ID
32451
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 defines when a subject should be excluded from the study or when a vaccination should be postponed. The form should be checked at each visit subsequent to the first visit.
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
Elimination Criteria
- StudyEvent: ODM
Descrizione
Elimination Criteria During the Study
Alias
- UMLS CUI-1
- C0680251
Descrizione
Use of investigational or non-registered product other than study vaccine
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0013230
- UMLS CUI [2,1]
- C0332300
- UMLS CUI [2,2]
- C1521826
- UMLS CUI [2,3]
- C0042210
Descrizione
Chronic administration of immunosuppressants except topic
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0021081
- UMLS CUI [1,2]
- C0205191
- UMLS CUI [2,1]
- C0332300
- UMLS CUI [2,2]
- C1522168
- UMLS CUI [2,3]
- C0038317
Descrizione
Administration of other vaccine
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0205394
Descrizione
Administration of immunoglobulins or blood products
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0371802
Descrizione
Contraindication to Subsequent Vaccination
Alias
- UMLS CUI-1
- C1301624
- UMLS CUI-2
- C0042196
Descrizione
Hypersensitivity to vaccine
Tipo di dati
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C1521826
- UMLS CUI [1,3]
- C0042210
Descrizione
Intussusception
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0021933
Descrizione
The following AEs constitute contraindications to administration of HRV vaccine or placebo at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE
Tipo di dati
float
Unità di misura
- °C
Alias
- UMLS CUI [1]
- C0489749
- UMLS CUI [2]
- C1531924
Descrizione
The following AEs constitute contraindications to administration of HRV vaccine or placebo at that point in time; if any one of these AEs occurs at the time scheduled for vaccination, the subject may be vaccinated at a later date, within the time window specified in the protocol, or withdrawn at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE
Tipo di dati
boolean
Alias
- UMLS CUI [1]
- C0017160
Similar models
Elimination Criteria
- StudyEvent: ODM
C0332300 (UMLS CUI [2,1])
C1521826 (UMLS CUI [2,2])
C0042210 (UMLS CUI [2,3])
C0205191 (UMLS CUI [1,2])
C0332300 (UMLS CUI [2,1])
C1522168 (UMLS CUI [2,2])
C0038317 (UMLS CUI [2,3])
C0205394 (UMLS CUI [1,2])
C0371802 (UMLS CUI [2])
C0042196 (UMLS CUI-2)
C1521826 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C1531924 (UMLS CUI [2])