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Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine
N/A
Waitlist Available
Research Sponsored by Sanofi Pasteur, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Receipt of Menactra vaccine during the study period.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 up to day 180 post-vaccination
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Meningitis
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 up to day 180 post-vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 up to day 180 post-vaccination
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance
Other study objectives
Rates of Serious Adverse Events Per 1000 Doses During 6 Months After Menactra Vaccination - ER Setting - All Ages Combined.
Rates of Serious Adverse Events Per 1000 Doses at During 6 Months After Menactra Vaccination - Hospital Setting - All Ages Combined
Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons - By Age Categories - Short-Term Passive Surveillance
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Menactra Vaccine RecipientsExperimental Treatment1 Intervention
Participants who received Menactra vaccine as part of routine medical care during the study period in Kaiser Permanente.
Group II: Age-Matched ControlExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
None administered in this study
2005
N/A
~64050
Find a Location
Who is running the clinical trial?
Sanofi Pasteur, a Sanofi CompanyLead Sponsor
422 Previous Clinical Trials
6,050,476 Total Patients Enrolled
44 Trials studying Meningitis
28,135 Patients Enrolled for Meningitis
Medical DirectorStudy DirectorSanofi Pasteur Inc.
2,905 Previous Clinical Trials
8,028,863 Total Patients Enrolled
35 Trials studying Meningitis
23,485 Patients Enrolled for Meningitis