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Completed Phase 4 Interventional Accepts healthy volunteers Results available

A Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

ClinicalTrials.gov ID: NCT01579916

Public ClinicalTrials.gov record NCT01579916. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 3:21 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety of 3 New 6:2 Influenza Virus Reassortants in Adults

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This prospective annual release study was designed to assess the safety of a trivalent influenza virus vaccine using two new strains recommended for the 2012-2013 influenza season not previously contained in the trivalent intranasal FluMist vaccine. Three hundred healthy adults will receive a single dose of vaccine or placebo and will be followed for 180 days after study vaccination.

Study identification

NCT ID
NCT01579916
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
MedImmune LLC
Industry
Enrollment
303 participants

Conditions and interventions

Conditions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
18 Years to 49 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 2012 (Type not available)
Primary completion
Nov 2012 (Actual)
Completion
Nov 2012 (Actual)
Last update posted
Feb 3, 2014

2012

United States locations

U.S. sites
3
U.S. states
3
U.S. cities
3
Facility City State ZIP Site status
Research Site Miami Florida 33143 —
Research Site Stockbridge Georgia 30281 —
Research Site Portland Oregon 97239 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01579916, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 3, 2014 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01579916 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →