EMA/PE/0000221419 - paediatric investigation plan

pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 8 – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 15C – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 6A – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 15A – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 16F – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 19A – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 23A – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 24F – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 17F – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 33F – diphtheria CRM197 conjugate (15-valent pneumococcal polysaccharide conjugate vaccine [V114])

pneumococcal polysaccharide serotype 10A – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 12F – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 20A – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 31 – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 35B – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 7F – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 22F – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 9N – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 11A – diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 23B – diphtheria CRM197 conjugate (V116)

Key facts

• Active substance:
  • pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 8 – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 15C – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 6A – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 15A – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 16F – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 19A – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 23A – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 24F – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 17F – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 33F – diphtheria CRM197 conjugate (15-valent pneumococcal polysaccharide conjugate vaccine [V114])
  • pneumococcal polysaccharide serotype 10A – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 12F – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 20A – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 31 – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 35B – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 7F – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 22F – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 9N – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 11A – diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 23B – diphtheria CRM197 conjugate (V116)
• Therapeutic area:
  Vaccines
• Decision number:
  EMA/PE/0000221419
• PIP number:
  EMA/PE/0000221419
• Pharmaceutical form(s):
  Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  Prevention of disease caused by Streptococcus pneumoniae
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

EMA/PE/0000221419 : EMA decision of 6 December 2024 on the acceptance of a modification of an agreed paediatric investigation plan for Pneumococcal Polysaccharide Serotype 3 – Diphtheria CRM197 Conjugate...

Adopted Reference Number: EMADOC-1700519818-1793577