study of menactra® in healthy subjects at 9 months and concomitantly with pentacel® at 15 to 18 months of age

Conditions: Meningitis; Meningococcal Infection; Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Serotype b (Hib)

Summary: the aim of the study is to further characterize the safety and immunogenicity of menactra® in the population \<2 years of age when administered alone and when the second dose is administered concomitantly with the 4th dose of pentacel®, a licensed pediatric vaccine. primary objectives: * to evaluate and compare the antibody responses to meningococcal serogroups a, c, y, and w-135 induced by 2 injections of menactra® in subjects aged 9 months at the first vaccination visit and 15 to 18 months at the second vaccination visit. * to evaluate and compare the antibody responses to pertussis (pertussis toxoid \[pt\], filamentous haemagglutinin \[fha\] and pertactin \[prn\]) antigens induced by a dose of pentacel® when administered concomitantly with menactra® to those elicited by a dose of pentacel® administered alone. * to evaluate and compare the antibody responses to polyribosylribitol phosphate (prp), tetanus and diphtheria antigens induced by a dose of pentacel® when administered concomitantly with menactra® to those elicited by a dose of pentacel® alone. observational objectives: * to describe the safety profile (immediate unsolicited aes within 30 minutes of each trial vaccination, solicited reactions within 7 days of each vaccination, unsolicited aes within 30 days of each vaccination, and serious adverse events \[saes\] throughout the course of the trial from day 0 up to day 30 after the last trial vaccination\[s\]) in all trial groups * to describe the antibody responses to meningococcal serogroups a, c, y, and w-135, measured by sba hc, 30 days after the second menactra® administration * to describe the antibody responses to pentacel® (pt, fha, prn, fim, diphtheria, tetanus, polio, prp) measured by enzyme-linked immunosorbent assay (elisa), radioimmunoassay (ria), or functional assays.

participants will be vaccinated according to their randomized groups at age 9 months and at age 15 to 18 months. they will undergo immunogenicity assessment and safety monitoring post-vaccination.

Eligibility criteria:
inclusion criteria: * aged 9 months (249 to 305 days) for groups 1 and 2, or 15 to 18 months (420 to 570 days) for group 3 on the day of the first trial visit * informed consent form has been signed and dated by the parent(s) or other legally acceptable representative * received 3 doses of any dtap-containing vaccines * received 3 doses of a hib-containing vaccine, or 2 doses if the subject received prp-omp (pedvaxhib® or comvax®\[hepb-hib\]) * received at least 3 doses of a crm197-based pneumococcal conjugate vaccine (pneumococcal conjugate vaccine \[pcv\] or 13-valent pneumococcal conjugate vaccine \[pcv13\]) * subject and parent/ legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria: * participation in the 4 weeks preceding the first trial vaccination 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 influenza vaccination, which may be received at least 2 weeks before or after the trial vaccination(s) * vaccination against meningococcal disease with either the trial vaccine or another vaccine, or receipt of the 4th dose of any dtap-containing vaccines, receipt of the 4th dose of a hib-containing vaccine, or receipt of the 3rd dose of prp-omp (pedvaxhib® or comvax® \[hep b-hib\]) prior to enrollment or during the conduction of the trial, except for group 1 subjects, who may receive hib vaccine at 12 months * 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). topical steroids are not included in this exclusion criterion * history of invasive meningococcal infection, confirmed either clinically, serologically, or microbiologically * personal history of guillain-barré syndrome * history of encephalopathy (e.g., coma, decreased level of consciousness, prolonged seizures) within 7 days of a previous dose of a pertussis containing vaccine that is not attributable to another identifiable cause * known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to one of the vaccines used in the trial or to a vaccine containing any of the same substances * known thrombocytopenia, as reported by the parent/ legally acceptable representative, 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 * moderate or severe acute illness/ infection (according to investigator judgment) or febrile illness (temperature ≥ 100.4°f \[≥ 38.0°c\]) on the day of vaccination. a prospective subject should not be included in the trial until the condition has resolved or the febrile event has subsided * receipt of oral or injectable antibiotic therapy within 72 hours prior to any trial blood draw (topical antibiotics, drops, or ointments are not included in this criterion) * identified as a natural or adopted child of the investigator or employee with direct involvement in the proposed trial.

Keywords: meningitis meningococcal infection diphtheria pertussis menactra® pentacel®