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NCT05715918
Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 of Children at the Age of 12-17 Years Inclusive"
Phase 3 trial testing Vaccine for intramuscular injection in Vaccine in 300 participants. Status unknown.
1 December 2023
Quick facts
| Lead sponsor | Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 300 |
| Start date | 1 April 2022 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 February 2024 |
| Sites | 4 locations across Russia |
Drugs / interventions tested
- Vaccine for intramuscular injection — full drug profile →
- Placebo comparator (without active ingredient) for intramuscular injection
Conditions studied
- Vaccine — all drugs for Vaccine →
Sponsor
Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products — full company profile →
Who can join
Adults 12 to 17, any sex, with Vaccine. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R\&D IBP RAS", of childrens aged 12-17" (Clinical trials, phase III). Study purpose is to assess the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified coronavirus vaccine of chidrens aged 12-17
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05715918
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products trials
Trials by the same sponsor.
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- NCT05765773 — An Open Comparative Study of the Effectiveness and Incomparable Study of the Immunogenicity and Safety of the Vaccine (C · Phase 2 · completed
- NCT05046548 — This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inacti · Phase 1, PHASE2 · completed
- NCT05083039 — Observational Program, Study the Preventive Efficacy of the BiVac Polio Vaccine Against the Incidence of Acute Respirato · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05715918 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
- Last refreshed: 7 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05715918.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing