EMEA-003379-PIP01-22 - 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:
  P/0445/2023
• PIP number:
  EMEA-003379-PIP01-22
• Pharmaceutical form(s):
  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/0445/2023 : EMA decision of 27 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Neisseria meningitidis group A.....(MenPenta vaccine) (EMEA-003379-PIP01-22)

Adopted Reference Number: EMA/470009/2023