A trial of a new vaccine to protect against menigococcal meningitis in infants.

• Research type

  Research Study

• Full title

  A parallel-group prevention, Phase II, partially blinded, multi-stage study to investigate the immunogenicity and safety of Pentavalent Meningococcal ABCYW Vaccine formulations compared with licensed meningococcal vaccines when administered alone in healthy children (2 to 9 years of age) or concomitantly with routine pediatric vaccines in toddlers (12 to 15 months of age) and infants (2 months of age).

• IRAS ID

  1010970

• Contact name

  Patrick Maury

• Contact email

  Patrick.Maury@Sanofi.com

• Sponsor organisation

  Sanofi Pasteur Inc.

• Eudract number

  2023-510465-10

• Research summary

  Sanofi is conducting a study investigating a novel vaccine that is being developed for preventing invasive meningococcal diseases (IMDs) caused by Neisseiria (N.). meningitidis serogroups A, B, C, W, and Y. This is to answer the need of a vaccine providing protection against the five most epidemiologically relevant N. meningitidis serogroups worldwide (A, B, C, W, and Y) and to reduce the need of multiple injections with multiple vaccines, the MenPenta vaccine is developed as a combination vaccine using meningococcal ACYW-TT conjugate antigens of the licensed MenQuadfi vaccine and the investigational multicomponent meningococcal B antigens (Sanofi MenB investigational vaccine). This VAN00013 study is the first study of Sanofi’s Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age.

  The aim of the study is to assess 2 formulations of the MenPenta vaccine compared to licensed meningococcal vaccines when administered alone in:
  • Stage 1: Children 2 to 9 years
  • Stage 2: Toddlers 12-15 months (given concomitantly with routine paediatric vaccines)
  • Stage 3: Infants 2 months

  This study will also allow the selection of the optimal antigen dose combination and the selection of the lead candidate formulation to be carried forward in the program. The study will be run in the UK (only for stage 3), EU, South and Central America regions and Turkey.

  Approximately 750 participants are planned to take part, among them, a total of 450 infants, 2 months of age are planned to take part in stage 3. The total study duration will be approximately 16-19 months in stage 3.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  25/LO/0014

• Date of REC Opinion

  24 Jan 2025

• REC opinion

  Further Information Favourable Opinion