Meningococcal (Groups A, C, Y, W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Post-Marketing Safety Study in Healthy Children (2-11 Years), Adolescents (12-17 Years) and Adults (18-55 Years) in the Philippines

Sanofi Pasteur, a Sanofi Company0 sites538 target enrollmentDecember 2010

ConditionsMeningitis Meningococcal Disease

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Meningitis
Sponsor: Sanofi Pasteur, a Sanofi Company
Enrollment: 538
Primary Endpoint: Safety Overview Within 30 Days in Participants Vaccinated With Menactra®
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines.

Primary Objective:

To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.

Detailed Description

Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

July 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi Pasteur, a Sanofi Company

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 2 to 11 years of age on the day of inclusion (Group 1)
•Aged 12 to 17 years of age on the day of inclusion (Group 2)
•Aged 18 to 55 years of age on the day of inclusion (Group 3)
•Provision of informed consent form signed by the parent(s) or legal representative (Group 1)
•Provision of assent form signed by the subject and informed consent form signed by the parent (s) or legal representative (Group 2)
•Provision of informed consent form signed by the subject (Group 3)
•If the subject (Group 3) or the subject's parents or legally accepted representative (Group 1 and 2) are illiterate, an independent witness is required to sign the consent form
•Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures
•For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for females not of child-bearing potential or not sexually active).

Exclusion Criteria

•For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for females not of child-bearing potential or not sexually active)
•Breast-feeding woman
•Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
•Planned participation in another clinical trial during the present trial period
•Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
•Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
•Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
•Receipt of any vaccine in the 4 weeks preceding the trial vaccination
•Planned receipt of any vaccine during the present trial period
•Known personal or maternal Human Immunodeficiency virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity as reported by the subject/parent/guardian and/or based on medical history

Outcomes

Primary Outcomes

Safety Overview Within 30 Days in Participants Vaccinated With Menactra®

Time Frame: Day 0 up to Day 30 post-vaccination

Secondary Outcomes

Number of Subjects Reporting Non-serious Related Adverse Events Not Listed in Prescribing Information (PI) Following Vaccination With Menactra®(Day 0 up to Day 30 post-vaccination)