EMEA-001260-PIP01-11-M02 - 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:
  Vaccines
• Decision number:
  P/0437/2022
• PIP number:
  EMEA-001260-PIP01-11-M02
• Pharmaceutical form(s):
  Powder and suspension for suspension for injection
• Condition(s) / indication(s):
  Prevention of meningococcal meningitis
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  GlaxoSmithKline Biologicals SA

  E-mail: [e-mail]; Tel: [phone]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2022

Decision

P/0437/2022: EMA decision of 28 October 2022 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-M02)

AdoptedReference Number: EMA/808316/2022