ID
32440
Descrição
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 for the general medical history of the patient and the results of a physical examination. It should be checked at first visit.
Link
https://clinicaltrials.gov/ct2/show/NCT00241644
Palavras-chave
Versões (1)
- 01/11/2018 01/11/2018 -
Titular dos direitos
GlaxoSmithKline
Transferido a
1 de novembro de 2018
DOI
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Licença
Creative Commons BY-NC 3.0
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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644
Medical History and Physical Examination
- StudyEvent: ODM
Descrição
General Medical History, Phyiscal Examination
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0031809
Descrição
Pre-existing conditions, signs or symptoms
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0521987
- UMLS CUI [2]
- C0037088
Descrição
MedDRA System Organ Class
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C2347091
Descrição
Diagnosis
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0011900
Descrição
Past
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C1444637
- UMLS CUI [1,2]
- C0011900
Descrição
Current
Tipo de dados
boolean
Alias
- UMLS CUI [1,1]
- C0521116
- UMLS CUI [1,2]
- C0011900
Similar models
Medical History and Physical Examination
- StudyEvent: ODM
C0031809 (UMLS CUI-2)
C0037088 (UMLS CUI [2])
C0011900 (UMLS CUI [1,2])
C0011900 (UMLS CUI [1,2])