Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines

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

Official Title
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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

Conditions
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Meningitis, Meningococcal Disease

Intervention / Treatment
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* Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
* Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
* Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate


Participation Criteria
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Eligibility Criteria
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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 History of seizures Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection Personal of family history of Guillain-Barré Syndrome.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Menactra® Group 1<br>Participants aged 2 to 11 on enrollment | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|
| Experimental: Menactra® Group 2<br>Participants aged 12 to 17 on enrollment | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|
| Experimental: Menactra® Group 3<br>Participants aged 18 to 55 on enrollment | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Overview Within 30 Days in Participants Vaccinated With Menactra® |  | Day 0 up to Day 30 post-vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningitis, Meningococcal disease, Menactra®