ID

33336

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

  1. 6/12/18 6/12/18 -
Titular de derechos de autor

GSK group of companies

Subido en

6 de diciembre de 2018

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY-NC 3.0

Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

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
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Protocol Number
Descripción

Protocol Number

Tipo de datos

integer

Check for Study Continuation
Descripción

Check for Study Continuation

Did the subject return for visit 2?
Descripción

Did the subject return for visit 2?

Tipo de datos

boolean

If yes, please complete all forms for Visit 2
Descripción

If yes, please complete all forms for Visit 2

Tipo de datos

text

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

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

Tipo de datos

text

If SAE, record the SAE number
Descripción

If SAE, record the SAE number

Tipo de datos

integer

If Non-SAE, record the unsolicited AE number
Descripción

If Non-SAE, record the unsolicited AE number

Tipo de datos

integer

If Other, specify
Descripción

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

Tipo de datos

text

Who took the decision?
Descripción

Who took the decision?

Tipo de datos

text

Similar models

Visit 2: Study Continuation Check

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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)

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

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