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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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (8 locations)

    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