Last reviewed · How we verify

NCT01719783

Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Turkey/Turkey/05/133 (H5N2) Influenza Vaccine

Completed Phase 1 Results posted Last updated 26 November 2018
What this trial tests

Phase 1 trial testing LAIV H5N2 in Influenza in 40 participants. Completed in 1 January 2013.

Timeline
1 September 2012
Primary endpoint
1 January 2013
1 January 2013

Quick facts

Lead sponsorPATH
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment40
Start date1 September 2012
Primary completion1 January 2013
Estimated completion1 January 2013
Sites1 location across Russia

Drugs / interventions tested

Conditions studied

Sponsor

PATH — full company profile →

Who can join

Adults 18 to 49, any sex, with Influenza. Healthy volunteers can join.

What's being measured

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

Sponsor's own description

To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133 (H5N2) in healthy adults.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cross-Reactivity of SARS-CoV-2 Nucleocapsid-Binding Antibodies and Its Implication for COVID-19 Serology Tests.
    Rak A, Donina S, Zabrodskaya Y, Rudenko L, et al · · 2022 · cited 27× · PMID 36146847 · DOI 10.3390/v14092041
  2. Clinical testing of pre-pandemic live attenuated A/H5N2 influenza candidate vaccine in adult volunteers: results from a placebo-controlled, randomized double-blind phase I study.
    Rudenko L, Kiseleva I, Stukova M, Erofeeva M, et al · · 2015 · cited 21× · PMID 26296497 · DOI 10.1016/j.vaccine.2015.08.019
  3. A Phase 1 Randomized Placebo-Controlled Study to Assess the Safety, Immunogenicity and Genetic Stability of a New Potential Pandemic H7N9 Live Attenuated Influenza Vaccine in Healthy Adults.
    Kiseleva I, Isakova-Sivak I, Stukova M, Erofeeva M, et al · · 2020 · cited 7× · PMID 32532097 · DOI 10.3390/vaccines8020296
  4. Genetic stability of live attenuated vaccines against potentially pandemic influenza viruses.
    Kiseleva I, Dubrovina I, Fedorova E, Larionova N, et al · · 2015 · cited 5× · PMID 26432909 · DOI 10.1016/j.vaccine.2015.09.050
  5. A novel immunofluorescent test system for SARS-CoV-2 detection in infected cells.
    Rak A, Matyushenko V, Prokopenko P, Kostromitina A, et al · · 2024 · cited 3× · PMID 38820303 · DOI 10.1371/journal.pone.0304534
  6. RDE Treatment Prevents Non-Specific Detection of SARS-CoV-2- and Influenza-Specific IgG Antibodies in Heat-Inactivated Serum Samples.
    Goshina A, Matyushenko V, Mezhenskaya D, Rak A, et al · · 2023 · PMID 37366655 · DOI 10.3390/antib12020039

Verify or expand the search:

Other recruiting trials for Influenza

Currently open trials in the same condition.

Other PATH trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT01719783.

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