Sanofi has reported that its single-dose vaccine, MenQuadfi, met all primary and secondary endpoints in Phase III MEQ00065 study in healthy toddlers for preventing invasive meningococcal disease (IMD), a fatal illness.
The head-to-head comparative, multi-centre Phase III trial was carried out in Germany, Finland and Denmark.
It compared the immune response against meningococcal serogroup C and analysed the safety of MenQuadfi in healthy toddlers aged 12 to 23 months as against quadrivalent ACWY vaccine, Nimenrix and monovalent C vaccine, NeisVac-C.
Trial data showed that MenQuadfi stimulated greater immune responses to serogroup C according to geometric mean antibody titers (GMTs) versus NeisVac-C in healthy toddlers.
Furthermore, the trial demonstrated that switching from monovalent C to MenQuadfi in toddlers can be done with no compromise to serogroup C protection.
Compared to Nimenrix, MenQuadfi had superior immune responses to serogroup C depending on GMTs as well as seroprotection rates.
Sanofi noted that MenQuadfi is the first quadrivalent ACWY vaccine to achieve a superior immune response against this serogroup in this population.
The three vaccines tested in the trial had comparable safety profiles.
Sanofi will publish complete data from the Phase III trial in the fourth quarter of this year.
Sanofi Pasteur global medical head Dr Su-Peing Ng said: “The results of our head-to-head Phase III 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.
“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.”
The US Food and Drug Administration currently licensed the vaccine for preventing IMD in toddlers aged two years or above.
MenQuadfi is also approved by the European Commission, Iceland and UK, among other countries, for preventing invasive meningococcal ACWY disease in toddlers aged two years or above.
The vaccine can be given as a single dose and supports primary and booster inoculation to a broader age group, from two-year toddlers to children, adolescents, adults and even the elderly.
Last month, Sanofi Pasteur and Translate Bio commenced a Phase I clinical trial in the US to assess an investigational mRNA-based vaccine candidate against seasonal influenza.