NCT01104493 is a Phase 4 clinical trial of Monovalent Frozen FluMist® in Healthy, sponsored by MedImmune LLC.

Who is sponsoring NCT01104493?

NCT01104493 is sponsored by MedImmune LLC.

What drugs are being tested in NCT01104493?

Interventions in NCT01104493: Monovalent Frozen FluMist®, Placebo.

Is NCT01104493 still recruiting?

NCT01104493 is currently completed. Last updated 14 July 2011.

Are results published for NCT01104493?

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

Last reviewed 2011-07-14 · How we verify

NCT01104493

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

A Prospective, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety of a New 6:2 Influenza Virus Reassortant

Completed Phase 4 Results posted Last updated 14 July 2011

What this trial tests

Phase 4 trial testing Monovalent Frozen FluMist® in Healthy in 300 participants. Completed in 1 December 2010.

Timeline

1 May 2010

Primary endpoint
1 June 2010

1 December 2010

Quick facts

Lead sponsor	MedImmune LLC
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	300
Start date	1 May 2010
Primary completion	1 June 2010
Estimated completion	1 December 2010
Sites	3 locations across United States

Drugs / interventions tested

Monovalent Frozen FluMist® — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

MedImmune LLC — full company profile →

Who can join

Adults 18 to 49, any sex, with Healthy. 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 Reporting Fever, Defined as Oral Temperature ≥ 101°F
Time frame: Study Days 1-8
A comparison of the rate of fever (oral temperature ≥ 101°F) reported during the 7 days post administration of investigational product between the monovalent vaccine and placebo groups.

Sponsor's own description

To assess the safety of a new influenza virus vaccine containing a new virus strain in healthy patients prior to the release of the vaccine.

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:

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Other MedImmune LLC trials

Trials by the same sponsor.

NCT04145193 — Novel Oncology Therapies in Combination With Adjuvant Chemo in High-risk MSS-CRC · Phase 2 · withdrawn
NCT04522323 — A Study to Evaluate MEDI5752 and Axitinib in Subjects With Advanced Renal Cell Carcinoma · Phase 1 · active not recruiting
NCT03903718 — Evaluation of the Safety and Efficacy of a Monoclonal Antibody to Treat Influenza · Phase 2 · withdrawn
NCT04261075 — IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors. · Phase 1 · completed
NCT03889275 — A Study of MEDI5395 in Combination With Durvalumab in Participants With Select Advanced Solid Tumors · Phase 1 · 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 NCT01104493 (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 MedImmune LLC
Last refreshed: 14 July 2011

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/NCT01104493.

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