ID

33387

Descrição

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

Palavras-chave

Versões (1)
  1. 07/12/2018 07/12/2018 -
Titular dos direitos

GSK group of companies

Transferido a

7 de dezembro de 2018

DOI

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Licença

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

Inglês

Contraindications and Elimination Criteria

1 Formulários  
Administrative data
Descrição

Administrative data

Subject Number
Descrição

Subject Number

Tipo de dados

integer

Protocol Number
Descrição

Protocol Number

Tipo de dados

integer

Date of Visit
Descrição

Date of Visit

Tipo de dados

date

Elimination Criteria during the Study
Descrição

Elimination Criteria during the Study

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

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.

Tipo de dados

text

Contraindications to Subsequent Vaccination
Descrição

Contraindications to Subsequent Vaccination

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

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for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator.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.

Tipo de dados

text

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Contraindications and Elimination Criteria

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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