ID
32437
Descrizione
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 a blood sample has been taken from the patient and should be checked at visit 1.
collegamento
https://clinicaltrials.gov/ct2/show/NCT00241644
Keywords
versioni (1)
- 01/11/18 01/11/18 -
Titolare del copyright
GlaxoSmithKline
Caricato su
1 novembre 2018
DOI
Per favore, per richiedere un accesso.
Licenza
Creative Commons BY-NC 3.0
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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644
Laboratory Tests Visit 1
- StudyEvent: ODM
Descrizione
Laboratory Tests
Alias
- UMLS CUI-1
- C0022885
Descrizione
2 ml in South Africa and 1 ml in Malawi for subset only (Amendment 4)
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0005834
Descrizione
Please complete only if different from visit date:
Tipo di dati
text
Alias
- UMLS CUI [1,1]
- C0005834
- UMLS CUI [1,2]
- C0011008
Descrizione
Medical History for HIV
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0019682
Descrizione
Subject exposed to HIV
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0019682
- UMLS CUI [1,2]
- C0332157
Descrizione
If yes, complete the specific HIV section.
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C1321876
- UMLS CUI [1,2]
- C0262926
Similar models
Laboratory Tests Visit 1
- StudyEvent: ODM
C0011008 (UMLS CUI [1,2])
C0019682 (UMLS CUI-2)
C0332157 (UMLS CUI [1,2])
C0262926 (UMLS CUI [1,2])