MHRA paediatric investigation plan
TBD (Pneumococcal Polysaccharide Serotype 3 - Diphtheria CRM197 Conjugate)
MHRA paediatric investigation plan MHRA-100920-PIP01-23-M01 (update) · Modification
Key facts
| PIP number | MHRA-100920-PIP01-23-M01 (update) |
|---|---|
| Product names | TBD, CAPVAXIVE®, CAPVAXIVE™ |
| Active substances | Pneumococcal Polysaccharide Serotype 3 - Diphtheria CRM197 Conjugate, Pneumococcal Polysaccharide Serotype 6A - Diphtheria CRM197 Conjugate, Pneumococcal Polysaccharide Serotype 7F - Diphtheria CRM197 Conjugate, Pneumococcal Polysaccharide Serotype 19A - Diphtheria CRM197 Conjugate, Pneumococcal Polysaccharide Serotype 22F - Diphtheria CRM197 Conjugate, Pneumococcal Polysaccharide Serotype 33F - Diphtheria CRM197 Conjugate, Pneumococcal Polysaccharide Serotype 8 - Diphtheria CRM197 Conjugate, Pneumococcal Polysaccharide Serotype 9N - Diphtheria CRM197 Conjugate, Pneumococcal Polysaccharide Serotype 10A - Diphtheria CRM197 Conjugate, Pneumococcal Polysaccharide Serotype 11A - Diphtheria CRM197 Conjugate, Pneumococcal Polysaccharide Serotype 12F - Diphtheria CRM197 Conjugate, Pneumococcal Polysaccharide Serotype 17F - Diphtheria CRM197 Conjugate and 9 more |
| Therapeutic areas | Vaccines |
| Conditions | Prevention of disease caused by Streptococcus pneumoniae. |
| Decision | PM: decision on the application for modification of an agreed paediatric investigation plan. |
| Compliance check outcome | Partial |
| Published | Jan 6, 2025 |
| 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: