ID

33336

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

  1. 06/12/2018 06/12/2018 -
Titular dos direitos

GSK group of companies

Transferido a

6 de dezembro de 2018

DOI

Para um pedido faça login.

Licença

Creative Commons BY-NC 3.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

mmune memory of Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b Vaccine at infants (15 to 18 mths) - 104065

Visit 2: Study Continuation Check

Administrative data
Descrição

Administrative data

Subject Number
Descrição

Subject Number

Tipo de dados

integer

Protocol Number
Descrição

Protocol Number

Tipo de dados

integer

Check for Study Continuation
Descrição

Check for Study Continuation

Did the subject return for visit 2?
Descrição

Did the subject return for visit 2?

Tipo de dados

boolean

If yes, please complete all forms for Visit 2
Descrição

If yes, please complete all forms for Visit 2

Tipo de dados

text

If No, record ONE most appropriate reason and skip the following pages of this visit
Descrição

If No, record ONE most appropriate reason and skip the following pages of this visit

Tipo de dados

text

If SAE, record the SAE number
Descrição

If SAE, record the SAE number

Tipo de dados

integer

If Non-SAE, record the unsolicited AE number
Descrição

If Non-SAE, record the unsolicited AE number

Tipo de dados

integer

If Other, specify
Descrição

e.g., consent withdrawal, protocol violation, etc.

Tipo de dados

text

Who took the decision?
Descrição

Who took the decision?

Tipo de dados

text

Similar models

Visit 2: Study Continuation Check

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
Item Group
Check for Study Continuation
Did the subject return for visit 2?
Item
Did the subject return for visit 2?
boolean
If yes, please complete all forms for Visit 2
Item
If yes, please complete all forms for Visit 2
text
Item
If No, record ONE most appropriate reason and skip the following pages of this visit
text
Code List
If No, record ONE most appropriate reason and skip the following pages of this visit
CL Item
Serious Adverse Event (1)
CL Item
Non-Serious adverse event (2)
CL Item
Other (3)
If SAE, record the SAE number
Item
If SAE, record the SAE number
integer
If Non-SAE, record the unsolicited AE number
Item
If Non-SAE, record the unsolicited AE number
integer
If Other, specify
Item
If Other, specify
text
Item
Who took the decision?
text
Code List
Who took the decision?
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial