MHRA paediatric investigation plan
Outer Membrane Vesicles (OMV) from N. meningitidis Strain NZ 98/254 (Outer Membrane Vesicles (OMV) from N. meningitidis Strain NZ 98/254)
MHRA paediatric investigation plan MHRA-100701-PIP01-22-M01 (update) · Modification
Key facts
| PIP number | MHRA-100701-PIP01-22-M01 (update) |
|---|---|
| Active substances | Outer Membrane Vesicles (OMV) from N. meningitidis Strain NZ 98/254, Recombinant Neisseria meningitis group B Protein 936-741, Meningococcal group W-135 oligosaccharides conjugated to, Corynebacterium diphtheriae CRM197 protein, Meningococcal group A oligosaccharides conjugated to Corynebacterium, diphtheriae CRM197 protein, Meningococcal group C oligosaccharides conjugated to Corynebacterium, Recombinant Neisseria meningitis group B Protein 287- 953, Recombinant Neisseria meningitis group B Protein 961c, Meningococcal group Y oligosaccharides conjugated to Corynebacterium diphtheriae, CRM197 protein |
| Therapeutic areas | Vaccines |
| Conditions | Prevention of meningococcal meningitis |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Published | Jun 30, 2023 |
| 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: