MHRA paediatric investigation plan
9-valent vaccine consisting of the O-antigen polysaccharides of the extraintestinal pathogenic (9-valent vaccine consisting of the O-antigen polysaccharides of the extraintestinal pathogenic)
MHRA paediatric investigation plan MHRA-100030-PIP01-21 · Agreement
Key facts
| PIP number | MHRA-100030-PIP01-21 |
|---|---|
| Active substances | 9-valent vaccine consisting of the O-antigen polysaccharides of the extraintestinal pathogenic, Escherichia coli (ExPEC) serotypes O1A, O2, O4, O6A, O15, O16, O18A, O25B and O75 bioconjugated, to the carrier exoprotein A (EPA), a genetically detoxified protein from Pseudomonas aeruginosa, (ExPEC9V) |
| Therapeutic areas | Vaccines |
| Conditions | Prevention of infections caused by extraintestinal pathogenic Escherichia coli (ExPEC) |
| Decision | P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s) |
| Published | Dec 7, 2022 |
| 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: