ID

35812

Description

Study ID: 102370 (primary study) Clinical Study ID: 102370 Study Title: A multicentre when given according to the 2-4-6 month schedule to healthy infants with booster dose at 12 to 15 months Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00134719 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Haemophilus influenzae Type b, Meningococcal C and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: BIO HIB-MENCY-TT; MenHibrix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis

Keywords

Versions (1)
  1. 3/25/19 3/25/19 -
Copyright Holder

GlaxoSmithKline

Uploaded on

March 25, 2019

DOI

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License

Creative Commons BY-NC 3.0
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GSK Biologicals' Hib-MenCY-TT Conjugate Vaccine vs ActHIB® & MenC Conjugate Licensed Vaccine (NCT00134719)

English

Temperature

1 forms  
  1. StudyEvent: ODM
    1. Temperature
Administrative Data
Description

Administrative Data

Subject Number
Description

Clinical Trial Subject Unique Identifier

Data type

integer

Alias
UMLS CUI [1]
C2348585
Temperature within 15 days post-vaccination
Description

Temperature within 15 days post-vaccination

Alias
UMLS CUI-1
C0005903
Fever
Description

Fever

Data type

text

Alias
UMLS CUI [1]
C0015967
Episode No
Description

Body Temperature, Day

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439228
Temperature
Description

Body Temperature

Data type

float

Measurement units
  • °C
Alias
UMLS CUI [1]
C0005903
°C
not taken
Description

Temperature not taken

Data type

boolean

Alias
UMLS CUI [1]
C0437722
If fever -> Causality
Description

Fever, Etiology aspects

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0015127
If fever -> Medically attended visit
Description

Fever, Visit, Medical

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
Temperature in case of suspected fever
Description

Temperature in case of suspected fever

Alias
UMLS CUI-1
C0005903
Episode No
Description

Body Temperature, Day

Data type

text

Alias
UMLS CUI [1,1]
C0005903
UMLS CUI [1,2]
C0439228
Fever
Description

Fever

Data type

text

Alias
UMLS CUI [1]
C0015967
Temperature
Description

Body Temperature

Data type

float

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

Fever, Etiology aspects

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0015127
Medically attended visit
Description

Fever, Visit, Medical

Data type

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0545082
UMLS CUI [1,3]
C1386497
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Similar models

Temperature

1 forms
  1. StudyEvent: ODM
    1. Temperature
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
Clinical Trial Subject Unique Identifier
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Temperature within 15 days post-vaccination
C0005903 (UMLS CUI-1)
Item
Fever
text
C0015967 (UMLS CUI [1])
undefined item
Code List
Fever
CL Item
Axillary > 37.5°C (requested in Protocol)  (1)
CL Item
Rectal > 38°C (2)
Item
Episode No
text
C0005903 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Body Temperature, Day
Code List
Episode No
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
CL Item
Day 4 (5)
CL Item
Day 5 (6)
CL Item
Day 6 (7)
CL Item
Day 7 (8)
CL Item
Day 8 (9)
CL Item
Day 9 (10)
CL Item
Day 10 (11)
CL Item
Day 11 (12)
CL Item
Day 12 (13)
CL Item
Day 13 (14)
CL Item
Day 14 (15)
Body Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Temperature not taken
Item
not taken
boolean
C0437722 (UMLS CUI [1])
Fever, Etiology aspects
Item
If fever -> Causality
boolean
C0015967 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Fever, Visit, Medical
Item
If fever -> Medically attended visit
boolean
C0015967 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
Item Group
Temperature in case of suspected fever
C0005903 (UMLS CUI-1)
Item
Episode No
text
C0005903 (UMLS CUI [1,1])
C0439228 (UMLS CUI [1,2])
Body Temperature, Day
Code List
Episode No
CL Item
Day 15 (1)
CL Item
Day 16 (2)
CL Item
Day 17 (3)
CL Item
Day 18 (4)
CL Item
Day 19 (5)
CL Item
Day 20 (6)
CL Item
Day 21 (7)
CL Item
Day 22 (8)
CL Item
Day 23 (9)
CL Item
Day 24 (10)
CL Item
Day 25 (11)
CL Item
Day 26 (12)
CL Item
Day 27 (13)
CL Item
Day 28 (14)
CL Item
Day 29 (15)
CL Item
Day 30 (16)
CL Item
Day 31 (17)
CL Item
Day 32 (18)
CL Item
Day 33 (19)
CL Item
Day 34 (20)
CL Item
Day 35 (21)
CL Item
Day 36 (22)
CL Item
Day 37 (23)
CL Item
Day 38 (24)
CL Item
Day 39 (25)
CL Item
Day 40 (26)
CL Item
Day 41 (27)
CL Item
Day 42 (28)
Item
Fever
text
C0015967 (UMLS CUI [1])
undefined item
Code List
Fever
CL Item
No (1)
CL Item
Yes (2)
CL Item
Unknown (3)
Body Temperature
Item
Temperature
float
C0005903 (UMLS CUI [1])
Fever, Etiology aspects
Item
Causality
boolean
C0015967 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
Fever, Visit, Medical
Item
Medically attended visit
boolean
C0015967 (UMLS CUI [1,1])
C0545082 (UMLS CUI [1,2])
C1386497 (UMLS CUI [1,3])
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