ID

23224

Description

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 2: 30 – 42 days after Visit 1

Link

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

Keywords

Versions (1)
  1. 6/29/17 6/29/17 -
Uploaded on

June 29, 2017

DOI

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License

Creative Commons BY-NC 3.0
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Non-inferiority Hib-MenAC mixed with Tritanrix-HBV Visit 2 NCT00317161

English

Visit 2 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

1 forms  
Check for Study Continuation
Description

Check for Study Continuation

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

subject return for visit 2

Data type

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.
Description

If No, please specify

Data type

integer

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

If Serious adverse event, please specify

Data type

integer

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

If Non-serious adverse event, please specify

Data type

integer

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

If Other, please specify

Data type

text

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

reason for study discontinuation

Data type

integer

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

Laboratory Tests

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

blood sample

Data type

boolean

Alias
UMLS CUI [1]
C0005834
Protocol required Concomitant Vaccination
Description

Protocol required Concomitant Vaccination

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

Have the following protocol required concomitant vaccines been administered?

Data type

boolean

Alias
UMLS CUI [1]
C0771080
Japanese encephalitis Date
Description

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

Data type

date

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

Have the following protocol required concomitant vaccines been administered?

Data type

boolean

Alias
UMLS CUI [1]
C0078048
Varicella date
Description

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

Data type

date

Alias
UMLS CUI [1,1]
C0078048
UMLS CUI [1,2]
C0011008
Large Swelling Reaction
Description

Large Swelling Reaction

Alias
UMLS CUI-1
C0038999
UMLS CUI-2
C0042196
UMLS CUI-3
C0443286
Vaccine administered for which the large swelling reaction reported:
Description

Vaccine administered

Data type

integer

Alias
UMLS CUI [1]
C0042210
Date of physical examination
Description

Date of physical examination

Data type

date

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0011008
Was the examination performed by a member of study personnel during the large swelling reaction period:
Description

performer of examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0031809
UMLS CUI [1,2]
C0025082
Date when the swelling was first considered to be a large swelling reaction:
Description

Date when the swelling was first considered to be a large swelling reaction:

Data type

date

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0011008
If occurring within 24 hours after vaccination, please specify how long after vaccination:
Description

hours after vaccination

Data type

float

Measurement units
  • hours
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0439659
UMLS CUI [2]
C0042196
hours
Measurement of the greatest diameter:
Description

Size of swelling

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0456389
mm
Type of swelling:
Description

Type of swelling

Data type

text

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0332307
Circumference of swollen limb (at the site of maximum swelling):
Description

Circumference

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0015385
UMLS CUI [1,3]
C0038999
mm
Circumference of the opposite limb (at the same level):
Description

Circumference

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0424682
UMLS CUI [1,2]
C0015385
mm
Associated signs: Temperature
Description

Please record the temperature. If temperature has been taken more than once a day please report the highest value. Please check a Yes/No box for each symptom occurring during the extensive swelling period. If other symptoms are associated with the large swelling reaction please specify under section 7.

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Temperature Route
Description

Temperature Route

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C1515974
Associated signs: Redness
Description

Redness

Data type

boolean

Alias
UMLS CUI [1]
C0332575
Redness, largest diameter
Description

Redness largest diameter

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332575
UMLS CUI [1,2]
C0456389
mm
Associated signs: Induration
Description

Induration

Data type

boolean

Alias
UMLS CUI [1]
C0332534
Induration, largest diameter
Description

Induration largest diameter

Data type

float

Measurement units
  • mm
Alias
UMLS CUI [1,1]
C0332534
UMLS CUI [1,2]
C0456389
mm
Associated signs: Pain (at administration site)
Description

Pain

Data type

boolean

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C2700396
Pain, Intensity
Description

Pain

Data type

integer

Alias
UMLS CUI [1,1]
C0030193
UMLS CUI [1,2]
C0522510
Associated signs: Functional impairment
Description

Functional impairment

Data type

boolean

Alias
UMLS CUI [1]
C4062321
Functional impairment, Intensity
Description

Functional impairment

Data type

integer

Alias
UMLS CUI [1,1]
C4062321
UMLS CUI [1,2]
C0522510
Case description
Description

Please give a clinical description of the observed large swelling reaction, including a description of the joint involved and specific associated symptoms. Please mention also eventual diagnostic(s) procedures and therapeutic interventions.

Data type

text

Alias
UMLS CUI [1,1]
C0449437
UMLS CUI [1,2]
C0678257
UMLS CUI [2]
C0038999
Last date when the swelling was still considered to be large swelling reaction:
Description

Last date of swelling

Data type

date

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0011008
If lasting for less than 24 hours, please specify duration (hours):
Description

duration swelling

Data type

float

Measurement units
  • hours
Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0449238
hours
Outcome of the large swelling reaction: swelling reaction:
Description

Outcome of the large swelling reaction:

Data type

integer

Alias
UMLS CUI [1,1]
C0085565
UMLS CUI [1,2]
C0038999
Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
Description

alternative explanation

Data type

boolean

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0681841
Alternative explanation. If Yes, please specify
Description

alternative explanation

Data type

text

Alias
UMLS CUI [1,1]
C0038999
UMLS CUI [1,2]
C0681841
Concomitant Vaccination
Description

Concomitant Vaccination

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

Subject Number

Data type

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?
Description

vaccine

Data type

integer

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

Name

Data type

text

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

Route

Data type

text

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

Administration date

Data type

date

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

Medication

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

Medication

Data type

integer

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

Medication name

Data type

text

Alias
UMLS CUI [1]
C2360065
Medical Indication
Description

Indication

Data type

text

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

Prophylactic

Data type

boolean

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

Total daily dose

Data type

text

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

Administration Route

Data type

text

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

Medication Start Date

Data type

date

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

Medication End Date

Data type

date

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

Medication Ongoing

Data type

boolean

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

Non-serious Adverse Events

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

Subject Number

Data type

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?
Description

If YES, please complete the following table.

Data type

integer

Alias
UMLS CUI [1]
C1518404
Adverse Event Number
Description

Adverse Event Number

Data type

integer

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

Description

Data type

text

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

Description

Data type

integer

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

Type of vaccine

Data type

integer

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0332307
UMLS CUI [2,1]
C1518404
UMLS CUI [2,2]
C0678257
Start Date
Description

Start Date

Data type

date

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

Start

Data type

boolean

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

End Date

Data type

date

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

Maximum Intensity

Data type

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)?
Description

Relationship to investigational product(s)

Data type

boolean

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

Outcome

Data type

text

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

Medically attended visit

Data type

boolean

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

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

Data type

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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Similar models

Visit 2 Non-inferiority Hib-MenAC mixed with Tritanrix-HBV NCT00317161

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Check for Study Continuation
C0805733 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
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 come at 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])
Item Group
Protocol required 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
Large Swelling Reaction
C0038999 (UMLS CUI-1)
C0042196 (UMLS CUI-2)
C0443286 (UMLS CUI-3)
Item
Vaccine administered for which the large swelling reaction reported:
integer
C0042210 (UMLS CUI [1])
Vaccine administered
Code List
Vaccine administered for which the large swelling reaction reported:
CL Item
DTPw-HBV/Hib-MenAC Vaccine  (1)
CL Item
DTPw-HBV/Hib Vaccine (2)
CL Item
Meningitec Vaccine (3)
Date of physical examination
Item
Date of physical examination
date
C0031809 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
performer of examination
Item
Was the examination performed by a member of study personnel during the large swelling reaction period:
boolean
C0031809 (UMLS CUI [1,1])
C0025082 (UMLS CUI [1,2])
Date when the swelling was first considered to be a large swelling reaction:
Item
Date when the swelling was first considered to be a large swelling reaction:
date
C0038999 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
hours after vaccination
Item
If occurring within 24 hours after vaccination, please specify how long after vaccination:
float
C0038999 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0042196 (UMLS CUI [2])
Size of swelling
Item
Measurement of the greatest diameter:
float
C0038999 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Item
Type of swelling:
text
C0038999 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Type of swelling
Code List
Type of swelling:
CL Item
Local swelling around injection site, not involving adjacent joint  (1)
CL Item
Diffuse swelling, not involving adjacent joint  (2)
CL Item
Swelling, involving adjacent joint (3)
Circumference
Item
Circumference of swollen limb (at the site of maximum swelling):
float
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
C0038999 (UMLS CUI [1,3])
Circumference
Item
Circumference of the opposite limb (at the same level):
float
C0424682 (UMLS CUI [1,1])
C0015385 (UMLS CUI [1,2])
Temperature
Item
Associated signs: Temperature
float
C0005903 (UMLS CUI [1])
Item
Temperature Route
text
C0005903 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
Temperature Route
Code List
Temperature Route
CL Item
Axillary (A)
CL Item
Oral (O)
CL Item
Rectal (R)
Redness
Item
Associated signs: Redness
boolean
C0332575 (UMLS CUI [1])
Redness largest diameter
Item
Redness, largest diameter
float
C0332575 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Induration
Item
Associated signs: Induration
boolean
C0332534 (UMLS CUI [1])
Induration largest diameter
Item
Induration, largest diameter
float
C0332534 (UMLS CUI [1,1])
C0456389 (UMLS CUI [1,2])
Pain
Item
Associated signs: Pain (at administration site)
boolean
C0030193 (UMLS CUI [1,1])
C2700396 (UMLS CUI [1,2])
Item
Pain, Intensity
integer
C0030193 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Pain
Code List
Pain, Intensity
CL Item
grade 1, Minor reaction to touch (1)
CL Item
grade 2, Cries / protests on touch (2)
CL Item
grade 3, Cries when limb is move (3)
Functional impairment
Item
Associated signs: Functional impairment
boolean
C4062321 (UMLS CUI [1])
Item
Functional impairment, Intensity
integer
C4062321 (UMLS CUI [1,1])
C0522510 (UMLS CUI [1,2])
Functional impairment
Code List
Functional impairment, Intensity
CL Item
Grade 1, Easily tolerated, causing minimal discomfort and not interfering with everyday activities (1)
CL Item
Grade 2, Sufficiently discomforting to interfere with normal everyday activities (2)
CL Item
Grade 3, Prevents normal everyday activities (3)
Case description
Item
Case description
text
C0449437 (UMLS CUI [1,1])
C0678257 (UMLS CUI [1,2])
C0038999 (UMLS CUI [2])
Last date of swelling
Item
Last date when the swelling was still considered to be large swelling reaction:
date
C0038999 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
duration swelling
Item
If lasting for less than 24 hours, please specify duration (hours):
float
C0038999 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Item
Outcome of the large swelling reaction: swelling reaction:
integer
C0085565 (UMLS CUI [1,1])
C0038999 (UMLS CUI [1,2])
Outcome of the large swelling reaction:
Code List
Outcome of the large swelling reaction: swelling reaction:
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)
alternative explanation
Item
Is there an alternative explanation for the swelling? (e.g.: allergy, infection, trauma, underlying conditions)
boolean
C0038999 (UMLS CUI [1,1])
C0681841 (UMLS CUI [1,2])
alternative explanation
Item
Alternative explanation. If Yes, please specify
text
C0038999 (UMLS CUI [1,1])
C0681841 (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)
Item
Non-serious adverse events: Description, Type of vaccine
integer
C0042210 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
C1518404 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
Type of vaccine
Code List
Non-serious adverse events: Description, Type of vaccine
CL Item
DTPw-HBV/Hib-MenAC vaccine  (1)
CL Item
DTPw-HBV/Hib vaccine  (2)
CL Item
Meningitec vaccine (3)
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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