ID

33387

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

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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

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Contraindications and Elimination Criteria

1 Formulaires  
Administrative data
Description

Administrative data

Subject Number
Description

Subject Number

Type de données

integer

Protocol Number
Description

Protocol Number

Type de données

integer

Date of Visit
Description

Date of Visit

Type de données

date

Elimination Criteria during the Study
Description

Elimination Criteria during the Study

The criteria should be checked at each visit subsequent to the first visit.
Description

If any become applicable during the study, it will not require withdrawal of the subject from the study but may determine a subject's evaluability in the according-to-protocol (ATP) analysis.

Type de données

text

Contraindications to Subsequent Vaccination
Description

Contraindications to Subsequent Vaccination

Contraindications to administration of the study vaccines at that point in time
Description

if any one of these AE occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE.

Type de données

text

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Contraindications and Elimination Criteria

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Protocol Number
Item
Protocol Number
integer
Date of Visit
Item
Date of Visit
date
Item Group
Elimination Criteria during the Study
Item
The criteria should be checked at each visit subsequent to the first visit.
text
The criteria should be checked at each visit subsequent to the first visit.
Code List
The criteria should be checked at each visit subsequent to the first visit.
CL Item
Use of any investigational or non-registered product (drug or vaccine) other that the study vaccine(s) during the study period. (1)
CL Item
Chronic administration (defined as more that 14 days) of immunosuppressants or other immune-modifying drugs during the study period. (For corticosteroids, this will mean prednisone, or equivalent, >=0.5 mg/kg/day. Inhaled and topical steroids are allowed.) (2)
CL Item
Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before administration of the study vaccine and ending 30 days after, with the exception of OPV. (3)
CL Item
Administration of immunoglobulins and/or any blood products during the study period. (4)
Item Group
Contraindications to Subsequent Vaccination
Item
Contraindications to administration of the study vaccines at that point in time
text
Contraindications to administration of the study vaccines at that point in time
Code List
Contraindications to administration of the study vaccines at that point in time
CL Item
Acute disease at the time of vaccination: the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. axillary temperature <37.5°C / rectal temperature <38°C. (1)
CL Item
Axillary temperature >= 37.5°C / rectal temperature >=38°C at the time of booster vaccination. (2)
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