NCT00290329

Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years

Multicentric, Surveillance Study to Monitor Safety of GSK Biologicals' Purified Meningococcal Polysaccharide Vaccine of Serogroups ACWY in 3,000 Filipino Subjects Aged Above 2 Years When Administered According to the Prescribing Information.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

GlaxoSmithKline Philippines has submitted a registration file for its Purified Meningococcal Polysaccharide of Serogroup ACWY Vaccine (Mencevax ACWY). This study is being conducted to collect clinical data in the local target population in order to assess the occurrence of rare adverse events after vaccination as per the requirement of Philippines Bureau of Food and Drugs Directive.

Detailed description

All subjects will receive a single dose of GSK Biologicals' Mencevax ACWY vaccine according to the prescribing information. Subjects will be stratified into the following age groups: 2 to 5 years 6 to 17 years \> 18 years The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Conditions

• Infections, Meningococcal

Interventions

Type	Name	Description
BIOLOGICAL	Mencevax ACWY	1 subcutaneous injection.

Timeline

• Start date: 2006-01-14
• Primary completion: 2006-10-01
• Completion: 2006-10-17
• First posted: 2006-02-13
• Last updated: 2018-06-08
• Results posted: 2017-03-14

Locations

8 sites across 1 country: Philippines