MHRA-100701-PIP01-22-M01 (update)

Key Facts

Active Substance
  • Outer Membrane Vesicles (OMV) from N. meningitidis Strain NZ 98/254
  • Recombinant Neisseria meningitis group B Protein 936-741
  • Meningococcal group W-135 oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Meningococcal group A oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Meningococcal group C oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
  • Recombinant Neisseria meningitis group B Protein 287- 953
  • Recombinant Neisseria meningitis group B Protein 961c
  • Meningococcal group Y oligosaccharides conjugated to Corynebacterium diphtheriae CRM197 protein
Invented Name
Not yet available
PIP Number MHRA-100701-PIP01-22-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • powder and suspension for suspension for injection
Therapeutic area
Therapeutic area:
  • Vaccines
Conditions / Indications
Conditions / Indications:
  • Prevention of meningococcal meningitis
Route(s) of administration
Route(s) of administration:
  • intramuscular
PIP applicant
  • GlaxoSmithKline UK Limited
  • Country United Kingdom
  • Tel 02080475000
  • Email oax52639@gsk.com
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Outer Membrane Vesicles (OMV) from N. meningitidis Strain NZ 98/254Recombinant Neisseria meningitis group B Protein 936-741Meningococcal group W-135 oligosaccharides conjugated toCorynebacterium diphtheriae CRM197 proteinMeningococcal group A oligosaccharides conjugated to Corynebacteriumdiphtheriae CRM197 proteinMeningococcal group C oligosaccharides conjugated to Corynebacteriumdiphtheriae CRM197 proteinRecombinant Neisseria meningitis group B Protein 287- 953Recombinant Neisseria meningitis group B Protein 961cMeningococcal group Y oligosaccharides conjugated to Corynebacterium diphtheriaeCRM197 protein.pdf
Published Date 30/06/2023