ID

33472

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

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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

Diary Card: Local Symptoms (DTPw-HBV/Hib Kft)

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Visit
Descripción

Visit

Tipo de datos

text

Protocol Number
Descripción

Protocol Number

Tipo de datos

integer

Local Symptoms - Redness (at injection site)
Descripción

Local Symptoms - Redness (at injection site)

Day
Descripción

Day

Tipo de datos

integer

Size
Descripción

please measure the greatest diameter

Tipo de datos

integer

Unidades de medida
  • mm
mm
Ongoing after Day 3?
Descripción

Ongoing after Day 3?

Tipo de datos

boolean

If Yes, record date of last day of symptoms
Descripción

If Yes, record date of last day of symptoms

Tipo de datos

date

Medical attended visit?
Descripción

Medical attended visit?

Tipo de datos

boolean

Local Symptoms - Swelling (at injection site)
Descripción

Local Symptoms - Swelling (at injection site)

Day
Descripción

Day

Tipo de datos

integer

Size
Descripción

please measure the greatest diameter

Tipo de datos

integer

Unidades de medida
  • mm
mm
Ongoing after Day 3?
Descripción

Ongoing after Day 3?

Tipo de datos

boolean

If Yes, record date of last day of symptoms
Descripción

If Yes, record date of last day of symptoms

Tipo de datos

date

Medical attended visit?
Descripción

Medical attended visit?

Tipo de datos

boolean

Local Symptoms - Pain (at injection site)
Descripción

Local Symptoms - Pain (at injection site)

Day
Descripción

Day

Tipo de datos

integer

Intensity
Descripción

Intensity

Tipo de datos

integer

Ongoing after day 3?
Descripción

Ongoing after day 3?

Tipo de datos

boolean

If Yes, record date of last day of symptoms
Descripción

If Yes, record date of last day of symptoms

Tipo de datos

date

Medically attended visit?
Descripción

Medically attended visit?

Tipo de datos

boolean

Other Local Symptoms
Descripción

Other Local Symptoms

Description
Descripción

please specify side(s) and site(s)

Tipo de datos

text

Intensity
Descripción

Intensity

Tipo de datos

text

Start date
Descripción

Start date

Tipo de datos

date

End date
Descripción

End date

Tipo de datos

date

Ongoing?
Descripción

Ongoing?

Tipo de datos

boolean

Medically attended visit?
Descripción

Medically attended visit?

Tipo de datos

boolean

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Similar models

Diary Card: Local Symptoms (DTPw-HBV/Hib Kft)

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item
Visit
text
Visit
Code List
Visit
CL Item
Vaccination 1 (1)
Protocol Number
Item
Protocol Number
integer
Item Group
Local Symptoms - Redness (at injection site)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (evening) (2)
CL Item
Day 2 (evening) (3)
CL Item
Day 3 (evening) (4)
Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medical attended visit?
Item
Medical attended visit?
boolean
Item Group
Local Symptoms - Swelling (at injection site)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (evening) (2)
CL Item
Day 2 (evening) (3)
CL Item
Day 3 (evening) (4)
Size
Item
Size
integer
Ongoing after Day 3?
Item
Ongoing after Day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medical attended visit?
Item
Medical attended visit?
boolean
Item Group
Local Symptoms - Pain (at injection site)
Item
Day
integer
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (evening) (2)
CL Item
Day 2 (evening) (3)
CL Item
Day 3 (evening) (4)
Item
Intensity
integer
Intensity
Code List
Intensity
CL Item
Absent (1)
CL Item
Minor reaction to touch (2)
CL Item
Cries/protests on touch (3)
CL Item
Cries when limb is moved/spontaneously painful (4)
Ongoing after day 3?
Item
Ongoing after day 3?
boolean
If Yes, record date of last day of symptoms
Item
If Yes, record date of last day of symptoms
date
Medically attended visit?
Item
Medically attended visit?
boolean
Item Group
Other Local Symptoms
Description
Item
Description
text
Item
Intensity
text
Intensity
Code List
Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date
Item
Start date
date
End date
Item
End date
date
Ongoing?
Item
Ongoing?
boolean
Medically attended visit?
Item
Medically attended visit?
boolean
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