EMA/PE/0000222938 - paediatric investigation plan

Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein (MenABCWY)

Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein

Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein

Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein

recombinant Neisseria meningitidis serogroup B protein 1

recombinant Neisseria meningitidis serogroup B protein 2

recombinant Neisseria meningitidis serogroup B protein 3

Neisseria meningitidis serogroup B Protein-based active substance (MenPenta vaccine)

Key facts

• Active substance:
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein (MenABCWY)
  • Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein
  • Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein
  • Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein
  • recombinant Neisseria meningitidis serogroup B protein 1
  • recombinant Neisseria meningitidis serogroup B protein 2
  • recombinant Neisseria meningitidis serogroup B protein 3
  • Neisseria meningitidis serogroup B Protein-based active substance (MenPenta vaccine)
• Therapeutic area:
  Vaccines
• Decision number:
  EMA/PE/0000222938
• PIP number:
  EMA/PE/0000222938
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of meningococcal disease (serogroups A, B, C, W and Y)
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000222938 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for Neisseria Meningitidis Group A Polysaccharide....(MenPenta vaccine)

Adopted Reference Number: EMADOC-1700519818-1859737