NCT03392207 (FLU-06-IB) is a clinical trial of Seasonal Influenza Vaccine in Influenza, Human, sponsored by Butantan Institute.

Who is sponsoring NCT03392207?

NCT03392207 is sponsored by Butantan Institute.

What drugs are being tested in NCT03392207?

Interventions in NCT03392207: Seasonal Influenza Vaccine.

What condition does NCT03392207 study?

NCT03392207 studies Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Respiratory Tract Infections, Virus Diseases, Vaccines, Physiological Effects of Drugs.

Is NCT03392207 still recruiting?

NCT03392207 is currently completed. Last updated 16 January 2019.

Last reviewed 2019-01-16 · How we verify

NCT03392207: FLU-06-IB

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Active Surveillance for Adverse Events Following Immunization With the Butantan Trivalent Influenza Vaccine (2018)

Completed Last updated 16 January 2019

What this trial tests

trial testing Seasonal Influenza Vaccine in Influenza, Human in 403 participants. Completed in 14 September 2018.

Timeline

23 April 2018

Primary endpoint
17 July 2018

14 September 2018

Quick facts

Lead sponsor	Butantan Institute
Status	Completed
Study type	OBSERVATIONAL
Enrollment	403
Start date	23 April 2018
Primary completion	17 July 2018
Estimated completion	14 September 2018
Sites	2 locations across Brazil

Drugs / interventions tested

Seasonal Influenza Vaccine — full drug profile →

Conditions studied

Influenza, Human — all drugs for Influenza, Human →
Orthomyxoviridae Infections — all drugs for Orthomyxoviridae Infections →
RNA Virus Infections — all drugs for RNA Virus Infections →
Respiratory Tract Infections — all drugs for Respiratory Tract Infections →

Sponsor

Butantan Institute

Who can join

Adults 18 to 130, any sex, with Influenza, Human or Orthomyxoviridae Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale and Background: Since 2013, Butantan Institute has been performing passive pharmacovigilance activities related to its triavalent, fragmented and inactivated vaccine (IB TIV). Objetive: To conduct an active surveillance study focusing on the elderly and health care professionals as part of Butantan pharmacovigilance plan, while passive surveillance activities will continue. The pharmacovigilance plan, via active surveillance, is being implemented in response to WHO requirements for pre-qualification of IB TIV.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Active pharmacovigilance of the seasonal trivalent influenza vaccine produced by Instituto Butantan: A prospective cohort study of five target groups.
Vanni T, Thomé BDC, Oliveira MMM, Gattás VL, et al · · 2021 · PMID 33571237 · DOI 10.1371/journal.pone.0246540

Verify or expand the search:

Other trials of Seasonal Influenza Vaccine

Trials testing the same drug.

NCT03701061 — Durability and Impact of the Seasonal Influenza Vaccine on H5 Induced B Cell Response · Phase 4 · completed

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03392207 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 16 January 2019

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/NCT03392207.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing