ID

33462

Descripción

Study ID: 104065 Clinical Study ID: 104065 Study Title: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immuno & reacto of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00169442  Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completet Generic Name: Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine (KFT) Trade Name: Zilbrix/Hib Study Indication: Diphtheria; Haemophilus influenzae type b; Hepatitis B; Tetanus; Whole Cell Pertussis

Palabras clave

Versiones (1)
  1. 10/12/18 10/12/18 -
Titular de derechos de autor

GSK group of companies

Subido en

10 de diciembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0
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Immune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

Inglés

Visit 4: Solicited Adverse Events - General Symptoms

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Date of Visit
Descripción

Date of Visit

Tipo de datos

date

Protocol Number
Descripción

Protocol Number

Tipo de datos

integer

Solicited Adverse Events
Descripción

Solicited Adverse Events

Has the subject experienced any of the following signs/symptoms during the solicited period?
Descripción

Has the subject experienced any of the following signs/symptoms during the solicited period?

Tipo de datos

text

Fever
Descripción

Fever

Day
Descripción

Day

Tipo de datos

integer

Fever
Descripción

Fever

Tipo de datos

boolean

If Yes, record t°
Descripción

If Yes, record t°

Tipo de datos

float

Unidades de medida
  • °C
°C
record route
Descripción

record route

Tipo de datos

text

Ongoing after days 7?
Descripción

Ongoing after days 7?

Tipo de datos

boolean

Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Causality
Descripción

Causality

Tipo de datos

boolean

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

Visit type
Descripción

Visit type

Tipo de datos

text

Irritability/Fussiness
Descripción

Irritability/Fussiness

Day
Descripción

Day

Tipo de datos

integer

Irritability/Fussiness
Descripción

Irritability/Fussiness

Tipo de datos

boolean

If Yes, record intensity
Descripción

If Yes, record intensity

Tipo de datos

text

Ongoing after days 7?
Descripción

Ongoing after days 7?

Tipo de datos

boolean

Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Causality
Descripción

Causality

Tipo de datos

boolean

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

Visit type
Descripción

Visit type

Tipo de datos

text

Drowsiness
Descripción

Drowsiness

Day
Descripción

Day

Tipo de datos

integer

Drowsiness
Descripción

Drowsiness

Tipo de datos

boolean

If Yes, record intensity
Descripción

If Yes, record intensity

Tipo de datos

text

Ongoing after days 7?
Descripción

Ongoing after days 7?

Tipo de datos

boolean

Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Causality
Descripción

Causality

Tipo de datos

boolean

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

Visit type
Descripción

Visit type

Tipo de datos

text

Loss of Appetite
Descripción

Loss of Appetite

Day
Descripción

Day

Tipo de datos

integer

Loss of Appetite
Descripción

Loss of Appetite

Tipo de datos

boolean

If Yes, record intensity
Descripción

If Yes, record intensity

Tipo de datos

text

Ongoing after days 7?
Descripción

Ongoing after days 7?

Tipo de datos

boolean

Date of last day of symptoms
Descripción

Date of last day of symptoms

Tipo de datos

date

Causality
Descripción

Causality

Tipo de datos

boolean

Medically attended visit
Descripción

Medically attended visit

Tipo de datos

boolean

Visit type
Descripción

Visit type

Tipo de datos

text

In case of "Severe" Intensity of Crying:
Descripción

In case of "Severe" Intensity of Crying:

Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?
Descripción

Was the crying continuous (i.r. not episodec, not interrupted within the 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

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Similar models

Visit 4: Solicited Adverse Events - 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
Date of Visit
Item
Date of Visit
date
Protocol Number
Item
Protocol Number
integer
Item Group
Solicited Adverse Events
Item
Has the subject experienced any of the following signs/symptoms during the solicited period?
text
Has the subject experienced any of the following signs/symptoms during the solicited period?
Code List
Has the subject experienced any of the following signs/symptoms during the solicited period?
CL Item
Information not available (1)
CL Item
No vaccine administered (2)
CL Item
No (3)
CL Item
Yes (please complete the form below) (4)
Item Group
Fever
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)
Fever
Item
Fever
boolean
If Yes, record t°
Item
If Yes, record t°
float
Item
record route
text
record route
Code List
record route
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Tympanic oral (3)
CL Item
Tympanic rectal (4)
CL Item
Rectal (5)
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Visit type
text
Visit type
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Irritability/Fussiness
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)
Irritability/Fussiness
Item
Irritability/Fussiness
boolean
Item
If Yes, record intensity
text
If Yes, record intensity
Code List
If Yes, record intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Visit type
text
Visit type
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Drowsiness
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)
Drowsiness
Item
Drowsiness
boolean
Item
If Yes, record intensity
text
If Yes, record intensity
Code List
If Yes, record intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Visit type
text
Visit type
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
Loss of Appetite
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)
Loss of Appetite
Item
Loss of Appetite
boolean
Item
If Yes, record intensity
text
If Yes, record intensity
Code List
If Yes, record intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after days 7?
Item
Ongoing after days 7?
boolean
Date of last day of symptoms
Item
Date of last day of symptoms
date
Causality
Item
Causality
boolean
Medically attended visit
Item
Medically attended visit
boolean
Item
Visit type
text
Visit type
Code List
Visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical Personnel (3)
Item Group
In case of "Severe" Intensity of Crying:
Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?
Item
Was the crying continuous (i.r. not episodec, not interrupted within the time period of 3 hours by e.g. naps)?
boolean
Was the crying unaltered >=3 hours?
Item
Was the crying unaltered >=3 hours?
boolean
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