Clinical trial NCT00290329: Safety of Purified Meningococcal Vaccine With Serogroups ACWY, in 3,000 Filipino Subjects Aged > 2 Years
Official title: Multicentric, Surveillance Study to Monitor Safety of GSK Biologicals' Purified Meningococcal Polysaccharide Vaccine of Serogroups ACWY in 3,000 Filipino Subjects Aged Above 2 Years When Administered According to the Prescribing Information.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infections, Meningococcal
Keywords: Safety
Meningococcal disease
Meningitidis serogroups A, C,W & Y diseases
Meningococcal vaccine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 249
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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.

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 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.

Primary outcomes:
measure: Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events
timeFrame: During the 31-day (Days 0-30) post-vaccination period
Secondary outcomes:
measure: Number of Subjects With Any and Grade 3 Solicited Local Adverse Events
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
timeFrame: During the 4-day (Days 0-3) post-vaccination period
measure: Number of Subjects With Unsolicited Adverse Events (AEs)
timeFrame: During the 31-day (Days 0-30) post-vaccination period
measure: Number of Subjects With Serious Adverse Events (SAEs)
timeFrame: During the entire study period (from Day 0 to Month 1)
Other outcomes:
Locations:
city: Alabang, Muntinlupa City
country: Philippines
facility: GSK Investigational Site
city: Binangonan, Rizal
country: Philippines
facility: GSK Investigational Site
city: Cainta, Rizal
country: Philippines
facility: GSK Investigational Site
city: Las Pinas City
country: Philippines
facility: GSK Investigational Site
city: Los Banos, Laguna
country: Philippines
facility: GSK Investigational Site
city: Manila
country: Philippines
facility: GSK Investigational Site
city: Muntinlupa
country: Philippines
facility: GSK Investigational Site
city: Pasay City
country: Philippines
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: