a study of meningococcal vaccine, menactra® in healthy subjects in india

Conditions: Meningococcal Infection; Meningitis

Summary: the purpose of this study is to assess the safety and immunogenicity of a single dose of menactra® vaccine to support registration. primary objectives: * to describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (sba-br) before and after menactra® vaccination. * to describe the safety profile of participants after one dose of menactra®.

participants will be enrolled in three age cohorts: children: 2 - 11 years of age; adolescents: 12 - 17 years of age, and adults: 18 - 55 years of age to receive a single dose of menactra®. they will be followed for a duration of 30 days after vaccination.

Eligibility criteria:
inclusion criteria : * aged 2 to 11 years or aged 12 to 17 years or aged 18 to 55 years of age on the day of inclusion * for participants aged 2 to 11 years: provision of informed consent form signed by the parent(s) or legal representative. * for participants aged 12 to 17 years: provision of assent form signed by the participant and informed consent form signed by the parent(s) or legal representative. * for participants aged 18 to 55 years: provision of informed consent form signed by the participant. if the participant or the participant's parents or legally accepted representative (participants aged 2 to 17 years) are illiterate, an independent witness is required to sign the consent form. * participant 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 participants aged 2 to 17 years' 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 participants aged 2 to 17 years' 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 corticosteroids 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 * current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures * receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response * receipt or planned receipt of any vaccine (other than influenza vaccine which can be given 2 weeks or more before vaccination) in the 4 weeks preceding or following the trial vaccination * known human immunodeficiency virus (hiv), hepatitis b surface (hbs) antigen , or hepatitis c seropositivity as reported by the participant/parent/guardian and/or based on medical history * history of documented invasive meningococcal disease * previous vaccination against meningococcal disease with either the trial vaccine or another vaccine * thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination * subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent * personal or family history of guillain-barré syndrome temporary contraindications delaying vaccination until resolved: * febrile illness (temperature ≥38.0°c) or moderate or severe acute illness/infection on the day of vaccination * received oral or injected antibiotic therapy within the 72 hours prior to any blood draw

Keywords: meningococcal infection meningitis, bacterial menactra®