NCT01982331 is a Phase 1 clinical trial of LAIV H2N2 in Influenza, sponsored by PATH.

Who is sponsoring NCT01982331?

NCT01982331 is sponsored by PATH.

What drugs are being tested in NCT01982331?

Interventions in NCT01982331: LAIV H2N2, Placebo.

Is NCT01982331 still recruiting?

NCT01982331 is currently completed. Last updated 6 February 2019.

Are results published for NCT01982331?

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

Last reviewed 2019-02-06 · How we verify

NCT01982331

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

Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/California/66/395 (H2N2)Influenza Vaccine

Completed Phase 1 Results posted Last updated 6 February 2019

What this trial tests

Phase 1 trial testing LAIV H2N2 in Influenza in 38 participants. Completed in 1 March 2014.

Timeline

1 October 2013

Primary endpoint
1 January 2014

1 March 2014

Quick facts

Lead sponsor	PATH
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	38
Start date	1 October 2013
Primary completion	1 January 2014
Estimated completion	1 March 2014
Sites	1 location across Russia

Drugs / interventions tested

LAIV H2N2 — full drug profile →
Placebo

Conditions studied

Influenza — all drugs for Influenza →

Sponsor

PATH — full company profile →

Who can join

Adults 18 to 40, 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.

Percentage of Participants With Immediate Reactions
Time frame: 2 hours
Measured as observed by study staff or reported by the subject to study staff whether related or not related.
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 1
Time frame: 7 days
Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throa
Percentage of Subjects With Solicited Local and Systemic Reactions After Vaccination 2
Time frame: 7 days
Adverse events commonly associated with intranasal vaccination occurring greater than two hours after administration of any dose of study vaccine or placebo through 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. Solicited local reactions included: dryness of the nose, nose bleeds, ticklish nose, nasal congestion, runny nose, ticklish throa
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 1
Time frame: 7 days following each vaccination
All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.
Percentage of Subjects With Unsolicited Adverse Events After Vaccination 2
Time frame: 7 days following each vaccination
All other adverse events (including unsolicited events and abnormal laboratory parameters) occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff.

Sponsor's own description

This is a phase I study to evaluate the safety of a vaccine to protect against influenza viruses of the H2N2 subtype. A total of 40 adults will be enrolled and receive two doses of vaccine or placebo one month apart.

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 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01982331 (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 PATH
Last refreshed: 6 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/NCT01982331.

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