ID

33403

Description

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

Mots-clés

Versions (1)
  1. 07/12/2018 07/12/2018 -
Détendeur de droits

GSK group of companies

Téléchargé le

7 décembre 2018

DOI

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Licence

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

Anglais

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

1 Formulaires  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Type de données

integer

Date of Visit
Description

Date of Visit

Type de données

text

Protocol Number
Description

Protocol Number

Type de données

integer

Solicited Adverse Events - DTPw-HBV Kft vaccine
Description

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?
Description

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

Type de données

text

Local Symptoms - Redness
Description

Local Symptoms - Redness

Day
Description

Day

Type de données

integer

Redness
Description

Redness

Type de données

boolean

If Yes, record the size
Description

If Yes, record the size

Type de données

integer

Unités de mesure
  • mm
mm
Ongoing after day 7?
Description

Ongoing after day 7?

Type de données

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Type de données

date

Medically attended visit
Description

Medically attended visit

Type de données

boolean

If Yes, record the visit type
Description

If Yes, record the visit type

Type de données

text

Local Symptoms - Swelling
Description

Local Symptoms - Swelling

Day
Description

Day

Type de données

integer

Swelling
Description

Swelling

Type de données

boolean

If Yes, record the size
Description

If Yes, record the size

Type de données

integer

Unités de mesure
  • mm
mm
Ongoing after day 7?
Description

Ongoing after day 7?

Type de données

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Type de données

date

Medically attended visit
Description

Medically attended visit

Type de données

boolean

If Yes, record the visit type
Description

If Yes, record the visit type

Type de données

text

Local Symptoms - Pain
Description

Local Symptoms - Pain

Day
Description

Day

Type de données

integer

Pain
Description

Pain

Type de données

boolean

If Yes, record the intensity
Description

If Yes, record the intensity

Type de données

text

Ongoing after day 7?
Description

Ongoing after day 7?

Type de données

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Type de données

date

Medically attended visit
Description

Medically attended visit

Type de données

boolean

If Yes, record the visit type
Description

If Yes, record the visit type

Type de données

text

Solicited Adverse Events - HiberixTM vaccine
Description

Solicited Adverse Events - HiberixTM vaccine

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

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

Type de données

text

Local Symptoms - Redness
Description

Local Symptoms - Redness

Day
Description

Day

Type de données

integer

Redness
Description

Redness

Type de données

boolean

If Yes, record the size
Description

If Yes, record the size

Type de données

integer

Unités de mesure
  • mm
mm
Ongoing after day 7?
Description

Ongoing after day 7?

Type de données

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Type de données

date

Medically attended visit
Description

Medically attended visit

Type de données

boolean

If Yes, record the visit type
Description

If Yes, record the visit type

Type de données

text

Local Symptoms - Swelling
Description

Local Symptoms - Swelling

Day
Description

Day

Type de données

integer

Swelling
Description

Swelling

Type de données

boolean

If Yes, record the size
Description

If Yes, record the size

Type de données

integer

Unités de mesure
  • mm
mm
Ongoing after day 7?
Description

Ongoing after day 7?

Type de données

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Type de données

date

Medically attended visit
Description

Medically attended visit

Type de données

boolean

If Yes, record the visit type
Description

If Yes, record the visit type

Type de données

text

Local Symptoms - Pain
Description

Local Symptoms - Pain

Day
Description

Day

Type de données

text

Pain
Description

Pain

Type de données

boolean

If Yes, record the intensity
Description

If Yes, record the intensity

Type de données

text

Ongoing after day 7?
Description

Ongoing after day 7?

Type de données

boolean

If Yes, record date of last day of symptoms
Description

If Yes, record date of last day of symptoms

Type de données

date

Medically attended visit
Description

Medically attended visit

Type de données

boolean

If Yes, record the visit type
Description

If Yes, record the visit type

Type de données

text

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Similar models

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

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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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