (UMLS CUI-1)
C0005834 (UMLS CUI-2)
blood sample
Item
Has a blood sample been taken?
boolean
C0005834 (UMLS CUI [1])
Date sample taken
Item
Date sample taken
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Protocol incentives Concomitant Vaccination
C2347852 (UMLS CUI-1)
C0771080 (UMLS CUI-2)
C0078048 (UMLS CUI-3)
Japanese encephalitis
Item
Japanese encephalitis
boolean
C0771080 (UMLS CUI [1])
Japanese encephalitis Date
Item
Japanese encephalitis Date
date
C0771080 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Varicella
Item
Varicella
boolean
C0078048 (UMLS CUI [1])
Varicella date
Item
Varicella date
date
C0078048 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Concomitant Vaccination
C0042196 (UMLS CUI-1)
C2347852 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
integer
C0042210 (UMLS CUI [1])
vaccine
Code List
Has any vaccine other than the study vaccine(s) been administered during the timeframe as specified in the Protocol?
CL Item
No (1)
CL Item
Yes, please record concomitant vaccination with trade name and / or generic name, and vaccine administration date. (2)
Name
Item
Trade/Generic Name
text
C0027365 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
Route
Code List
Route
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
Administration date
Item
Administration date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Item Group
Medication
C0013227 (UMLS CUI-1)
C0087111 (UMLS CUI-2)
Item
Have any medications/treatments been administered during study period?
integer
C0013227 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
Medication
Code List
Have any medications/treatments been administered during study period?
CL Item
No (1)
CL Item
Yes, please complete the following table. (2)
Medication name
Item
Trade or generic name
text
C2360065 (UMLS CUI [1])
Indication
Item
Medical Indication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Prophylactic
Item
Medical Indication: Prophylactic?
boolean
C0199176 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Total daily dose
Item
Total daily dose
text
C2348070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Item
Route
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Administration Route
Code List
Route
CL Item
External (EXT)
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Rectal (PR)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Topical (TO)
CL Item
Unknown (UNK)
CL Item
Vaginal (VA)
Medication Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Medication Ongoing
Item
Medication Ongoing: tick box if continuing at end of study
boolean
C2826666 (UMLS CUI [1])
Item Group
Non-serious Adverse Events
C1518404 (UMLS CUI-1)
C0042210 (UMLS CUI-2)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
integer
C1518404 (UMLS CUI [1])
Withdrawal
Code List
Has any non-serious adverse events occurred within one month (minimum 30 days) post-vaccination, excluding those recorded on the Solicited Adverse Events pages?
CL Item
No (1)
CL Item
Yes, please complete the following table (2)
Adverse Event Number
Item
Adverse Event Number
integer
C1518404 (UMLS CUI [1,1])
C0237753 (UMLS CUI [1,2])
Description
Item
Non-serious adverse events: Description
text
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Non-serious adverse events: Description
integer
C0678257 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Description
Code List
Non-serious adverse events: Description
CL Item
Administration sites (1)
CL Item
Non-administration site (2)
Start Date
Item
Start Date
date
C0808070 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Start
Item
Start: during immediate post-vaccination period (protocol specific: 0 – 30 minutes)
boolean
C0439659 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
End Date
Item
End Date
date
C0806020 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Item
Maximum Intensity
integer
C1710056 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Withdrawal
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Modearte (2)
CL Item
Severe (3)
Relationship to investigational product(s)
Item
Is there a reasonable possibility that the non-serious AE may have been caused by the investigational product(s)?
boolean
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Item
Outcome
text
C1705586 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Outcome
Code List
Outcome
CL Item
Recovered / Resolved (1)
CL Item
Recovering / resolving (2)
CL Item
Not recovered / not resolved (3)
CL Item
Recovered with sequelae / Resolved with sequelae (4)
Medically attended visit
Item
Medically attended visit?
boolean
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2])
Item
Medically attended visit type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
C1518404 (UMLS CUI [2])
Medical advice type
Code List
Medically attended visit type
CL Item
Hospitalisation (HO)
CL Item
Emergency room (ER)
CL Item
Medical doctor (MD)
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