MHRA paediatric investigation plan
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). (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).)
MHRA paediatric investigation plan MHRA-100798-PIP01-22 · Agreement
Key facts
| PIP number | MHRA-100798-PIP01-22 |
|---|---|
| Active substances | 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… |
| Therapeutic areas | Vaccines, Other: mRNA-vaccine |
| Conditions | Prevention of cytomegalovirus (CMV) infection |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Oct 28, 2024 |
| MHRA record | cms.mhra.gov.uk |
About MHRA paediatric investigation plans
A paediatric investigation plan sets out the studies a company must run in children to support authorisation of a medicine in the UK, or records a waiver or deferral.
Source: UK Medicines and Healthcare products Regulatory Agency (MHRA). Contains public sector information licensed under the Open Government Licence v3.0 · Source date: