ID

33244

Beschrijving

Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

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Versies (1)
  1. 03-12-18 03-12-18 -
Houder van rechten

GSK group of companies

Geüploaded op

3 december 2018

DOI

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Licentie

Creative Commons BY-NC 3.0
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Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021

Engels

Diary card 3: General Symptoms

1 Formulieren  
Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Dose
Beschrijving

Dose

Datatype

text

General Symptoms
Beschrijving

General Symptoms

Day
Beschrijving

Day

Datatype

integer

Temperature
Beschrijving

please record the temperature every day; if temperature has been taken more than once a day, please report the highest value for the day

Datatype

text

t°
Beschrijving

t°

Datatype

float

Maateenheden
  • °C
°C
Ongoing after Day 7?
Beschrijving

Ongoing after Day 7?

Datatype

boolean

If Yes, record the last date of last day of symptoms
Beschrijving

If Yes, record the last date of last day of symptoms

Datatype

date

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

Irritability/Fussiness
Beschrijving

intensity

Datatype

text

Was the crying continuous?
Beschrijving

If crying prevents normal activity or cannot be comforted; continuous->not episodic, not interrupted within time period of 3 hours by e.g. naps

Datatype

boolean

Was the crying unaltered ≥ 3 hours?
Beschrijving

Was the crying unaltered ≥ 3 hours?

Datatype

boolean

Ongoing after Day 7?
Beschrijving

Ongoing after Day 7?

Datatype

boolean

If Yes, record the last date of last day of symptoms
Beschrijving

If Yes, record the last date of last day of symptoms

Datatype

date

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

Drowsiness
Beschrijving

intensity

Datatype

text

Ongoing after Day 7?
Beschrijving

Ongoing after Day 7?

Datatype

boolean

If Yes, record the last date of last day of symptoms
Beschrijving

If Yes, record the last date of last day of symptoms

Datatype

date

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

Loss of appetite
Beschrijving

intensity

Datatype

text

Ongoing after Day 7?
Beschrijving

Ongoing after Day 7?

Datatype

boolean

If Yes, record the last date of last day of symptoms
Beschrijving

If Yes, record the last date of last day of symptoms

Datatype

date

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

Vomiting
Beschrijving

Number

Datatype

integer

Ongoing after Day 7?
Beschrijving

Ongoing after Day 7?

Datatype

boolean

If Yes, record the last date of last day of symptoms
Beschrijving

If Yes, record the last date of last day of symptoms

Datatype

date

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

Diarrhea
Beschrijving

number of looser than normal stools

Datatype

integer

Ongoing after Day 7?
Beschrijving

Ongoing after Day 7?

Datatype

boolean

If Yes, record the last date of last day of symptoms
Beschrijving

If Yes, record the last date of last day of symptoms

Datatype

date

Medically attended visit?
Beschrijving

Medically attended visit?

Datatype

boolean

Reminder
Beschrijving

Reminder

Please do not forget to bring back the diary cad on
Beschrijving

Please do not forget to bring back the diary cad on

Datatype

date

In case of hospitalisation please inform
Beschrijving

In case of hospitalisation please inform

Datatype

text

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Similar models

Diary card 3: General Symptoms

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Dose
text
Dose
Code List
Dose
CL Item
Dose 3 (1)
Item Group
General Symptoms
Item
Day
integer
Day
Code List
Day
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)
Item
Temperature
text
Temperature
Code List
Temperature
CL Item
Axillary (1)
CL Item
Rectal (2)
t°
Item
t°
float
Ongoing after Day 7?
Item
Ongoing after Day 7?
boolean
If Yes, record the last date of last day of symptoms
Item
If Yes, record the last date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Item
Irritability/Fussiness
text
Irritability/Fussiness
Code List
Irritability/Fussiness
CL Item
Behavior as usual (1)
CL Item
Crying more than usual/no effect on normal activity (2)
CL Item
Crying more than usual/interferes with normal activity (3)
CL Item
Crying that cannot be comforted/prevents normal activity (4)
Was the crying continuous?
Item
Was the crying continuous?
boolean
Was the crying unaltered ≥ 3 hours?
Item
Was the crying unaltered ≥ 3 hours?
boolean
Ongoing after Day 7?
Item
Ongoing after Day 7?
boolean
If Yes, record the last date of last day of symptoms
Item
If Yes, record the last date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Item
Drowsiness
text
Drowsiness
Code List
Drowsiness
CL Item
Behavior as usual (1)
CL Item
Drowsiness easily tolerated (2)
CL Item
Drowsiness that interferes with normal activity (3)
CL Item
Drowsiness that prevents normal activity (4)
Ongoing after Day 7?
Item
Ongoing after Day 7?
boolean
If Yes, record the last date of last day of symptoms
Item
If Yes, record the last date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Item
Loss of appetite
text
Loss of appetite
Code List
Loss of appetite
CL Item
Appetite as usual (1)
CL Item
Eating less than usual/no effect on normal activity (2)
CL Item
Eating less than usual/interferes with normal activity (3)
CL Item
Not eating at all (4)
Ongoing after Day 7?
Item
Ongoing after Day 7?
boolean
If Yes, record the last date of last day of symptoms
Item
If Yes, record the last date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Vomiting
Item
Vomiting
integer
Ongoing after Day 7?
Item
Ongoing after Day 7?
boolean
If Yes, record the last date of last day of symptoms
Item
If Yes, record the last date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Diarrhea
Item
Diarrhea
integer
Ongoing after Day 7?
Item
Ongoing after Day 7?
boolean
If Yes, record the last date of last day of symptoms
Item
If Yes, record the last date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Item Group
Reminder
Please do not forget to bring back the diary cad on
Item
Please do not forget to bring back the diary cad on
date
In case of hospitalisation please inform
Item
In case of hospitalisation please inform
text
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