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NCT03927131
Safety and Immunogenicity of the Butantan Quadrivalent Influenza Vaccine
Phase 3 trial testing QIV-IB in Influenza, Human in 5,822 participants. Completed in 13 March 2024.
13 October 2023
Quick facts
| Lead sponsor | Butantan Institute |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 5,822 |
| Start date | 12 May 2021 |
| Primary completion | 13 October 2023 |
| Estimated completion | 13 March 2024 |
| Sites | 12 locations across Brazil |
Drugs / interventions tested
- QIV-IB — full drug profile →
- TIVV-IB — full drug profile →
- TIVY-IB
- QIV-IB Lot A — full drug profile →
- QIV-IB Lot B — full drug profile →
- QIV-IB Lot C — full drug profile →
Conditions studied
- Influenza, Human — all drugs for Influenza, Human →
Sponsor
Butantan Institute
Who can join
3 and older, any sex, with Influenza, Human. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Studies have shown that a broader spectrum influenza vaccine may help in reducing the influenza burden of disease. Butantan Institute is currently developing a quadrivalent influenza vaccine candidate. This study is will provide safety and immunogenicity data on this quadrivalent influenza vaccine candidate. The study will be conducted in an open population of healthy participants (3 years old and above) recruited in different clinical sites in Brazil and will be adequately powered to assess safety, immune response (measured by GMT HI antibodies) to each viral strain in the vaccines and lot-to-lot consistency.
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 NCT03927131
- 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
- NCT05779020 — Immunogenicity and Safety of Butantan Quadrivalent Influenza Vaccine (Split Virion, Inactivated) in Infants and Children · Phase 3 · completed
- 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
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 NCT03927131 (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: 21 February 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/NCT03927131.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing