ID

33244

Beschreibung

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

Stichworte

Versionen (1)
  1. 03.12.18 03.12.18 -
Rechteinhaber

GSK group of companies

Hochgeladen am

3. Dezember 2018

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY-NC 3.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

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

Englisch

Diary card 3: General Symptoms

1 Formulare  
Administrative data
Beschreibung

Administrative data

Subject Number
Beschreibung

Subject Number

Datentyp

integer

Dose
Beschreibung

Dose

Datentyp

text

General Symptoms
Beschreibung

General Symptoms

Day
Beschreibung

Day

Datentyp

integer

Temperature
Beschreibung

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

Datentyp

text

t°
Beschreibung

t°

Datentyp

float

Maßeinheiten
  • °C
°C
Ongoing after Day 7?
Beschreibung

Ongoing after Day 7?

Datentyp

boolean

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

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

Datentyp

date

Medically attended visit?
Beschreibung

Medically attended visit?

Datentyp

boolean

Irritability/Fussiness
Beschreibung

intensity

Datentyp

text

Was the crying continuous?
Beschreibung

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

Datentyp

boolean

Was the crying unaltered ≥ 3 hours?
Beschreibung

Was the crying unaltered ≥ 3 hours?

Datentyp

boolean

Ongoing after Day 7?
Beschreibung

Ongoing after Day 7?

Datentyp

boolean

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

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

Datentyp

date

Medically attended visit?
Beschreibung

Medically attended visit?

Datentyp

boolean

Drowsiness
Beschreibung

intensity

Datentyp

text

Ongoing after Day 7?
Beschreibung

Ongoing after Day 7?

Datentyp

boolean

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

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

Datentyp

date

Medically attended visit?
Beschreibung

Medically attended visit?

Datentyp

boolean

Loss of appetite
Beschreibung

intensity

Datentyp

text

Ongoing after Day 7?
Beschreibung

Ongoing after Day 7?

Datentyp

boolean

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

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

Datentyp

date

Medically attended visit?
Beschreibung

Medically attended visit?

Datentyp

boolean

Vomiting
Beschreibung

Number

Datentyp

integer

Ongoing after Day 7?
Beschreibung

Ongoing after Day 7?

Datentyp

boolean

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

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

Datentyp

date

Medically attended visit?
Beschreibung

Medically attended visit?

Datentyp

boolean

Diarrhea
Beschreibung

number of looser than normal stools

Datentyp

integer

Ongoing after Day 7?
Beschreibung

Ongoing after Day 7?

Datentyp

boolean

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

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

Datentyp

date

Medically attended visit?
Beschreibung

Medically attended visit?

Datentyp

boolean

Reminder
Beschreibung

Reminder

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

Please do not forget to bring back the diary cad on

Datentyp

date

In case of hospitalisation please inform
Beschreibung

In case of hospitalisation please inform

Datentyp

text

Zum Seitenanfang zurückkehren

Ähnliche Modelle

Diary card 3: General Symptoms

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video