N/A
Completed N=1,421
36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds
Source: ClinicalTrials.gov NCT00728260 ↗Enrolled (actual)
1,421
Serious AEs
1.1%
Results posted
Feb 2015
Primary outcomePrimary: Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level. — 1.4; 2.3 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 Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level. |
0.0; 0.0 | — |
| PRIMARY Summary of Diagnoses With Elevated Findings for Risk-Window vs. Control-Window Comparisons at the 5% Significance Level. |
0.0; 0.0 | — |
Eligibility Criteria
Inclusion Criteria
- Receipt of Menactra vaccine during the study period.
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00728260). 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.