The FINANCIAL — New Phase III data indicate that Menveo (Meningococcal Group A, C, W135 and Y conjugate vaccine) demonstrated robust immunogenicity in infants potentially offering protection against four major serogroups of meningococcal disease[1],[3].
These data were presented during an oral presentation at the 48th annual meeting of the Infectious Disease Society of America (IDSA) held in Vancouver, Canada.
This pivotal trial, including more than 4,500 infants worldwide, met its primary endpoints. Results show that a high percentage of infants vaccinated with four doses achieved robust immune responses against meningococcal serogroups A, C, W135 and Y[1]. Menveo was generally well tolerated when given either alone or co-administered with other pediatric vaccines[1]. Menveo has the potential to be the first meningococcal quadrivalent conjugate vaccine that induces high levels of protective antibodies against serogroups A, C, W135 and Y in infants vaccinated from 2 months of age. Infants under one year of age are at greatest risk for meningococcal disease and currently no broad-coverage vaccine is licensed for this population[2],[3].
"In my practice I have seen the devastating effects of meningococcal disease in infants," said Stan Block, MD, FAAP, an investigator for the study. "Meningococcal vaccines are being developed that can provide broad protection against the disease in this vulnerable population[2]."
Menveo has the potential to fulfill an unmet medical need as a vaccine that can help protect people, from early infancy to adulthood, against four major causes of meningococcal disease (serogroups A, C, W135 and Y) [4],[5], a sudden, unpredictable and often life-threatening illness[2],[2]. Together these four serogroups cause the majority of meningococcal disease cases in the United States (US), Africa, and the Middle East and are also present in Europe, Asia and Latin America[6],[7].
"As the most vulnerable age group, infants should be directly protected from this unpredictable and devastating disease," said Andrin Oswald, Division Head of Novartis Vaccines and Diagnostics. "These data are another step in the significant progress Novartis is making toward our goal of protecting all age groups against meningococcal disease."
"In the US, Novartis intends to submit a supplemental Biologics License Application (sBLA) based on these pivotal data to the US Food and Drug Administration (FDA) by year-end. If approved, Menveo will be the only meningococcal quadrivalent conjugate vaccine that could be administered to infants 2 months of age and older. This label claim extension will be also submitted in Europe and in other parts of the world," Novartis says.
Menveo Clinical Trial Results and Design
The Phase III, randomized, open-label, multi-center, parallel-group study is the first to evaluate and present results for a meningococcal quadrivalent conjugate vaccine in infants. The study involved 4,545 healthy infants in trial sites throughout the US and Latin America. Only data from the US trial sites were presented at IDSA. Infants were randomized 2:1 to receive routine infant vaccinations (DTaP, IPV, HBV, Hib, pneumococcal) alone or together with Menveo at 2, 4, 6 and 12 months of age. The primary objectives of the study were to assess the safety and tolerability of four doses of Menveo when given alone or co-administered with routine infant vaccines and, in a subset, to assess the immune response to the vaccine[1].
The percentage of infants who achieved a protective immune response was 67 percent for serogroup A, 97 percent for serogroup C, and 96 percent for serogroups W135 and Y when measured at 7 months of age, one month after the third dose. One month after the fourth dose at 12 months of age, the percentages were 94 percent for serogroup A, 98 percent for serogroup C, and 100 percent for serogroups W135 and Y. The immune response was measured by the percentage of participants achieving serum bactericidal antibody titers >1:8, using human complement (hSBA). In addition, responses to routine infant vaccine antigens, when co-administered with Menveo, were generally similar, except for a slightly lower immune response to pneumococcal serotype 6B after the infant series[1].
When given alone, Menveo was well tolerated, with a reactogenicity and safety profile similar to routine infant vaccines. Co-administration of Menveo with routine infant immunizations neither resulted in increased frequency nor severity of systemic reactions or other safety events. The most common side effects in both groups were sleepiness, irritability, persistent crying, changed eating habits, rash, and gastrointestinal events. Rates of fever >38° C were similar in both groups with the majority of cases resolving within 24-48 hours. Incidence of serious adverse events was not different between the groups.
Discussion about this post