MHRA-101954-PIP01-25

Key Facts

Active Substance
  • N. meningitidis serogroup Y polysaccharide conjugated to Corynebacterium diphtheriae (C. diphtheriae) CRM197 protein
  • N. meningitidis serogroup W polysaccharide conjugated to Corynebacterium diphtheriae (C. diphtheriae) CRM197 protein
  • N. meningitidis serogroup X polysaccharide conjugated to Purified Tetanus Toxoid
  • N. meningitidis serogroup C polysaccharide conjugated to Corynebacterium diphtheriae (C. diphtheriae) CRM197 protein
  • Neisseria meningitidis (N. meningitidis) serogroup A polysaccharide conjugated to Purified Tetanus Toxoid
Invented Name
  • MenFive
  • MenFive
  • MenFive
  • MenFive
  • MenFive
  • MenFive
  • MenFive
  • MenFive
  • SILMEN-5
  • MenFive
  • MenFive
  • MENVAID
  • MenFive
  • MenFive
  • MenFive
PIP Number MHRA-101954-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder and solvent for solution for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of invasive meningococcal disease
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
21/04/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101954-PIP01-25-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):N. meningitidis serogroup Y polysaccharide conjugated to Corynebacterium diphtheriae (C. diphtheriae) CRM197 proteinN. meningitidis serogroup W polysaccharide conjugated to Corynebacterium d.pdf
Published Date 01/05/2026