Date: 2012-02-07
Type of information:
phase:
Announcement: publication of study results in the February 8, 2012 issue The Journal of the American Medical Association (JAMA)
The title of the article is \"Immunogenicity and tolerability of recombinant meningococcal serogroup B vaccine administered with or without routine infant vaccinations according to different immunization schedules: A randomized controlled trial\" by Nicoletta Gossger MD, Matthew D Snape FRCPCH MD, et al.
Company: Novartis (Switzerland)
Product: Bexsero®
Action mechanism:
Disease: meningococcal B diseases
Therapeutic area: Infectious diseases
Country:
Trial
details: This pivotal Phase IIb open-label immunogenicity study randomized 1,885 infants to receive Bexsero® at 2, 4, 6 months together with routine infant vaccines; at 2, 4, 6 months with routine vaccines given separately at 3, 5, 7 months; or at 2, 3, 4 months together with routine infant vaccines. A control group received the routine vaccines only at 2, 3, 4 months. The routine vaccines used were 7-valent pneumococcal glycoconjugate vaccine and a combined diphtheria, tetanus, acellular pertussis, inactivated polio, hepatitis B and Haemophilus influenzae type b vaccine.
Immune response was measured using the human serum bactericidal antibody (hSBA) assay with a titer >= 1:5, which is the accepted level that correlates with protection.
Latest
news: Novartis has announced that The Journal of the American Medical Association (JAMA) published a study that shows Bexsero® induced a robust immune response against meningococcal B disease in the vast majority of infants vaccinated. These results also show that Bexsero can fit into various vaccination schedules in the first year of life when the likelihood of contracting this often-deadly disease is greatest. The study also demonstrated that Bexsero® has an acceptable tolerability profile.
These data were first presented in 2011 at the 29th Annual Meeting of the European Society of Paediatric Infectious Diseases (ESPID).
The study met all of its primary endpoints, and showed that the majority of infants vaccinated with Bexsero®, at either dosing schedule with or without routine vaccines, achieved hSBA >= 1:5 against all vaccine antigens in tested MenB strains (H44/76, 5/99, NZ98/254). More than 99% of participants receiving Bexsero® at 2, 4, 6 months (with or without routine vaccines) or at 2, 3 and 4 months (with routine vaccines) developed hSBA titers >= 1:5 against the reference strains 44/76 and 5/99. For NZ98/254 the >= 1:5 result was reached or exceeded in 79% (2, 4, 6 months with routine vaccines), 87% (2, 4, 6 months without routine vaccines) and 81% (2, 3, 4 months with routine vaccines) of patients on the corresponding schedules.
The immune response to routine vaccine antigens when co-administered with Bexsero® was similar to that in the control group[1], except for slightly lower immune responses to pneumococcal serotype 6B and pertactin, comparable with other licensed vaccines.
The data also showed that Bexsero®, when administered alone, had a reactogenicity profile that was comparable to those of the routine vaccines. Fever, which is a common event following routine childhood immunizations, was observed more frequently in infants who received Bexsero® together with routine infant vaccines compared to infants receiving routine vaccines alone. Fever was generally mild-to-moderate and of short duration, with more than 95% of cases resolving within 24-48 hours.
In December 2010, a Marketing Authorization Application (MAA) for Bexsero® was submitted in Europe and in other countries, including a proposed infant vaccination schedule consisting of three doses for the primary series. Regulatory action is expected later in 2012.
