ID

32983

Description

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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Versions (1)
  1. 11/22/18 11/22/18 -
Copyright Holder

GSK group of companies

Uploaded on

November 22, 2018

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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 forms  
Note
Description

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.
Description

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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text

Contraindications to Subsequent Vaccination
Description

Contraindications to Subsequent Vaccination

Check event(s) that occurred
Description

Check event(s) that occurred

Data type

integer

Precautions for Vaccination
Description

Precautions for Vaccination

Read the list
Description

Read the list

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text

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Contraindications to Subsequent Vaccination

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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.
text
Item Group
Contraindications to Subsequent Vaccination
Item
Check event(s) that occurred
integer
Check event(s) that occurred
Code List
Check event(s) that occurred
CL Item
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)
CL Item
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)
CL Item
Acute disease at the time of vaccination. (5)
CL Item
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
Read the list
CL Item
It is recommended that members of the investigational team must be immune to the vaccine components under investigation. (1)
CL Item
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)
CL Item
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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