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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Meningitis, Meningococcal Infection
Interventions: Meningococcal Diphtheria Toxoid Vaccine
Countries: India, Russia
The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers. Primary Objectives: * To assess the seroprotection rate (percentage of subjects with a serum bactericidal assay using human complement \[SBA-HC\] titer ≥ 1:8) 28 days after the second of 2 doses of Menactra® administered 3 to 6 months apart. Secondary Objectives: * To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers. * To assess the safety profile of Menactra® after each and any vaccination.
Sex: ALL
Age: 9 Months to 17 Months
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: * Male and female subjects aged 9 to 17 months on the day of inclusion * Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable) * Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: * Participation in the 4 weeks preceding inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure. * Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for: * (i) influenza vaccination, which may be received at least 2 weeks before study vaccines. * (ii) measles (M) or measles, mumps, rubella (MMR) routine vaccination, which can be administered concomitantly with the first dose of study vaccine as per routine immunization schedule * (iii) for subjects enrolled at Indian sites: oral poliomyelitis vaccine (OPV) received during National Immunization Days (NIDs) and supplementary immunization activity days (SIADs) * Previous vaccination against meningococcal disease with either the study vaccine or another meningococcal vaccine * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) * History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically * At high risk, in the opinion of the Investigator, for meningococcal disease during the trial * Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances * Known thrombocytopenia, contraindicating intramuscular vaccination * Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination * In an emergency setting, or hospitalized involuntarily * Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion * For subjects enrolled at Indian sites: Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). * For subjects enrolled at Russian sites: Acute disease of any severity on the day of vaccination or febrile illness (axillary temperature ≥ 37.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided. * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw * Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study * Personal history of Guillain-Barré Syndrome.
- Vadodara, Gujarat, India
- Kolkata, West Bengal, India
- Lucknow, India
- Vellore, India
- Murmansk, Russia
- Perm, Russia
- Saint Petersburg, Russia
- Yekaterinburg, Russia