N/A
Completed N=62,626
Descriptive, Post-marketing, Surveillance Safety Study of Menactra Vaccine
Source: ClinicalTrials.gov NCT00254995 ↗Enrolled (actual)
62,626
Serious AEs
0.9%
Results posted
Nov 2014
Primary outcomePrimary: Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance — 0.98; 0.52; 0.38; 0.03 Events per 1,000 person-months
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Diagnoses With Significantly Elevated Findings From Risk-Window vs. Control-Window Comparisons: All Ages Combined - Short-Term Passive Surveillance |
0.98; 0.52; 0.38; 0.03; 0.19; 0.00 | — |
Eligibility Criteria
Inclusion Criteria
- Receipt of Menactra vaccine during the study period.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00254995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.