ID

33970

Description

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 contains information about the HIV repeat test, that should be performed at visit 6 and is part of amendment 1

Lien

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

Mots-clés

Versions (3)
  1. 31/10/2018 31/10/2018 -
  2. 17/11/2018 17/11/2018 -
  3. 09/01/2019 09/01/2019 -
Détendeur de droits

GlaxoSmithKline

Téléchargé le

9 janvier 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY-NC 3.0
Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Retour au modèle Commentaires
Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644

Anglais

HIV Repeat Test

1 Formulaires  
  1. StudyEvent: ODM
    1. HIV Repeat Test
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Date of visit
Description

Date of visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
Subject number
Description

Subject number

Type de données

integer

Alias
UMLS CUI [1]
C2348585
HIV repeat test
Description

HIV repeat test

Alias
UMLS CUI-1
C1321876
Was a blood sample taken after breast feeding cessation (subject HIV exposed but PCR negative at visit 3) ?
Description

This item is only applicable in visit 6 of amendment 1

Type de données

integer

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0019682
UMLS CUI [2,1]
C0005834
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0006147
UMLS CUI [3,1]
C0854048
UMLS CUI [3,2]
C0032520
UMLS CUI [3,3]
C1512346
Blood sample date
Description

Please fill in only if different from visit date

Type de données

date

Alias
UMLS CUI [1,1]
C0005834
UMLS CUI [1,2]
C0011008
HIV Testing Results (PCR)
Description

HIV Testing Results (PCR)

Type de données

integer

Alias
UMLS CUI [1,1]
C1321876
UMLS CUI [1,2]
C0032520
UMLS CUI [1,3]
C1274040
Retour au début de la page

Similar models

HIV Repeat Test

1 Formulaires
  1. StudyEvent: ODM
    1. HIV Repeat Test
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1320722 (UMLS CUI-1)
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
HIV repeat test
C1321876 (UMLS CUI-1)
Item
Was a blood sample taken after breast feeding cessation (subject HIV exposed but PCR negative at visit 3) ?
integer
C0332157 (UMLS CUI [1,1])
C0019682 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0006147 (UMLS CUI [2,3])
C0854048 (UMLS CUI [3,1])
C0032520 (UMLS CUI [3,2])
C1512346 (UMLS CUI [3,3])
HIV repeat test
Code List
Was a blood sample taken after breast feeding cessation (subject HIV exposed but PCR negative at visit 3) ?
CL Item
Yes (1)
CL Item
No (2)
CL Item
NA (3)
Blood sample date
Item
Blood sample date
date
C0005834 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
HIV Testing Results (PCR)
integer
C1321876 (UMLS CUI [1,1])
C0032520 (UMLS CUI [1,2])
C1274040 (UMLS CUI [1,3])
HIV Testing Results (PCR)
Code List
HIV Testing Results (PCR)
CL Item
Negative (1)
CL Item
Positive (2)
CL Item
Unknown (3)
CL Item
NA (4)
Retour au début de la page 

Contact

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

Aide

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