Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine

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

62626 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2013-05-31

Brief Summary

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To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.

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Detailed Description

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Conditions

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Meningitis Meningococcal Disease

Study Design

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Observational Model Type

COHORT

Study Groups

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Menactra Vaccine Recipients

Participants who received Menactra vaccine as part of routine medical care during the study period in Kaiser Permanente.

None administered in this study

Intervention Type BIOLOGICAL

N/A in this study

Age-Matched Control

Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0-30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine as part of routine medical care during the same month 1 year earlier in Kaiser Permanente