WHO ICTRP trial
A Phase 2 Safety and Immunogenicity Study of a Monovalent Pneumococcal Conjugate…
CTIS2023-505154-18-00 · EU Clinical Trials Information System · Recruiting
Key facts
| Trial ID | CTIS2023-505154-18-00 |
|---|---|
| Public title | A Phase 2 Safety and Immunogenicity Study of a Monovalent Pneumococcal Conjugate Candidate in Healthy Toddlers |
| Scientific title | C4801002 - A Phase 2, Randomized, Open-Label Trial to Describe the Safety and Immunogenicity of A Monovalent Pneumococcal Conjugate Candidate Administered As a 2-Dose Series in Healthy Toddlers 12 Through 15 Months of Age Who Previously Received PCV10 Primary Series in the European Union - C4801002 |
| Primary sponsor | Pfizer Inc. |
| Secondary sponsors | Pfizer Europe Ma EEIG |
| Registry | EU Clinical Trials Information System |
| Recruitment status | Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use - (Phase IV): no |
| Countries | Finland;Poland |
| Conditions | Pneumococcal Infections;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]-Diseases [C] - Bacterial Infections and Mycoses [C01] |
| Interventions | Product Name: PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 CONJUGATED TO CRM197 ADSORBED ON ALUMINIUM PHOSPHATE,Product Code: SUB199854,Pharmaceutical Form: SUSPENSION FOR INJECTION,Other descriptive name: mPnC control,Strength: 2.2µg /… |
| Registration date | Jul 14, 2023 |
| Target size | 100 |
| Registry page | euclinicaltrials.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: