ID

33244

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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

Nyckelord

Versioner (1)
  1. 2018-12-03 2018-12-03 -
Rättsinnehavare

GSK group of companies

Uppladdad den

3 december 2018

DOI

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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

Engelsk

Diary card 3: General Symptoms

1 Formulär  
Administrative data
Beskrivning

Administrative data

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Dose
Beskrivning

Dose

Datatyp

text

General Symptoms
Beskrivning

General Symptoms

Day
Beskrivning

Day

Datatyp

integer

Temperature
Beskrivning

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

Datatyp

text

t°
Beskrivning

t°

Datatyp

float

Måttenheter
  • °C
°C
Ongoing after Day 7?
Beskrivning

Ongoing after Day 7?

Datatyp

boolean

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

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

Datatyp

date

Medically attended visit?
Beskrivning

Medically attended visit?

Datatyp

boolean

Irritability/Fussiness
Beskrivning

intensity

Datatyp

text

Was the crying continuous?
Beskrivning

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

Datatyp

boolean

Was the crying unaltered ≥ 3 hours?
Beskrivning

Was the crying unaltered ≥ 3 hours?

Datatyp

boolean

Ongoing after Day 7?
Beskrivning

Ongoing after Day 7?

Datatyp

boolean

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

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

Datatyp

date

Medically attended visit?
Beskrivning

Medically attended visit?

Datatyp

boolean

Drowsiness
Beskrivning

intensity

Datatyp

text

Ongoing after Day 7?
Beskrivning

Ongoing after Day 7?

Datatyp

boolean

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

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

Datatyp

date

Medically attended visit?
Beskrivning

Medically attended visit?

Datatyp

boolean

Loss of appetite
Beskrivning

intensity

Datatyp

text

Ongoing after Day 7?
Beskrivning

Ongoing after Day 7?

Datatyp

boolean

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

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

Datatyp

date

Medically attended visit?
Beskrivning

Medically attended visit?

Datatyp

boolean

Vomiting
Beskrivning

Number

Datatyp

integer

Ongoing after Day 7?
Beskrivning

Ongoing after Day 7?

Datatyp

boolean

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

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

Datatyp

date

Medically attended visit?
Beskrivning

Medically attended visit?

Datatyp

boolean

Diarrhea
Beskrivning

number of looser than normal stools

Datatyp

integer

Ongoing after Day 7?
Beskrivning

Ongoing after Day 7?

Datatyp

boolean

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

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

Datatyp

date

Medically attended visit?
Beskrivning

Medically attended visit?

Datatyp

boolean

Reminder
Beskrivning

Reminder

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

Please do not forget to bring back the diary cad on

Datatyp

date

In case of hospitalisation please inform
Beskrivning

In case of hospitalisation please inform

Datatyp

text

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Similar models

Diary card 3: General Symptoms

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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