ID

33238

Description

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

Keywords

Versions (1)
  1. 12/3/18 12/3/18 -
Copyright Holder

GSK group of companies

Uploaded on

December 3, 2018

DOI

To request one please log in.

License

Creative Commons BY-NC 3.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

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

English

Diary card 2: General Symptoms

1 forms  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Data type

integer

Dose
Description

Dose

Data type

text

General Symptoms
Description

General Symptoms

Day
Description

Day

Data type

integer

Temperature
Description

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

Data type

text

t°
Description

t°

Data type

float

Measurement units
  • °C
°C
Ongoing after Day 7?
Description

Ongoing after Day 7?

Data type

boolean

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

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

Data type

date

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

Irritability/Fussiness
Description

intensity

Data type

text

Was the crying continuous?
Description

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

Data type

boolean

Was the crying unaltered ≥ 3 hours?
Description

Was the crying unaltered ≥ 3 hours?

Data type

boolean

Ongoing after Day 7?
Description

Ongoing after Day 7?

Data type

boolean

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

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

Data type

date

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

Drowsiness
Description

intensity

Data type

text

Ongoing after Day 7?
Description

Ongoing after Day 7?

Data type

boolean

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

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

Data type

date

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

Loss of appetite
Description

intensity

Data type

text

Ongoing after Day 7?
Description

Ongoing after Day 7?

Data type

boolean

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

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

Data type

date

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

Vomiting
Description

Number

Data type

integer

Ongoing after Day 7?
Description

Ongoing after Day 7?

Data type

boolean

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

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

Data type

date

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

Diarrhea
Description

number of looser than normal stools

Data type

integer

Ongoing after Day 7?
Description

Ongoing after Day 7?

Data type

boolean

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

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

Data type

date

Medically attended visit?
Description

Medically attended visit?

Data type

boolean

Reminder
Description

Reminder

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

Please do not forget to bring back the diary cad on

Data type

date

In case of hospitalisation please inform
Description

In case of hospitalisation please inform

Data type

text

Back to the top of the page

Similar models

Diary card 2: General Symptoms

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Dose
text
Dose
Code List
Dose
CL Item
Dose 2 (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
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial