ID

33185

Descripción

Study ID: 104021 Clinical Study ID: 104021 Study Title: A phase III, partially blind, randomized study to evaluate the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ Tritanrix™-HepB and GSK Biologicals Kft’s DTPw-HBV vaccines as compared to concomitant administration of Commonwealth Serum Laboratory’s (CSL’s) DTPw (Triple Antigen™) and GSK Biologicals’ HBV (Engerix™-B), when co-administered with GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, to healthy infants at 3, 4½ and 6 months of age, after a birth dose of hepatitis B vaccine. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00158756 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Hepatitis B Vaccine, Recombinant Trade Name: Engerix B Study Indication: Hepatitis B

Palabras clave

Versiones (2)
  1. 30/11/18 30/11/18 -
  2. 30/11/18 30/11/18 -
Titular de derechos de autor

GSK group of companies

Subido en

30 de noviembre 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.

Volver a los comentarios del modelo
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.

Immunogenicity of co-administration of Tritanrix™-HepB and DTPw-HBV vaccines or Triple Antigen™ and Engerix™-B with HRV vaccine to infants (3, 4½ and 6 month) - 104021

Inglés

Visit 4: Study Continuation Check

1 formularios  
Administrative data
Descripción

Administrative data

Subject Number
Descripción

Subject Number

Tipo de datos

integer

Check for Study Continuation
Descripción

Check for Study Continuation

Did the subject return for visit 4?
Descripción

Did the subject return for visit 4?

Tipo de datos

boolean

If yes, please complete all forms for Visit 4
Descripción

If yes, please complete all forms for Visit 4

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

Volver a la parte superior de la página

Similar models

Visit 4: Study Continuation Check

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Item Group
Check for Study Continuation
Did the subject return for visit 4?
Item
Did the subject return for visit 4?
boolean
If yes, please complete all forms for Visit 4
Item
If yes, please complete all forms for Visit 4
text
Item
If No, record ONE most appropriate reason and skip the following pages of this visit
text
If No, record ONE most appropriate reason and skip the following pages of this visit
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
Who took the decision?
Code List
Who took the decision?
CL Item
Investigator (1)
CL Item
Parents/Guardians (2)
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

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