結果顯示，接受新疫苗的青少年對這四種血清型的效果都相當於或優於美國其他核准的腦膜炎球菌共價疫苗 (商品名Menactra，Sanofi-Pasteur藥廠；血清型A為75% vs 67%；血清型C兩者皆為84%；血清型Y為88% vs 69%；血清型W-135為96% vs 88%)。接種疫苗的幾何平均效價達到此一趨勢(血清型A為29 vs 18；血清型C為59 vs 47；血清型Y為51 vs 18；血清型W-135為87 vs 44)。
February 23, 2010 — The US Food and Drug Administration (FDA) has approved a quadrivalent meningococcal vaccine (Menveo, Novartis Pharmaceuticals, Inc) for the prevention of invasive disease caused by common Neisseria meningitides serogroups A, C, Y, and W-135 in people aged 11 to 55 years.
Meningococcal disease is a leading cause of bacterial meningitis, which can progress rapidly despite early and appropriate treatment, potentially resulting in death within 24 to 48 hours of symptom onset. About 1 in 7 patients who survive the disease experience serious permanent effects, including amputations, seizures, paralysis, hearing loss, and learning disabilities.
Vaccination may be a key factor for avoiding infection in susceptible adolescents, the company noted in a news release. Since 2005, the Advisory Committee on Immunization Practices has recommended routine immunization with a quadrivalent meningococcal conjugate vaccine for all adolescents aged 11 to 18 years, as well as older high-risk groups, such as college freshmen living in dormitories.
"The FDA approval of Menveo is an important milestone for adolescent immunization in the United States. According to CDC estimates, approximately 16 million adolescents between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease," said Andrin Oswald, MD, division head of Novartis Vaccines and Diagnostics. "Meningococcal disease is particularly distressing because it can rapidly kill or debilitate previously healthy adolescents."
Approval was based on data from a phase 3 trial that was broken in to 2 subsets: adolescents aged 11 to 18 years and adults aged 19 to 55 years.
Results showed that adolescents receiving the new vaccine demonstrated comparable or greater immune responses to each of the 4 serogroups compared with another US-licensed meningococcal conjugate vaccine (Menactra, Sanofi-Pasteur; serogroup A, 75% vs 67%; serogroup C, 84% for both; serogroup Y, 88% vs 69%; serogroup W-135, 96% vs 88%). Geometric mean titres achieved with vaccination followed this trend (serogroup A, 29 vs 18; serogroup C, 59 vs 47; serogroup Y, 51 vs 18; serogroup W-135, 87 vs 44).
Although the seroresponse was statistically higher for serogroups A, Y, and W-135, the clinical relevance of this finding remains unclear, company officials noted.
Use of the vaccine is contraindicated in patients with hypersensitivity to prior doses of the vaccine, any of its components, or other CRM197, diphtheria toxoid, or meningococcal-based vaccine. Vaccination may not protect all individuals, such as those who are immunocompromised or receiving immunosuppressive therapy.
Adverse events most commonly reported in trial experience include anaphylactic reactions, syncope, injection-site pain, headache, myalgia, malaise, and nausea. Patients should be observed for 15 minutes following vaccine administration.
According to the news release, the company plans to seek supplementary licensures for vaccine use in other age groups, including an indication for children aged 2 to 10 years.
