Observational Safety Study of Menactra® Administered Under Standard Health Care Practice in the Russian Federation
NCT ID: NCT02699840
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2016-02-29
2016-07-25
Brief Summary
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Primary Objective:
* To describe the safety profile after 1 dose of Menactra® administered in individuals 2-55 years of age under standard health care practices.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Menactra Study Group 1
Participant aged 2 through 11 years at vaccination
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be provided as part of this study
Menactra Study Group 2
Participant aged 12 through 17 years at vaccination
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be provided as part of this study
Menactra Study Group 3
Participant aged 18 through 55 years at vaccination
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be provided as part of this study
Interventions
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Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be provided as part of this study
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be provided as part of this study
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
No vaccine will be provided as part of this study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* For adults (18-55 years old) Informed consent form has been signed and dated by the participant.
* For minors: Informed consent form has been signed and dated by the parent. In addition, in accordance with the Institution Ethics Committee/Institution Review Board requirements and as appropriate for the age of the participant:
* participants aged 14 to 17 years are required to sign and date the informed consent form,
* participants aged 10 to 13 years are required to sign and date the assent form,
* for participants under 10 years, consent may be asked orally according to participant's age and ability for understanding
* Receipt of one dose of Menactra® on the day of inclusion and prior to enrollment into the study, in routine practice according to the approved local product insert.
Exclusion Criteria
2 Years
55 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Russia
Locations
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Moscow, , Russia
Countries
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Related Links
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Related Info
Other Identifiers
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U1111-1174-4339
Identifier Type: OTHER
Identifier Source: secondary_id
MTA92
Identifier Type: -
Identifier Source: org_study_id
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