EMEA-000278-PIP01-08-M01 - paediatric investigation plan

purified diphtheria toxoid

purified tetanus toxoid

Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)]

purified polyribosylribitol phosphate capsular polysaccharide of Haemophilus influenzae type b covalently bound to Tetanus protein (PRP-T)

Inactivated Type 1 Poliovirus (Mahoney)

Inactivated Type 2 Poliovirus (MEF-1)

Inactivated Type 3 Poliovirus (Saukett)

Key facts

• Invented name:
  PEDIACEL
• Active substance:
  • purified diphtheria toxoid
  • purified tetanus toxoid
  • Five component acellular pertussis [Purified Pertussis Toxoid (PT), Purified Filamentous Haemagglutinin (FHA), Purified Fimbriae Types 2 and 3 (FIM), and Purified Pertactin (PRN)]
  • purified polyribosylribitol phosphate capsular polysaccharide of Haemophilus influenzae type b covalently bound to Tetanus protein (PRP-T)
  • Inactivated Type 1 Poliovirus (Mahoney)
  • Inactivated Type 2 Poliovirus (MEF-1)
  • Inactivated Type 3 Poliovirus (Saukett)
• Therapeutic area:
  Vaccines
• Decision number:
  P/64/2009
• PIP number:
  EMEA-000278-PIP01-08-M01
• Pharmaceutical form(s):
  • Suspension for injection in pre-filled syringe
  • Suspension for injection in a vial
• Condition(s) / indication(s):
  Active immunisation against infectious diseases caused by Haemophilus influenzae type b, Corynebacterium diphtheriae, Clostridium tetani, Bordetella pertussis and poliovirus types 1, 2 and 3
• 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:
  31/03/2009
• Compliance check done:
  Yes
• Compliance procedure number:
  EMEA-C-000278-PIP01-08-M01
• Compliance opinion date:
  18/09/2009
• Compliance outcome:
  Positive

Decision

P/64/2009: Purified diphtheria toxoid/Purified tetanus toxoid/Five component acellular pertussis [Purified Pertussis Toxoid, Purified Filamentous Haemagglutinin, Purified Fimbriae Types 2 and 3, and Purified Pertactin]/ ...

Adopted Reference Number: EMEA/160106/2009