EMEA-003359-PIP01-22 - paediatric investigation plan

recombinant neisseria meningitis group B Protein 936-741

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

recombinant neisseria meningitis group B Protein 287-953

meningococcal group A oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein

recombinant Neisseria meningitidis group B fHbp 2-3-1.13NB fusion protein

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

meningococcal group C oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein

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

recombinant neisseria meningitis group B Protein 961c (MenACWY-7B vaccine)

Key facts

• Active substance:
  • recombinant neisseria meningitis group B Protein 936-741
  • meningococcal group W-135 oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein
  • recombinant neisseria meningitis group B Protein 287-953
  • meningococcal group A oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein
  • recombinant Neisseria meningitidis group B fHbp 2-3-1.13NB fusion protein
  • outer membrane vesicles (OMV) from n. meningitidis strain NZ 98/254
  • meningococcal group C oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein
  • meningococcal group Y oligosaccharides conjugated to corynebacterium diphtheriae CRM197 protein (MenABCWY)
  • recombinant neisseria meningitis group B Protein 961c (MenACWY-7B vaccine)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0404/2023
• PIP number:
  EMEA-003359-PIP01-22
• Pharmaceutical form(s):
  Powder and suspension for suspension for injection
• Condition(s) / indication(s):
  Prevention of Meningococcal disease
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  27/10/2023
• Compliance check done:
  No

Decision

P/0404/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a waiver for recombinant Neisseria meningitis group B Protein 936-741......(MenACWY-7B vaccine) (EMEA-003359-PIP01-22)

Adopted Reference Number: EMA/400645/2023