MenQuadfi® demonstrates superior immune response against serogroup C meningococcal disease in toddlers
- Phase 3 study met primary and secondary endpoints demonstrating MenQuadfi® induced superior immune responses to serogroup C compared to a standard-of-care vaccine in healthy toddlers
- MenQuadfi is the first and only quadrivalent ACWY vaccine to demonstrate superior immune response against serogroup C in toddlers
July 10, 2021
Results from a head-to-head Phase 3 study, evaluating the immune response of MenQuadfi® to serogroup C, one of the main serogroups of invasive meningococcal disease (IMD), compared to Nimenrix® (quadrivalent ACWY vaccine) and NeisVac-C® (monovalent C vaccine) in healthy toddlers, were presented today in an oral session at the 2021 European Congress of Clinical Microbiology and Infectious Disease.
The Phase 3 study met all primary and secondary endpoints, demonstrating that MenQuadfi induced superior immune responses to serogroup C based on geometric mean antibody titers (GMTs*) compared to NeisVac-C - a standard-of-care vaccine - in healthy toddlers. The study shows that a switch from monovalent C to MenQuadfi in toddlers can be achieved without compromising serogroup C protection. The data also showed superior immune responses to serogroup C based on seroprotection rates and GMTs compared to Nimenrix in this population. The safety profiles were comparable between all three vaccines.
“In the last decade there has been an increase in the incidence of invasive meningococcal disease due to serogroups W & Y in Europe,1 demonstrating a need for routine MenACWY vaccination.” said Prof. Markus Knuf, Head of Department for Pediatric and Adolescent Medicine, Worms Clinic, Worms, Germany, “Now that we know that we can help protect against A,C,W and Y serogroups with no compromise on C serogroup protection, I have great hope that routine ACWY vaccination will soon become the standard helping to protect European children from this potentially devastating disease.”
Children under five and adolescents are most at risk from IMD, a rare but potentially deadly disease which can have devastating consequences.2 Up to 20% of survivors of IMD suffer from serious complications such as brain damage or loss of limbs.2,3
Data has shown IMD has an unpredictable and evolving epidemiology.1 Recent trends in Europe suggest a decreasing incidence of IMD cases caused by serogroup B and an increase in serogroups Y and W.1 There has also been a significant increase in the incidence of IMD caused by hypervirulent serogroup W, with a case fatality rate more than twice that of IMD caused by other serogroups.1
“The results of our head-to-head Phase 3 study are clear and add to our robust evidence demonstrating the strong profile of MenQuadfi against meningococcal disease caused by serogroups A, C, W and Y from toddlers to adults,” said Dr. Su-Peing Ng, Global Medical Head, Sanofi Pasteur. “These data represent an important public health milestone in our efforts to advance protection against meningococcal meningitis and in support of the World Health Organization’s ambition to defeat this disease by 2030.”
About the Phase 3 study4,5
MEQ00065 is a head-to-head comparative, multi-center, Phase 3 study conducted in Germany, Finland and Denmark to compare the immune response against meningococcal serogroup C and describe the safety following a single dose of MenQuadfi in healthy meningococcal vaccine-naïve toddlers 12 to 23 months of age compared to Nimenrix or NeisVac-C.
The full results of the Phase 3 MEQ00065 data will be submitted for publication in a peer-reviewed journal Q4 2021.
MenQuadfi benefits from Sanofi’s latest advancements in chemical design and delivers optimized stability while maintaining the vaccine in a convenient, fully liquid presentation.
The vaccine can be administered as a single injection, supporting primary and booster vaccination to a wide age group, ranging from 12-month-old toddlers to children, adolescents, adults, and the elderly. It can also be co-administered with multiple routine pediatric and adolescent vaccines.6
MenQuadfi is approved by the European Commission, Iceland, Liechtenstein, Norway, Australia, Canada, UK, Brazil and Argentina for use as a single dose in individuals 12 months of age and older for the prevention of invasive meningococcal ACWY disease and is currently under review by several health authorities across the world to help meet local immunization efforts. It is licensed by the Food and Drug Administration in the United States for the prevention of invasive meningococcal disease in individuals 2 years of age and older.
* GMT is the criteria that enables to measure the immune response compared to NeisVac-C
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1 Surveillance Atlas of Infectious Diseases. European Centre for Disease Prevention and Control (ECDC). Available at: https://www.ecdc.europa.eu/en/meningococcal-disease/surveillance-and-disease-data/atlas
accessed June 2021.
2 Factsheet about meningococcal disease. European Centre for Disease Prevention and Control (ECDC), https://www.ecdc.europa.eu/en/meningococcal-disease/factsheet#:~:text=In%202016%2C%203%20280%20confirmed,Member%20States%20(Figure%201) accessed June 2021.
3 Beebeejaun, K et al. (2020). Invasive meningococcal disease: Timing and cause of death in England, 2008–2015. Journal of Infection. Available at: https://doi.org/10.1016/j.jinf.2019.12.008 accessed June 2021.
4 EU Clinical Trials register. 2018-003790-10 (MEQ0065) https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003790-10/results accessed June 2021.
5 Clinicaltrials.gov. NCT03890367 (MEQ65) study record Available at: https://clinicaltrials.gov/ct2/show/NCT03890367 accessed June 2021.
6 MenQuadfi Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product- information/menquadfi-epar-product-information_en.pdf. accessed June 2021.