EMEA-003155-PIP01-21 - paediatric investigation plan

Pneumococcal polysaccharide serotype 3

Pneumococcal Polysaccharide Serotype 8

Pneumococcal Polysaccharide Serotype 15C

Pneumococcal polysaccharide serotype 6A

Pneumococcal Polysaccharide Serotype 15A

Pneumococcal Polysaccharide Serotype 16F

Pneumococcal polysaccharide serotype 19A

Pneumococcal Polysaccharide Serotype 23A

Pneumococcal Polysaccharide Serotype 24F

Pneumococcal Polysaccharide Serotype 17F

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

Pneumococcal polysaccharide serotype 10A

Pneumococcal polysaccharide serotype 12F

Pneumococcal Polysaccharide Serotype 20

Pneumococcal Polysaccharide Serotype 31

Pneumococcal Polysaccharide Serotype 35B

Pneumococcal polysaccharide serotype 7F

Pneumococcal Polysaccharide Serotype 22F

Pneumococcal Polysaccharide Serotype 9N

Pneumococcal polysaccharide serotype 11A

Pneumococcal Polysaccharide Serotype 23B

Key facts

• Active Substance:
  • Pneumococcal polysaccharide serotype 3
  • Pneumococcal Polysaccharide Serotype 8
  • Pneumococcal Polysaccharide Serotype 15C
  • Pneumococcal polysaccharide serotype 6A
  • Pneumococcal Polysaccharide Serotype 15A
  • Pneumococcal Polysaccharide Serotype 16F
  • Pneumococcal polysaccharide serotype 19A
  • Pneumococcal Polysaccharide Serotype 23A
  • Pneumococcal Polysaccharide Serotype 24F
  • Pneumococcal Polysaccharide Serotype 17F
  • pneumococcal polysaccharide serotype 33F – diphtheria CRM197 conjugate (15-valent pneumococcal polysaccharide conjugate vaccine [V114])
  • Pneumococcal polysaccharide serotype 10A
  • Pneumococcal polysaccharide serotype 12F
  • Pneumococcal Polysaccharide Serotype 20
  • Pneumococcal Polysaccharide Serotype 31
  • Pneumococcal Polysaccharide Serotype 35B
  • Pneumococcal polysaccharide serotype 7F
  • Pneumococcal Polysaccharide Serotype 22F
  • Pneumococcal Polysaccharide Serotype 9N
  • Pneumococcal polysaccharide serotype 11A
  • Pneumococcal Polysaccharide Serotype 23B
• Therapeutic area:
  Vaccines
• Decision number:
  P/0485/2022
• PIP number:
  EMEA-003155-PIP01-21
• 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
• Contact for public enquiries:

  Merck Sharp & Dohme (Europe) Inc.

  Tel.: [phone]; E-mail: [e-mail]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  02/12/2022

Decision

P/0485/2022: EMA decision of 2 December 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for Pneumococcal Polysaccharide Serotype 3...(EMEA-003155-PIP01-21)

AdoptedReference Number: EMA/871501/2022