EMEA-002221-PIP01-17 - paediatric investigation plan

trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140]

Key facts

• Active substance:
  trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with aluminium phosphate [Clade C gp140]
• Therapeutic area:
  • Infectious diseases
  • Vaccines
• Decision number:
  P/0236/2018
• PIP number:
  EMEA-002221-PIP01-17
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Prevention of human immunodeficiency virus (HIV-1) infection
• Route(s) of administration:
  Intramuscular use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/08/2018
• Compliance check done:
  No

Decision

P/0236/2018: EMA decision of 15 August 2018 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for trimeric, recombinant HIV-1 envelope glycoprotein 140 of Clade C, adjuvanted with alumini

Reference Number: EMA/480855/2018