EMEA-002814-PIP02-21-M01 - paediatric investigation plan

Neisseria meningitidis serogroup B fHbp subfamily A

Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein

Neisseria meningitidis serogroup B fHbp subfamily B

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

Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein

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

Key facts

• Active Substance:
  • Neisseria meningitidis serogroup B fHbp subfamily A
  • Neisseria meningitidis group C polysaccharide conjugated to tetanus toxoid carrier protein
  • Neisseria meningitidis serogroup B fHbp subfamily B
  • Neisseria meningitidis group W-135 polysaccharide conjugated to tetanus toxoid carrier protein
  • Neisseria meningitidis group Y polysaccharide conjugated to tetanus toxoid carrier protein
  • Neisseria meningitidis group A polysaccharide conjugated to tetanus toxoid carrier protein (MenABCWY)
• Therapeutic area:
  Vaccines
• Decision number:
  P/0055/2023
• PIP number:
  EMEA-002814-PIP02-21-M01
• Pharmaceutical form(s):
  Powder and suspension for suspension for injection
• Condition(s) / indication(s):
  Prevention of invasive disease caused by Neisseria meningitidis group A, B, C, W and Y
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Pfizer Europe MA EEIG

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/01/2023

Decision

P/0055/2023 : EMA decision of 30 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for neisseria meningitidis serogroup B fHbp subfamily A / Neisseria meningitidis group C....(EMEA-002814-PIP02-21- M01)

AdoptedReference Number: EMA/21391/2023