NCT01270503

Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines

Meningococcal (Groups A, C, Y, W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Post-Marketing Safety Study in Healthy Children (2-11 Years), Adolescents (12-17 Years) and Adults (18-55 Years) in the Philippines

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 538 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 2 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines. Primary Objective: To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.

Detailed description

Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.

Conditions

• Meningitis
• Meningococcal Disease

Interventions

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

Timeline

• Start date: 2010-12-01
• Primary completion: 2013-12-01
• Completion: 2014-07-01
• First posted: 2011-01-05
• Last updated: 2014-11-14
• Results posted: 2014-11-14

Locations

127 sites across 1 country: Philippines