ID

32630

Descrição

Study ID: 102248 Clinical Study ID: 102248 Study Title: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00241644 Study Link: https://clinicaltrials.gov/ct2/show/NCT00241644 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Infections, Rotavirus The visits are defined as follows: Visit 1: (Study/Participation) Day 0, Age: 5-10 weeks, Dose 1 Visit 2: (Study/Participation) Month 1, 30-48 days after Visit 1, Dose 2 Visit 3: (Study/Participation) Month 2, 30-48 days after Visit 2, Dose 3 Visit 4: (Study/Participation) Month 3, 30-48 days after Visit 3, Visit 5: (Study/Participation) 1 year of age, 343-391 days of age For amendment 5: Visit 5: (Study/Participation) 21-48 days after Visit 4 Visit 6: (Study/Participation) 1 year of age, 343-391 days of age This form asks, if and when routine vaccine administrations have taken place and should be checked at visits 1-3.

Link

https://clinicaltrials.gov/ct2/show/NCT00241644

Palavras-chave

Versões (2)
  1. 01/11/2018 01/11/2018 -
  2. 09/11/2018 09/11/2018 - Sarah Riepenhausen
Titular dos direitos

GlaxoSmithKline

Transferido a

9 de novembro 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.

Voltar para os comentários do modelo
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.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

Inglês

Routine Vaccine Administration

1 Formulários  
Administrative Data
Descrição

Administrative Data

Alias
UMLS CUI-1
C1320722
Visit number
Descrição

Visit number

Tipo de dados

integer

Alias
UMLS CUI [1]
C1549755
Date of visit
Descrição

Date of visit

Tipo de dados

date

Alias
UMLS CUI [1]
C1320303
Subject number
Descrição

Subject number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Routine Vaccine Administrations
Descrição

Routine Vaccine Administrations

Alias
UMLS CUI-1
C2368628
UMLS CUI-2
C0205547
OPV Vaccination
Descrição

If Yes is ticked, the above vaccines are not to be reported again in the Concomitant Vaccination section at the end of the CRF. Any other vaccines administered during the study period are to be recorded in the Concomitant Vaccination section at the end of the CRF.

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032375
OPV Vaccination administration date if different from visit date:
Descrição

OPV Vaccination Date

Tipo de dados

date

Alias
UMLS CUI [1,1]
C0032375
UMLS CUI [1,2]
C0011008
DTPw-HB/Hib vaccination
Descrição

If Yes is ticked, the above vaccines are not to be reported again in the Concomitant Vaccination section at the end of the CRF. Any other vaccines administered during the study period are to be recorded in the Concomitant Vaccination section at the end of the CRF.

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2240392
UMLS CUI [1,2]
C3653328
UMLS CUI [1,3]
C0012559
DTPw-HB/Hib vaccination administration date if different from visit date:
Descrição

DTPw-HB/Hib vaccination Date

Tipo de dados

text

Alias
UMLS CUI [1,1]
C2240392
UMLS CUI [1,2]
C3653328
UMLS CUI [1,3]
C0012559
UMLS CUI [1,4]
C1115436
Voltar ao início da página

Similar models

Routine Vaccine Administration

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1320722 (UMLS CUI-1)
Item
Visit number
integer
C1549755 (UMLS CUI [1])
Visit number
Code List
Visit number
CL Item
Visit 1 (1)
CL Item
Visit 2 (2)
CL Item
Visit 3 (3)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Routine Vaccine Administrations
C2368628 (UMLS CUI-1)
C0205547 (UMLS CUI-2)
OPV Vaccination
Item
OPV Vaccination
boolean
C0032375 (UMLS CUI [1])
OPV Vaccination Date
Item
OPV Vaccination administration date if different from visit date:
date
C0032375 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
DTPw-HB/Hib vaccination
Item
DTPw-HB/Hib vaccination
boolean
C2240392 (UMLS CUI [1,1])
C3653328 (UMLS CUI [1,2])
C0012559 (UMLS CUI [1,3])
DTPw-HB/Hib vaccination Date
Item
DTPw-HB/Hib vaccination administration date if different from visit date:
text
C2240392 (UMLS CUI [1,1])
C3653328 (UMLS CUI [1,2])
C0012559 (UMLS CUI [1,3])
C1115436 (UMLS CUI [1,4])
Voltar ao início da página 

Contacto

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

Campos marcados com * são obrigatórios.

Ajuda

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