ID

32082

Description

Study ID: 103992 Clinical Study ID: 103992 Study Title: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00139334 https://clinicaltrials.gov/ct2/show/NCT00139334 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: Rotavirus Vaccine Trade Name: Rotarix Study Indication: Haemophilus influenzae type b; Neisseria Meningitidis This form is for documentation of gastroenteritis episodes between visits 3 and 4, 4 and 5 as well as 5 and 6, starting 1 week after dose 1 of HRV/Placebo in Visit 3). To be assessed at Visits 4, 5 and 6. Visit 4 -> Timing: Day 60, Age: 14 weeks +/- 1 week Visit 5 -> Timing: Day 75, Age: 16 weeks +/- 1 week Visit 6 -> Timing: Day 105, Age: 20 weeks +/- 1 week

Lien

https://clinicaltrials.gov/ct2/show/NCT00139334

Mots-clés

  1. 17/10/2018 17/10/2018 - Sarah Riepenhausen
Détendeur de droits

GlaxoSmithKline

Téléchargé le

17 octobre 2018

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.

Groupe Item commentaires pour :

Item commentaires pour :

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

GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334

Gastroenteritis episodes

Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Description

Subject Number

Type de données

text

Alias
UMLS CUI [1]
C2348585
Date of visit
Description

Date of visit

Type de données

date

Alias
UMLS CUI [1]
C1320303
Visit number
Description

Visit number

Type de données

integer

Alias
NCI Thesaurus ValueDomain
C25337
NCI Thesaurus ObjectClass
C16696
NCI Thesaurus Property
C25385
UMLS CUI [1]
C1549755
Gastroenteritis episodes
Description

Gastroenteritis episodes

Alias
UMLS CUI-1
C0017160
Did the subject present diarrhea during the period between this and the preceeding visit (starting from 1 week after Dose 1 or 2 for Visits 4 and 6)?
Description

if yes: please collect a stool sample and report the stools collection date in the gastroenteritis stool collection section. Please fill in the Non-Serious AE or the SAE form.

Type de données

boolean

Alias
UMLS CUI [1]
C0017160

Similar models

Gastroenteritis episodes

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Date of visit
Item
Date of visit
date
C1320303 (UMLS CUI [1])
Item
Visit number
integer
C25337 (NCI Thesaurus ValueDomain)
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
C1549755 (UMLS CUI [1])
Code List
Visit number
CL Item
Visit 4 (4)
CL Item
Visit 5 (5)
CL Item
Visit 6 (6)
Item Group
Gastroenteritis episodes
C0017160 (UMLS CUI-1)
Gastroenteritis episodes
Item
Did the subject present diarrhea during the period between this and the preceeding visit (starting from 1 week after Dose 1 or 2 for Visits 4 and 6)?
boolean
C0017160 (UMLS CUI [1])

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

Les champs marqués d’un * sont obligatoires.

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