N/A
Completed N=116
Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children
Meningitis · Meningococcal Infection
Source: ClinicalTrials.gov NCT01689155 ↗
Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcomePrimary: Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. — 0.009; 0.006; 0.009; 0.006 Events per 1,000 person-months
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rates of Safety Outcomes at Days 0-30 vs Days 31-75 After Menactra Vaccine - Emergency Room Database. |
0.009; 0.006; 0.009; 0.006; 0.009; 0.000 | — |
Eligibility Criteria
Inclusion Criteria
- Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine during the study period.
Data sourced from ClinicalTrials.gov (NCT01689155). 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.