NCT01689155

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 116 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 9 Months – 23 Months
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Meningitis
• Meningococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate	0.5 mL, Intramuscular

Timeline

• Start date: 2011-06-01
• Primary completion: 2015-06-01
• Completion: 2016-04-01
• First posted: 2012-09-21
• Last updated: 2016-11-11
• Results posted: 2016-11-11

Locations

1 site across 1 country: United States