WHO ICTRP trial
Clinical Study Evaluating the immune responses and safety of lower dose COVID-19…
EUCTR2021-005043-71-NL · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2021-005043-71-NL |
|---|---|
| Public title | Clinical Study Evaluating the immune responses and safety of lower dose COVID-19 mRNA Vaccination in children (CoVacc) |
| Scientific title | A Phase 2, Comparative Randomised Trial to Evaluate the impact of reduced COVID-19 mRNA vaccination regimens on immunological responses and reactogenicity in paediatric subjects with and without prior SARS-CoV-2 infection - Immunogenicity and reactogenicity of reduced COVID-19 mRNA vaccination… |
| Primary sponsor | University Medical Center Utrecht |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| 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 | Netherlands |
| Conditions | Healthy volunteers (paediatric subjects) with or without prior SARS-CoV-2 infection MedDRA version: 23.1 Level: LLT Classification code 10084464 Term: COVID-19 immunization System Organ Class: 100000004865 ;Therapeutic area: Diseases [C]… |
| Interventions | Trade Name: Comirnaty Pharmaceutical Form: Concentrate for dispersion for injection |
| Registration date | Sep 10, 2021 |
| Target size | 400 |
| Secondary IDs | EU-COVPT-1 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: