![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00290329 |
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.
Condition | Intervention | Phase |
---|---|---|
Meningococcal Disease |
Biological: Mencevax ACWY |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
Official Title: | Multicentric, Surveillance Study to Monitor Safety of GSK Biologicals' Purified Meningococcal Polysaccharide Vaccine of Serogroups ACWY in 3,000 Filipino Subjects Aged > 2 Yrs When Administered According to the Prescribing Information. |
Enrollment: | 249 |
Study Start Date: | January 2006 |
Study Completion Date: | October 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Group A: Experimental |
Biological: Mencevax ACWY
1 subcutaneous injection.
|
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.
Ages Eligible for Study: | 2 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion criteria:
Philippines | |
GSK Investigational Site | |
Los Banos, Laguna, Philippines, 4027 | |
GSK Investigational Site | |
Pasay City, Philippines | |
GSK Investigational Site | |
Alabang, Muntinlupa City, Philippines | |
GSK Investigational Site | |
Cainta, Rizal, Philippines | |
GSK Investigational Site | |
Manila, Philippines, 1000 | |
GSK Investigational Site | |
Las Pinas City, Philippines | |
GSK Investigational Site | |
Muntinlupa, Philippines, 1781 | |
GSK Investigational Site | |
Binangonan, Rizal, Philippines |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 208144/002 |
Study First Received: | February 10, 2006 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00290329 |
Health Authority: | Philippines: Department of Health |
Meningitidis serogroups A, C,W & Y diseases Meningococcal vaccine Meningococcal disease Safety |
Bacterial Infections Meningococcal Infections Meningococcal infection Gram-Negative Bacterial Infections Neisseriaceae Infections |