ID
32451
Beschrijving
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.
Link
https://clinicaltrials.gov/ct2/show/NCT00241644
Trefwoorden
Versies (1)
- 01-11-18 01-11-18 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
1 november 2018
DOI
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Licentie
Creative Commons BY-NC 3.0
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Efficacy, Safety and Immunogenicity of Oral HRV Vaccine NCT00241644
Elimination Criteria
- StudyEvent: ODM
Beschrijving
Elimination Criteria During the Study
Alias
- UMLS CUI-1
- C0680251
Beschrijving
Use of investigational or non-registered product other than study vaccine
Datatype
boolean
Alias
- UMLS CUI [1]
- C0013230
- UMLS CUI [2,1]
- C0332300
- UMLS CUI [2,2]
- C1521826
- UMLS CUI [2,3]
- C0042210
Beschrijving
Chronic administration of immunosuppressants except topic
Datatype
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
Beschrijving
Administration of other vaccine
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C2368628
- UMLS CUI [1,2]
- C0205394
Beschrijving
Administration of immunoglobulins or blood products
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021027
- UMLS CUI [2]
- C0371802
Beschrijving
Contraindication to Subsequent Vaccination
Alias
- UMLS CUI-1
- C1301624
- UMLS CUI-2
- C0042196
Beschrijving
Hypersensitivity to vaccine
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0020517
- UMLS CUI [1,2]
- C1521826
- UMLS CUI [1,3]
- C0042210
Beschrijving
Intussusception
Datatype
boolean
Alias
- UMLS CUI [1]
- C0021933
Beschrijving
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
Datatype
float
Maateenheden
- °C
Alias
- UMLS CUI [1]
- C0489749
- UMLS CUI [2]
- C1531924
Beschrijving
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
Datatype
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])