ID

33403

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. 7/12/18 7/12/18 -
Titular de derechos de autor

GSK group of companies

Subido en

7 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 3: Solicited Adverse Events (DTPw-HBV Kft + HiberixTM)

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

text

Protocol Number
Descripción

Protocol Number

Tipo de datos

integer

Solicited Adverse Events - DTPw-HBV Kft vaccine
Descripción

Solicited Adverse Events - DTPw-HBV Kft vaccine

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

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

Tipo de datos

text

Local Symptoms - Redness
Descripción

Local Symptoms - Redness

Day
Descripción

Day

Tipo de datos

integer

Redness
Descripción

Redness

Tipo de datos

boolean

If Yes, record the size
Descripción

If Yes, record the size

Tipo de datos

integer

Unidades de medida
  • mm
mm
Ongoing after day 7?
Descripción

Ongoing after day 7?

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

If Yes, record the visit type
Descripción

If Yes, record the visit type

Tipo de datos

text

Local Symptoms - Swelling
Descripción

Local Symptoms - Swelling

Day
Descripción

Day

Tipo de datos

integer

Swelling
Descripción

Swelling

Tipo de datos

boolean

If Yes, record the size
Descripción

If Yes, record the size

Tipo de datos

integer

Unidades de medida
  • mm
mm
Ongoing after day 7?
Descripción

Ongoing after day 7?

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

If Yes, record the visit type
Descripción

If Yes, record the visit type

Tipo de datos

text

Local Symptoms - Pain
Descripción

Local Symptoms - Pain

Day
Descripción

Day

Tipo de datos

integer

Pain
Descripción

Pain

Tipo de datos

boolean

If Yes, record the intensity
Descripción

If Yes, record the intensity

Tipo de datos

text

Ongoing after day 7?
Descripción

Ongoing after day 7?

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

If Yes, record the visit type
Descripción

If Yes, record the visit type

Tipo de datos

text

Solicited Adverse Events - HiberixTM vaccine
Descripción

Solicited Adverse Events - HiberixTM vaccine

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

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

Tipo de datos

text

Local Symptoms - Redness
Descripción

Local Symptoms - Redness

Day
Descripción

Day

Tipo de datos

integer

Redness
Descripción

Redness

Tipo de datos

boolean

If Yes, record the size
Descripción

If Yes, record the size

Tipo de datos

integer

Unidades de medida
  • mm
mm
Ongoing after day 7?
Descripción

Ongoing after day 7?

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

If Yes, record the visit type
Descripción

If Yes, record the visit type

Tipo de datos

text

Local Symptoms - Swelling
Descripción

Local Symptoms - Swelling

Day
Descripción

Day

Tipo de datos

integer

Swelling
Descripción

Swelling

Tipo de datos

boolean

If Yes, record the size
Descripción

If Yes, record the size

Tipo de datos

integer

Unidades de medida
  • mm
mm
Ongoing after day 7?
Descripción

Ongoing after day 7?

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

If Yes, record the visit type
Descripción

If Yes, record the visit type

Tipo de datos

text

Local Symptoms - Pain
Descripción

Local Symptoms - Pain

Day
Descripción

Day

Tipo de datos

text

Pain
Descripción

Pain

Tipo de datos

boolean

If Yes, record the intensity
Descripción

If Yes, record the intensity

Tipo de datos

text

Ongoing after day 7?
Descripción

Ongoing after day 7?

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

If Yes, record the visit type
Descripción

If Yes, record the visit type

Tipo de datos

text

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Similar models

Visit 3: Solicited Adverse Events (DTPw-HBV Kft + HiberixTM)

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
text
Protocol Number
Item
Protocol Number
integer
Item Group
Solicited Adverse Events - DTPw-HBV Kft vaccine
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes (please tick No/Yes for each symptom) (4)
Item Group
Local Symptoms - Redness
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)
Redness
Item
Redness
boolean
If Yes, record the size
Item
If Yes, record the size
integer
Ongoing after day 7?
Item
Ongoing after day 7?
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
If Yes, record the visit type
text
If Yes, record the visit type
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
Item Group
Local Symptoms - Swelling
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)
Swelling
Item
Swelling
boolean
If Yes, record the size
Item
If Yes, record the size
integer
Ongoing after day 7?
Item
Ongoing after day 7?
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
If Yes, record the visit type
text
If Yes, record the visit type
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
Item Group
Local Symptoms - Pain
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)
Pain
Item
Pain
boolean
Item
If Yes, record the intensity
text
If Yes, record the intensity
Code List
If Yes, record the intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after day 7?
Item
Ongoing after day 7?
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
If Yes, record the visit type
text
If Yes, record the visit type
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
Item Group
Solicited Adverse Events - HiberixTM vaccine
Item
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
text
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
Code List
Has the subject experienced any of the following signs/symptoms at the administration site during the solicited period?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes (please tick No/Yes for each symptom) (4)
Item Group
Local Symptoms - Redness
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)
Redness
Item
Redness
boolean
If Yes, record the size
Item
If Yes, record the size
integer
Ongoing after day 7?
Item
Ongoing after day 7?
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
If Yes, record the visit type
text
If Yes, record the visit type
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
Item Group
Local Symptoms - Swelling
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)
Swelling
Item
Swelling
boolean
If Yes, record the size
Item
If Yes, record the size
integer
Ongoing after day 7?
Item
Ongoing after day 7?
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
If Yes, record the visit type
text
If Yes, record the visit type
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
Item Group
Local Symptoms - Pain
Item
Day
text
Day
Code List
Day
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2 (3)
CL Item
Day 3 (4)
Pain
Item
Pain
boolean
Item
If Yes, record the intensity
text
If Yes, record the intensity
Code List
If Yes, record the intensity
CL Item
None (1)
CL Item
Mild (2)
CL Item
Moderate (3)
CL Item
Severe (4)
Ongoing after day 7?
Item
Ongoing after day 7?
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
If Yes, record the visit type
text
If Yes, record the visit type
Code List
If Yes, record the visit type
CL Item
Hospitalisation (1)
CL Item
Emergency room (2)
CL Item
Medical personnel (3)
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