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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00290329

Purpose

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

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

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.

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Occurrence of Grade 3 unsolicited adverse events. [ Time Frame: During the 31-day follow-up period after vaccination. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of solicited local and general adverse events. [ Time Frame: During the 4-day follow up after vaccination. ] [ Designated as safety issue: Yes ]
Occurrence of unsolicited adverse events. [ Time Frame: During the 31-day follow-up period after vaccination. ] [ Designated as safety issue: Yes ]
Occurrence of serious adverse events. [ Time Frame: During the entire study period. ] [ Designated as safety issue: Yes ]

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.

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 to 17 years > 18 years The Protocol Posting has been updated in order to comply with the FDA Amendment Act, September 2007.

Eligibility

Ages Eligible for Study:	2 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290329

Locations

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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

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

Keywords provided by GlaxoSmithKline:

Meningitidis serogroups A, C,W & Y diseases
Meningococcal vaccine
Meningococcal disease
Safety

Study placed in the following topic categories:

Bacterial Infections
Meningococcal Infections
Meningococcal infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on January 16, 2009