Last reviewed · How we verify
NCT01719783
Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Turkey/Turkey/05/133 (H5N2) Influenza Vaccine
Phase 1 trial testing LAIV H5N2 in Influenza in 40 participants. Completed in 1 January 2013.
1 January 2013
Quick facts
| Lead sponsor | PATH |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | prevention |
| Enrollment | 40 |
| Start date | 1 September 2012 |
| Primary completion | 1 January 2013 |
| Estimated completion | 1 January 2013 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- LAIV H5N2 — full drug profile →
- Placebo
Conditions studied
- Influenza — all drugs for Influenza →
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.
-
Adverse Events by Severity
Time frame: 6 days
Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity
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):
-
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT01719783
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Influenza
Currently open trials in the same condition.
- NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
- NCT07496450 — A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults · Phase 3 · recruiting
- NCT07302256 — A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above · Phase 1 · recruiting
- NCT07431840 — Immune Defense Protein Impact On Respiratory Immune Outcomes · NA · recruiting
- NCT07485855 — Influenza Vaccination Strategy for Patients With Hematologic Malignancy · Phase 3 · recruiting
Other PATH trials
Trials by the same sponsor.
- NCT06895486 — Study of Co-administered (Types 1 & 2) Novel Oral Poliomyelitis Vaccines Evaluation · Phase 2 · recruiting
- NCT06129916 — Assessing the Acceptability, Feasibility, Effectiveness and Cost-effectiveness of LADB · not yet recruiting
- NCT06879327 — Infant Malaria Vaccine Schedule Optimization · Phase 2 · recruiting
- NCT06137664 — Study of Trivalent and Bivalent (Types 1 & 2) Novel Oral Poliomyelitis Vaccines · Phase 1, PHASE2 · recruiting
- NCT05758506 — Developing a Screening Tool for Primary Immunodeficiency Disease (PID) in Pakistan · 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 NCT01719783 (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 PATH
- Last refreshed: 26 November 2018
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