MHRA-100798-PIP01-22

Key Facts

Active Substance
Active Substance:
  • CX-000359 mRNA encoding the UL128 protein in the CMV glycoprotein complex pentamer / CX- 000594 mRNA encoding the gL protein in the CMV glycoprotein complex pentamer / CX- 000712 mRNA encoding the UL130 protein in the CMV glycoprotein complex pentamer / CX-005128 mRNA encoding the UL131A protein in the CMV glycoprotein complex pentamer / CX-005282 m-RNA encoding the gH protein in the CMV glycoprotein complex pentamer / CX-000667 mRNA encoding CMV gB (mRNA- 1647).
Invented Name
Not yet available
PIP Number MHRA-100798-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Powder for suspension for injection
Therapeutic area
  • Vaccines
  • Other: mRNA-vaccine
Conditions / Indications
Conditions / Indications:
  • Prevention of cytomegalovirus (CMV) infection
Route(s) of administration
Route(s) of administration:
  • Intramuscular use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):CX-000359 mRNA encoding the UL128 protein in the CMV glycoprotein complex pentamer / CX- 000594 mRNA encoding the gL protein in the CMV glycoprotein complex pentamer / CX- 000712 mRNA encoding the UL130 protein in the CMV glycoprotein complex pentamer / CX-005128 mRNA encoding the UL131A protein in the CMV glycoprotein complex pentamer / CX-005282 m-RNA encoding the gH protein in the CMV glycoprotein complex pentamer / CX-000667 mRNA encoding CMV gB (mRNA- 1647)..pdf
Published Date 28/10/2024