The Ministry of Food and Drug Safety said it imposed an administrative penalty equivalent to a one-month suspension of clinical trials on Sanofi Pasteur Korea for the violation of labeling requirements in their ongoing meningococcal conjugate vaccine study.

As a result of the violation of the Pharmaceutical Affairs Act, the company's clinical trial operations will be suspended from Sunday until Nov. 22, the ministry said.

However, the regulator refrained from explaining the details of the labeling violation.

The vaccine in the suspended trial in question is believed to be MenQuadfi, an FDA-approved vaccine designed for active immunization against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y.

MenQuadfi has been approved in over 40 countries and regions, including Europe and the U.S. In the U.S., it is approved for use in individuals aged two and above, while in Europe and other regions, it is approved for those aged 12 months and older.

MenQuadfi is a vaccine developed as a successor to Menactra, which Sanofi has been selling since it was approved in Korea in 2014.

While Menactra contains an antigen amount of 4µg and utilizes diphtheria toxoid as its conjugate protein, MenQuadfi contains an antigen amount of 10µg and uses tetanus toxoid.

Earlier this year, Sanofi also launched the vaccine in Japan based on the phase 2 non-inferiority trial conducted in the country.

Sanofi Pasteur confirmed the MFDS’ trial suspension order.

“Sanofi Pasteur was penalized by the Ministry of Food and Drug Safety with a one-month clinical trial suspension for violating the labeling of an investigational drug,” an official at Sanofi Pasteur Korea said.

“We evaluate that the labeling of an investigational drug has no impact on the outcome and safety of this clinical trial. Sanofi respects the decision of the MFDS and will do our best to comply with clinical trial regulations.”