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NCT05779020
Immunogenicity and Safety of Butantan Quadrivalent Influenza Vaccine (Split Virion, Inactivated) in Infants and Children .
Phase 3 trial testing Quadrivalent Influenza Vaccine (split virion, inactivated) in Influenza, Human in 1,373 participants. Completed in 2 August 2025.
12 September 2024
Quick facts
| Lead sponsor | Butantan Institute |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 1,373 |
| Start date | 25 April 2023 |
| Primary completion | 12 September 2024 |
| Estimated completion | 2 August 2025 |
| Sites | 10 locations across Brazil |
Drugs / interventions tested
- Quadrivalent Influenza Vaccine (split virion, inactivated)
- Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Victoria lineage
- Trivalent Influenza Vaccine (split virion, inactivated) containing Influenza B virus - Yamagata lineage
Conditions studied
- Influenza, Human — all drugs for Influenza, Human →
Sponsor
Butantan Institute
Who can join
Adults 6 Months to 35 Months, any sex, with Influenza, Human. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase III Randomized Clinical Trial, blind, multicenter, with active controls, to evaluate the immunogenicity and safety of the Quadrivalent Influenza Vaccine (split virion, inactivated) from Instituto Butantan, in two dose scheme (0.25ml and 0.50ml), in infants and children under 3 years of age.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05779020
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Influenza, Human
Currently open trials in the same condition.
- NCT07204964 — A Study to Evaluate the Immune Response and Safety of an Influenza Vaccine in Adults 18 Years of Age and Above · Phase 2 · active not recruiting
- NCT07121192 — A Study to Assess the Immune Response and Safety of a Vaccine Against Influenza in Adults 18 Years of Age and Older · Phase 2 · active not recruiting
- NCT05921448 — Vaccine Pandemic Preparedness Through Airway Immunology Characterization · EARLY_PHASE1 · active not recruiting
- NCT06573008 — Study of GP681 Tablets Compared With Placebo in Patients With Influenza at High Risk of Influenza Complications · Phase 3 · recruiting
- NCT06622590 — Phase I Clinical Trial of Quadrivalent Influenza Virus Split Vaccine · Phase 1 · active not recruiting
Other Butantan Institute trials
Trials by the same sponsor.
- NCT06842173 — Safety and Immunogenicity of the Monovalent Influenza Vaccine A (H5N8) (Inactivated, Fragmented and Adjuvanted) in Adult · Phase 1, PHASE2 · recruiting
- NCT05354024 — Phase II/III Randomized Clinical Trial of Booster Dose of COVID-19 (Recombinant, Inactivated) Vaccine · Phase 2, PHASE3 · completed
- NCT05710224 — Clinical Bridging Study Between V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccin · Phase 2 · completed
- NCT04650399 — A Multicenter Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Vaccine in Adolescents · Phase 3 · completed
- NCT04993209 — Clinical Trial of the COVID-19 Vaccine (Recombinant, Inactivated) in Brazil · Phase 1 · 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 NCT05779020 (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 Butantan Institute
- Last refreshed: 19 September 2025
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/NCT05779020.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing