ID

32983

Descrizione

Study ID: 104020 Clinical Study ID: 104020 Study Title: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00126997 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 4 Study Recruitment Status: Completed Generic Name: Combined Measles, Mumps, Rubella, Varicella Vaccine Trade Name: Priorix Tetra Study Indication: Measles; Mumps; Rubella; Varicella

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versioni (1)
  1. 22/11/18 22/11/18 -
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GSK group of companies

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22 novembre 2018

DOI

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Creative Commons BY-NC 3.0
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Immunogenicity of Combined Measles, Mumps, Rubella, Varicella Vaccine for healthy 2 y.o children - 104020

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Contraindications to Subsequent Vaccination

1 moduli  
Note
Descrizione

Note

The following Adverse Events constitute absolute contradictions to further administration of MeMuRu-OKA vaccine; If any of these AEs occur during the study, the subject must NOT receive additional doses of vaccine but may continue other study procedures at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE.
Descrizione

The following Adverse Events constitute absolute contradictions to further administration of MeMuRu-OKA vaccine; If any of these AEs occur during the study, the subject must NOT receive additional doses of vaccine but may continue other study procedures at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE.

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Contraindications to Subsequent Vaccination
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Contraindications to Subsequent Vaccination

Check event(s) that occurred
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Check event(s) that occurred

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Precautions for Vaccination
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Precautions for Vaccination

Read the list
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Read the list

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Contraindications to Subsequent Vaccination

1 moduli
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Description | Question | Decode (Coded Value)
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Item Group
Note
The following Adverse Events constitute absolute contradictions to further administration of MeMuRu-OKA vaccine; If any of these AEs occur during the study, the subject must NOT receive additional doses of vaccine but may continue other study procedures at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE.
Item
The following Adverse Events constitute absolute contradictions to further administration of MeMuRu-OKA vaccine; If any of these AEs occur during the study, the subject must NOT receive additional doses of vaccine but may continue other study procedures at the discretion of the investigator. The subject must be followed until resolution of the event, as with any AE.
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Item Group
Contraindications to Subsequent Vaccination
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Check event(s) that occurred
integer
Check event(s) that occurred
Code List
Check event(s) that occurred
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Subject diagnosed with immunosuppressive condition (i.e total lymphocyte count less than 1200 per mm3) or presenting other clinical or paraclinical evidence of lack of cellular immune competence. (1)
CL Item
Subjects with known systemic hypersensitivity or allergy to neomycin or other components of the vaccine. (2)
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Subjects who contract measles, mumps, rubella and/or varicella disease between the first and second vaccination should not receive the second dose. (3)
CL Item
Any anaphylactic reaction from previous dose of the study vaccine(s). (4)
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Acute disease at the time of vaccination. (5)
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Axillary temperature >= 37.5°C / rectal temperature >= 38°C (6)
Item Group
Precautions for Vaccination
Item
Read the list
text
Read the list
Code List
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CL Item
It is recommended that members of the investigational team must be immune to the vaccine components under investigation. (1)
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The use of salicylates by vaccine recipients (six weeks after each vaccination) should be avoided as Reye's Syndrome has been reported following the use of salicylates during varicella infection. (2)
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Residence in the household with a susceptible high-risk person are considered as exclusion criteria. (high-risk persons: newborns between 0-4 weeks old, pregnant women with negative history of chickenpox and without recorded vaccination against chickenpox, immunocompromised persons including those with HIV) (3)
CL Item
Measles and mumps vaccine strains are produced on chicken embryo fibroblast. Vaccines produced in chick embryo tissue cultures have been shown not to contain egg proteins in sufficient amounts to elicit hypersensitivity reactions; however, subject with a history of anaphylactic egg allergies should not receive these vaccines. (4)
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