NCT02153671 is a Phase 2 clinical trial of A(H5N1) inactivated influenza vaccine (IIV) in Influenza Vaccine, sponsored by PATH.

Who is sponsoring NCT02153671?

NCT02153671 is sponsored by PATH.

What drugs are being tested in NCT02153671?

Interventions in NCT02153671: A(H5N1) inactivated influenza vaccine (IIV), A(H5N2) live attenuated influenza vaccine (LAIV).

What condition does NCT02153671 study?

NCT02153671 studies Influenza Vaccine.

Is NCT02153671 still recruiting?

NCT02153671 is currently completed. Last updated 14 February 2019.

Are results published for NCT02153671?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-02-14 · How we verify

NCT02153671

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

Immunogenicity of OrniFlu® Inactivated Influenza Vaccine in Subjects Previously Immunized With Live Attenuated H5N2 Influenza Vaccine and in Non-vaccinated Subjects

Completed Phase 2 Results posted Last updated 14 February 2019

What this trial tests

Phase 2 trial testing A(H5N1) inactivated influenza vaccine (IIV) in Influenza Vaccine in 43 participants. Completed in 1 September 2014.

Timeline

1 May 2014

Primary endpoint
1 September 2014

1 September 2014

Quick facts

Lead sponsor	PATH
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	43
Start date	1 May 2014
Primary completion	1 September 2014
Estimated completion	1 September 2014
Sites	1 location across Russia

Drugs / interventions tested

A(H5N1) inactivated influenza vaccine (IIV) — full drug profile →
A(H5N2) live attenuated influenza vaccine (LAIV) — full drug profile →

Conditions studied

Influenza Vaccine — all drugs for Influenza Vaccine →

Sponsor

PATH — full company profile →

Who can join

Adults 18 to 51, any sex, with Influenza Vaccine. Healthy volunteers can join.

What's being measured

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

Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Duck/Potsdam/86/92 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Time frame: 56 days
The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Time frame: 56 days
The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Time frame: 56 days
The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with
Geometric Mean Titer of Serum Hemagglutination Inhibition Antibody Response to A/Turkey/Turkey/5/05(H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Time frame: 56 days
The following H5 antigens were tested to evaluate the breadth of the response: i) A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)); ii) A/turkey/Turkey/5/05(H5N1) PR8-based candidate vaccine virus (NIBRG-23 (H5N1)); iii) A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1)); and iv) A/17/duck/Potsdam/86/92 (H5N2) (d/Pot (H5N2)). HAI tests were performed on serum samples with
Geometric Mean Titer of Microneutralization Antibody Response to A/17/Turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV Strain Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Time frame: 56 days
Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the
Geometric Mean Titer of Microneutralization Antibody Response to A/Indonesia/5/2005 (H5N1) PR8-based Candidate Vaccine Virus Following Administration of A(H5N1) Inactivated Influenza Vaccine (IIV)
Time frame: 56 days
Serum specimens were tested for neutralizing antibodies against A/17/turkey/Turkey/05/133 (H5N2) (17/t/Tur (H5N2)) LAIV strain and A/Indonesia/5/2005 (H5N1) PR8-based candidate vaccine virus (Indo (H5N1) by MN using Madin-Darby Canine Kidney cells. Titers of neutralizing antibodies were expressed as reciprocal of the greatest dilution giving a neutralization of 50% on the cytopathic effects of the

Sponsor's own description

This study is designed to assess whether a live attenuated Influenza vaccine (LAIV) can induce a long-lasting immune memory by comparing the immunologic response to two doses of the OrniFlu® inactivated vaccine given to subjects previously primed with LAIV and subjects who did not received LAIV.

Publications & conference data

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

Assessment of immune responses to H5N1 inactivated influenza vaccine among individuals previously primed with H5N2 live attenuated influenza vaccine.
Rudenko L, Naykhin A, Donina S, Korenkov D, et al · · 2015 · cited 21× · PMID 26697973 · DOI 10.1080/21645515.2015.1069931
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 Vaccine

Currently open trials in the same condition.

NCT07421037 — Clinical Trial of Quadrivalent Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older · Phase 1 · active not recruiting
NCT07421050 — Clinical Trial of Subunit Influenza Vaccine (Adjuvant) in Chinese Population Aged 65 Years and Older · Phase 1 · active not recruiting
NCT05518500 — A Deep Longitudinal Analysis of Next Generation Influenza Vaccines in Older Adults · Phase 4 · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02153671 (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: 14 February 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/NCT02153671.

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