Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children

Meningitis Clinical Trial

Official title:

Post-licensure Safety Surveillance Study of Menactra® Vaccine When Administered As a 2-dose Schedule to Children 9 Months Through 23 Months of Age.

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

Related Conditions & MeSH terms

• Meningitis
• Meningococcal Infection
• Meningococcal Infections

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

External Links

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