EMEA-002172-PIP02-17-M02 - paediatric investigation plan

monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain

Key facts

• Active substance:
  monovalent, recombinant, replication-incompetent human adenovirus serotype 26-vectored vaccine encoding the pre-fusion conformation-stabilised F protein derived from the RSV A2 strain
• Therapeutic area:
  Infectious diseases
• Decision number:
  P/0442/2022
• PIP number:
  EMEA-002172-PIP02-17-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV)
• Route(s) of administration:
  Intramuscular use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/10/2022
• Compliance check done:
  No

Decision

P/0442/2022 : EMA decision of 28 October 2022 on the acceptance of a modification of an agreed paediatric investigation plan for monovalent, recombinant, replication-incompetent human adenovirus serotype...from the RSV A2 strain (EMEA-002172-PIP02-17-M02)

Adopted Reference Number: EMA/824453/2022