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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01689155
Other study ID # MTA57
Secondary ID U 1111-1120-1574
Status Enrolling by invitation
Phase N/A
First received September 14, 2012
Last updated July 14, 2015
Start date August 2012
Est. completion date April 2016

Study information

Verified date July 2015
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


Description:

The study will be carried out in collaboration with the Kaiser Permanente Medical Care Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC). KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter databases that capture all medical care received by enrollees.

Vaccination will be according to routine clinical practice. Vaccination databases will be reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 122
Est. completion date April 2016
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 9 Months to 23 Months
Eligibility Inclusion Criteria:

- Age 9 to 23 months at the time of receipt of the first dose of Menactra vaccine during the study period.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Biological:
Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of adverse events (AEs) and serious adverse events (SAEs) reported in the database following Menactra vaccination. Surveillance will include all emergency room visits, hospitalizations and related databases will be reviewed to identify all medical care events for vaccinees. Up to 6 months post-vaccination No
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