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Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children

NCT ID: NCT01689155

Last Updated: 2016-11-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2016-04-30

Brief Summary

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This is a passive-surveillance study that will accrue subjects for surveillance. For each accrued subject, surveillance for outcomes will continue for six months following the first dose. If a second dose is given within that time, then surveillance will be continued for six months following the second dose.

Observational Objective:

* To describe and characterize adverse events occurring after vaccination with Menactra vaccine.

Detailed Description

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The study will be carried out in collaboration with the Kaiser Permanente Medical Care Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC). KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter databases that capture all medical care received by enrollees.

Vaccination will be according to routine clinical practice. Vaccination databases will be reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.

Conditions

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Meningitis Meningococcal Infection

Keywords

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Meningitis Meningococcal Infection Menactra®

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Group

Participants must have received Menactra Vaccine according to routine clinical practice.

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Intervention Type BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

0.5 mL, Intramuscular

Intervention Type BIOLOGICAL

Other Intervention Names

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Menactra®

Eligibility Criteria

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Inclusion Criteria

* Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine during the study period.
Minimum Eligible Age

9 Months

Maximum Eligible Age

23 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

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Oakland, California, United States

Site Status

Countries

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United States

References

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Hansen J, Zhang L, Eaton A, Baxter R, Robertson CA, Decker MD, Greenberg DP, Bassily E, Klein NP. Post-licensure safety surveillance study of routine use of quadrivalent meningococcal diphtheria toxoid conjugate vaccine (MenACWY-D) in infants and children. Vaccine. 2018 Apr 12;36(16):2133-2138. doi: 10.1016/j.vaccine.2018.02.107. Epub 2018 Mar 14.

Reference Type DERIVED
PMID: 29550195 (View on PubMed)

Related Links

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http://www.sanofipasteur.com

Related Info

Other Identifiers

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U 1111-1120-1574

Identifier Type: OTHER

Identifier Source: secondary_id

MTA57

Identifier Type: -

Identifier Source: org_study_id