EMEA-001260-PIP01-11-M03 - paediatric investigation plan

outer membrane vesicles (OMV) from n. meningitidis strain NZ 98/254

recombinant neisseria meningitis group B Protein 936-741

meningococcal group W-135 oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein

meningococcal group A oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein

meningococcal group C oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein

recombinant neisseria meningitis group B Protein 287-953

recombinant Neisseria meningitis group B Protein 961c

meningococcal group Y oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein (MenABCWY)

Key facts

• Active substance:
  • outer membrane vesicles (OMV) from n. meningitidis strain NZ 98/254
  • recombinant neisseria meningitis group B Protein 936-741
  • meningococcal group W-135 oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein
  • meningococcal group A oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein
  • meningococcal group C oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein
  • recombinant neisseria meningitis group B Protein 287-953
  • recombinant Neisseria meningitis group B Protein 961c
  • meningococcal group Y oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein (MenABCWY)
• Therapeutic area:
  Infections and infestations
• Decision number:
  P/0118/2024
• PIP number:
  EMEA-001260-PIP01-11-M03
• Pharmaceutical form(s):
  Powder and suspension for suspension for injection
• Condition(s) / indication(s):
  Prevention of meningococcal meningitis
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  12/04/2024
• Compliance check done:
  No

Decision

P/0118/2024: EMA decision of 12 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for outer membrane vesicles (OMV) from N. meningitidis Strain NZ 98/254..(EMEA-001260-PIP01-11-M03)

Adopted Reference Number: EMA/114604/2024