EMEA-002215-PIP01-17-M03 - paediatric investigation plan

pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 4 - diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 5 - diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 6A- diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 6B - diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 7F - diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 9V - diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 14 - diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 18C - diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 19A - diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 19F - diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 22F - diphtheria CRM197 conjugate

pneumococcal polysaccharide serotype 23F - diphtheria CRM197 conjugate

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

Key facts

• Active Substance:
  • pneumococcal polysaccharide serotype 1- diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 3 - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 4 - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 5 - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 6A- diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 6B - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 7F - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 9V - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 14 - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 18C - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 19A - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 19F - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 22F - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 23F - diphtheria CRM197 conjugate
  • pneumococcal polysaccharide serotype 33F – diphtheria CRM197 conjugate (15-valent pneumococcal polysaccharide conjugate vaccine [V114])
• Therapeutic area:
  Vaccines
• Decision number:
  P/0244/2019
• PIP number:
  EMEA-002215-PIP01-17-M03
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of disease caused by Streptococcus pneumoniae
• Route(s) of administration:
  Intramuscular use
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe), Inc.

  E-mail: [e-mail]; Country: Belgium; Tel. + 33 180 464 738

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  09/08/2021
• Compliance procedure number:
  EMEA-C-002215-PIP01-17-M03
• Compliance opinion date:
  17/12/2021
• Compliance outcome:
  Positive

Decision

P/0343/2021 : EMA decision of 9 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for pneumococcal polysaccharide serotype......(EMEA-002215-PIP01-17-M03)

AdoptedReference Number: EMA/439333/2021