ID

27344

Descrição

Study ID: 103534 Clinical Study ID: 103534 Study Title: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00196976 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed clinical study under GSK sponsorship. The product that is studied in this clinical study, together with the rights to the data and results generated, has been transferred by GSK to Pfizer. GSK’s Clinical Study Register is no longer maintained for this study. To request access to clinical study data from Pfizer, go here: http://www.pfizer.com/research/clinical_trials/trial_data_and_results Generic Name: Meningococcal Serogroups A, C, W-135 and Y-Tetanus Toxoid Conjugate Vaccine Trade Name: Nimenrix Study Indication: Infections, Meningococcal Booster Vaccination Only for subjects who are part of the group with the selected MenACWY-TT formulation and the control group.) “Subjects enrolled at 3 – 5 years of age”

Link

http://www.pfizer.com/research/clinical_trials/trial_data_and_results

Palavras-chave

Versões (1)
  1. 08/11/2017 08/11/2017 -
Titular dos direitos

Pfizer

Transferido a

8 de novembro de 2017

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.

Meningococcal Infections Vaccination in children NCT00196976

Inglês

Workbook 2 Study Conclusion Stage 2

1 Formulários  
Administrative Documentation
Descrição

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject Number
Descrição

Subject Number

Tipo de dados

integer

Alias
UMLS CUI [1]
C2348585
Follow-up studies Stage 2
Descrição

Follow-up studies Stage 2

Alias
UMLS CUI-1
C0016441
Would the subject be willing to participate in a follow-up study?
Descrição

Follow-up study participation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0016441
UMLS CUI [1,2]
C2348568
No, please specify the most appropriate reason
Descrição

Follow-up study participation

Tipo de dados

text

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C2348568
STUDY CONCLUSION STAGE 2
Descrição

STUDY CONCLUSION STAGE 2

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
UMLS CUI-3
C0042210
Did any elimination criteria become applicable during the study ?
Descrição

Elimination criteria

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
Did any elimination criteria become applicable during the study? Please specify
Descrição

Elimination criteria

Tipo de dados

text

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1521902
Administrative Documentation
Descrição

Administrative Documentation

Alias
UMLS CUI-1
C1320722
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator's signature:
Descrição

Investigators signature

Tipo de dados

text

Alias
UMLS CUI [1]
C2346576
Date
Descrição

Signature Date

Tipo de dados

date

Alias
UMLS CUI [1]
C0807937
Printed Investigator's name:
Descrição

Printed Investigator's name:

Tipo de dados

text

Alias
UMLS CUI [1]
C2826892
Voltar ao início da página

Similar models

Workbook 2 Study Conclusion Stage 2

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Follow-up studies Stage 2
C0016441 (UMLS CUI-1)
Follow-up study participation
Item
Would the subject be willing to participate in a follow-up study?
boolean
C0016441 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Item
No, please specify the most appropriate reason
text
C3274571 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
Follow-up study participation
Code List
No, please specify the most appropriate reason
CL Item
Adverse Events, or Serious Adverse Events, please specify: (Adverse Events, or Serious Adverse Events, please specify:)
CL Item
Other, please specify: (Other, please specify:)
Item Group
STUDY CONCLUSION STAGE 2
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
C0042210 (UMLS CUI-3)
Elimination criteria
Item
Did any elimination criteria become applicable during the study ?
boolean
C0680251 (UMLS CUI [1])
Elimination criteria
Item
Did any elimination criteria become applicable during the study? Please specify
text
C0680251 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Investigators signature
Item
I confirm that I have reviewed the data in this Case Report Form for this subject. All information entered by myself or my colleagues is, to the best of my knowledge, complete and accurate, as of the date below. Investigator's signature:
text
C2346576 (UMLS CUI [1])
Signature Date
Item
Date
date
C0807937 (UMLS CUI [1])
Printed Investigator's name:
Item
Printed Investigator's name:
text
C2826892 (UMLS CUI [1])
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