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
Versions (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
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GSK Biologicals' oral HRV vaccine given with OPV in infants NCT00139334
Gastroenteritis episodes
- StudyEvent: ODM
Description
Gastroenteritis episodes
Alias
- UMLS CUI-1
- C0017160
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
- StudyEvent: ODM
C16696 (NCI Thesaurus ObjectClass)
C25385 (NCI Thesaurus Property)
C1549755 (UMLS CUI [1])