ID

33244

Descripción

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

Palabras clave

Versiones (1)
  1. 3/12/18 3/12/18 -
Titular de derechos de autor

GSK group of companies

Subido en

3 de diciembre de 2018

DOI

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Licencia

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

Inglés

Diary card 3: General Symptoms

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Dose
Descripción

Dose

Tipo de datos

text

General Symptoms
Descripción

General Symptoms

Day
Descripción

Day

Tipo de datos

integer

Temperature
Descripción

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

Tipo de datos

text

t°
Descripción

t°

Tipo de datos

float

Unidades de medida
  • °C
°C
Ongoing after Day 7?
Descripción

Ongoing after Day 7?

Tipo de datos

boolean

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

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

Tipo de datos

date

Medically attended visit?
Descripción

Medically attended visit?

Tipo de datos

boolean

Irritability/Fussiness
Descripción

intensity

Tipo de datos

text

Was the crying continuous?
Descripción

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

Tipo de datos

boolean

Was the crying unaltered ≥ 3 hours?
Descripción

Was the crying unaltered ≥ 3 hours?

Tipo de datos

boolean

Ongoing after Day 7?
Descripción

Ongoing after Day 7?

Tipo de datos

boolean

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

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

Tipo de datos

date

Medically attended visit?
Descripción

Medically attended visit?

Tipo de datos

boolean

Drowsiness
Descripción

intensity

Tipo de datos

text

Ongoing after Day 7?
Descripción

Ongoing after Day 7?

Tipo de datos

boolean

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

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

Tipo de datos

date

Medically attended visit?
Descripción

Medically attended visit?

Tipo de datos

boolean

Loss of appetite
Descripción

intensity

Tipo de datos

text

Ongoing after Day 7?
Descripción

Ongoing after Day 7?

Tipo de datos

boolean

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

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

Tipo de datos

date

Medically attended visit?
Descripción

Medically attended visit?

Tipo de datos

boolean

Vomiting
Descripción

Number

Tipo de datos

integer

Ongoing after Day 7?
Descripción

Ongoing after Day 7?

Tipo de datos

boolean

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

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

Tipo de datos

date

Medically attended visit?
Descripción

Medically attended visit?

Tipo de datos

boolean

Diarrhea
Descripción

number of looser than normal stools

Tipo de datos

integer

Ongoing after Day 7?
Descripción

Ongoing after Day 7?

Tipo de datos

boolean

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

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

Tipo de datos

date

Medically attended visit?
Descripción

Medically attended visit?

Tipo de datos

boolean

Reminder
Descripción

Reminder

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

Please do not forget to bring back the diary cad on

Tipo de datos

date

In case of hospitalisation please inform
Descripción

In case of hospitalisation please inform

Tipo de datos

text

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Similar models

Diary card 3: General Symptoms

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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