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