WHO ICTRP trial
A Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of…
EUCTR2020-005720-11-Outside-EU/EEA · EU Clinical Trials Register
Key facts
| Trial ID | EUCTR2020-005720-11-Outside-EU/EEA |
|---|---|
| Public title | A Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive |
| Scientific title | A Randomized, Observer-blind, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Different Dose Levels of Ad26.COV2.S Administered as a One- or Two-dose Regimen in Healthy Adolescents From 12 to 17 Years Inclusive - HORIZON 2 |
| Primary sponsor | Janssen Vaccines & Prevention B.V. |
| Registry | EU Clinical Trials Register |
| 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 | Argentina;Brazil;India;Mexico;South Africa |
| Conditions | Healthy Volunteers (Prevention of SARS-CoV-2-mediated COVID-19) MedDRA version: 23.1 Level: LLT Classification code 10084465 Term: COVID-19 vaccination System Organ Class: 100000004865 ;Therapeutic area: Diseases [C] - Virus Diseases [C02] |
| Interventions | Product Name: Ad26.COV2.S Product Code: VAC31518 Pharmaceutical Form: Suspension for injection INN or Proposed INN: Not available Current Sponsor code: VAC31518 Other descriptive name: Ad26.COV2.S Concentration unit: billion organisms/ml… |
| Registration date | Apr 22, 2021 |
| Secondary IDs | VAC31518COV3006 |
| Registry page | clinicaltrialsregister.eu |
At a glance
- No Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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: