NCT01443663 is a Phase 1 clinical trial of H5N1 Vaccine in H5N1 Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT01443663?

NCT01443663 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT01443663?

Interventions in NCT01443663: H5N1 Vaccine.

What condition does NCT01443663 study?

NCT01443663 studies H5N1 Influenza.

Is NCT01443663 still recruiting?

NCT01443663 is currently completed. Last updated 5 February 2016.

Last reviewed 2016-02-05 · How we verify

NCT01443663

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

Immunogenicity and Safety Study of a 45 Micrograms Dose of Inactivated, Unadjuvanted H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H5N1 and H7N3 Influenza Vaccines and in H5 and Live Attenuated Vaccine Naïve Individuals

Completed Phase 1 Last updated 5 February 2016

What this trial tests

Phase 1 trial testing H5N1 Vaccine in H5N1 Influenza in 69 participants. Completed in 1 March 2013.

Timeline

1 October 2011

Primary endpoint
1 September 2012

1 March 2013

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	69
Start date	1 October 2011
Primary completion	1 September 2012
Estimated completion	1 March 2013
Sites	1 location across United States

Drugs / interventions tested

H5N1 Vaccine — full drug profile →

Conditions studied

H5N1 Influenza — all drugs for H5N1 Influenza →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 22 to 54, any sex, with H5N1 Influenza. Healthy volunteers can join.

What's being measured

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

Characterize the kinetics and magnitude of the antibody response (measured by hemagglutination inhibition assay [HI] and microneutralization assay [MN]) to a single 45 micrograms dose of H5N1 vaccine
Time frame: Measured through the 6 months following participants' last vaccination

Sponsor's own description

H5N1 is an influenza virus that has the potential to cause an influenza pandemic. This study will evaluate the safety and immune response to an H5N1 influenza vaccine in people who have previously received one of two versions of an H5N1 vaccine or have previously received an H7N3 vaccine and in people who have not previously received any live attenuated influenza vaccine (LAIV).

Publications & conference data

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

Intranasal Live Influenza Vaccine Priming Elicits Localized B Cell Responses in Mediastinal Lymph Nodes.
Jegaskanda S, Mason RD, Andrews SF, Wheatley AK, et al · · 2018 · cited 30× · PMID 29444938 · DOI 10.1128/jvi.01970-17
Talaat et al (J Infect Dis 2014; 209:1860–9)
· 2014

Verify or expand the search:

Other recruiting trials for H5N1 Influenza

Currently open trials in the same condition.

NCT07275060 — Immunogenicity and Safety of 2 Doses of Avian Influenza A (H5N1) Vaccine Administered 3 vs. 8 Weeks Apart · Phase 4 · active not recruiting

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Trials by the same sponsor.

NCT07216794 — Small Trial of Alendronate Impact on the Reservoir of HIV · Phase 2 · not yet recruiting
NCT07215858 — BPL-1357 Against H1N1 Influenza Virus Challenge · Phase 2 · recruiting
NCT06987318 — A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) · Phase 1 · not yet recruiting
NCT07124559 — A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of · Phase 1, PHASE2 · not yet recruiting
NCT07342491 — Dasatinib for HIV-1 Reservoir Reduction · Phase 1 · not yet recruiting

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 NCT01443663 (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 National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 5 February 2016

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/NCT01443663.

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