post-marketing safety study of menactra® in healthy children, adolescents, and adults in the philippines

Conditions: Meningitis; Meningococcal Disease

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.

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

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 * 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.

Keywords: meningitis meningococcal disease menactra®