Status:
COMPLETED
Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years
Lead Sponsor:
GlaxoSmithKline
Conditions:
Infections, Meningococcal
Eligibility:
All Genders
2+ years
Phase:
PHASE4
Brief 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...
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 t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 14 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2006
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT00290329
Start Date
January 14 2006
End Date
October 17 2006
Last Update
June 8 2018
Active Locations (8)
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1
GSK Investigational Site
Alabang, Muntinlupa City, Philippines, 1780
2
GSK Investigational Site
Binangonan, Rizal, Philippines
3
GSK Investigational Site
Cainta, Rizal, Philippines
4
GSK Investigational Site
City of Muntinlupa, Philippines, 1781