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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Infections, Meningococcal

Treatments

Biological: Mencevax ACWY

Study type

Interventional

Funder types

Industry

Identifiers

NCT00290329

208144/002

Details and patient eligibility

About

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.

Full 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.

Enrollment

249 patients

Sex

All

Ages

2+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects who the investigator believes that they and/or their parent/guardian can and will comply with the requirements of the protocol.
A Filipino male or female > 2 years of age at the time of the first vaccination.
Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Written informed consent obtained from the subject and/or from the parent/ guardian of the subject.

Exclusion criteria

Subjects suffering from acute severe febrile illness.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Pregnant or lactating female.
Female planning to become pregnant.
History of chronic alcohol consumption and/or intravenous drug abuse.
Any contraindications as stated on the Prescribing Information.