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

NCT00290329 | Completed Phase 4 Results

• 1 other identifier: 208144/002
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 8

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.

Conditions

Infections, Meningococcal

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Severe (Grade 3) Unsolicited Adverse Events

  An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Grade 3 AE = an AE which prevented normal, everyday activities.

  During the 31-day (Days 0-30) post-vaccination period

Secondary Outcomes (5)

• Number of Subjects With Any and Grade 3 Solicited Local Adverse Events

  During the 4-day (Days 0-3) post-vaccination period

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  During the 4-day (Days 0-3) post-vaccination period

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  During the 4-day (Days 0-3) post-vaccination period

• Number of Subjects With Unsolicited Adverse Events (AEs)

  During the 31-day (Days 0-30) post-vaccination period

• Number of Subjects With Serious Adverse Events (SAEs)

  During the entire study period (from Day 0 to Month 1)

Study Arms (1)

Group A

EXPERIMENTAL

Biological: Mencevax ACWY

Interventions

Mencevax ACWY BIOLOGICAL

1 subcutaneous injection.

Also known as: Neisseria meningitidis serogroups A, C, W and Y vaccine

Group A

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Alabang, Muntinlupa City, 1780, Philippines

Location

GSK Investigational Site

Binangonan, Rizal, Philippines

Location

GSK Investigational Site

Cainta, Rizal, Philippines

Location

GSK Investigational Site

City of Muntinlupa, 1781, Philippines

Location

GSK Investigational Site

Las Piñas, Philippines

Location

GSK Investigational Site

Los Banos, Laguna, 4027, Philippines

Location

GSK Investigational Site

Manila, 1000, Philippines

Location

GSK Investigational Site

Pasay, Philippines

Location

MeSH Terms

Conditions

Meningococcal Infections

Interventions

PsACWY vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2006
• First Posted: February 13, 2006
• Study Start: January 14, 2006
• Primary Completion: October 1, 2006
• Study Completion: October 17, 2006
• Last Updated: June 8, 2018
• Results First Posted: March 14, 2017

Record last verified: 2017-01

Locations

PH (8)