Who is sponsoring NCT02104869?

NCT02104869 is sponsored by Butantan Institute.

What drugs are being tested in NCT02104869?

Interventions in NCT02104869: Trivalent influenza vaccine (inactivated and fragmented)..

What condition does NCT02104869 study?

NCT02104869 studies Human Influenza.

Is NCT02104869 still recruiting?

NCT02104869 is currently completed. Last updated 20 July 2015.

Last reviewed 2015-07-20 · How we verify

NCT02104869

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

Open Label Parallel Randomized Clinical Trial to Evaluate the Immunogenicity of Three Regimens of the Trivalent Influenza Vaccine (Inactivated and Fragmented) in Kidney Transplant Recipients

Completed Phase 4 Last updated 20 July 2015

What this trial tests

Phase 4 trial testing Trivalent influenza vaccine (inactivated and fragmented). in Human Influenza in 195 participants. Completed in 1 March 2015.

Timeline

1 April 2014

Primary endpoint
1 August 2014

1 March 2015

Quick facts

Lead sponsor	Butantan Institute
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	195
Start date	1 April 2014
Primary completion	1 August 2014
Estimated completion	1 March 2015
Sites	1 location across Brazil

Drugs / interventions tested

Trivalent influenza vaccine (inactivated and fragmented). — full drug profile →

Conditions studied

Human Influenza — all drugs for Human Influenza →

Sponsor

Butantan Institute

Who can join

Adults 18 to 59, any sex, with Human Influenza. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Percentage of Seroconversion.
Time frame: 21 days (+7 days) after vaccination.
Seroconversion will be defined as HI titers ≥1:40 post-vaccination among subjects with pre-vaccination HI titers \<1:10, or as a 4-fold increase in post-vaccination HI titers among subjects with pre -vaccination HI titers ≥ 1:10.
Percentage of Seroprotection
Time frame: 21 days (+7 days) after vaccination.
Seroprotection will be defined as post-vaccinations HI titers ≥1:40.
Increase in the geometric mean titers of HI post-vaccination.
Time frame: 21 days (+7 days) after vaccination.

Sponsor's own description

This will be an open label, parallel, randomized clinical trial that will evaluate the immunogenicity and safety of the trivalent influenza vaccine (inactivated and fragmented) produced by Instituto Butantan among adult kidney transplant recipients, when administered in three vaccination regimens: i) the recommended dose; ii) a single double dose; iii) two doses administered with a 21 day interval. The randomization ratio among the three groups of kidney transplant recipients will be 1:1, and 60 participants will be included in each group. After vaccination all participants will be followed for 26 weeks. In addition, 15 healthy adults will be included as a control group, and will receive the recommended dose. The study hypothesis is that a different vaccination regimen can improve the immune response of kidney transplant recipients after vaccination with the trivalent influenza vaccine (inactivated and fragmented).

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:

Other recruiting trials for Human Influenza

Currently open trials in the same condition.

NCT04487041 — Tfh Dysfunction in HIV and Aging · Phase 4 · 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 NCT02104869 (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: 20 July 2015

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/NCT02104869.

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