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

NCT01579916 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2014-02-03

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

Trivalent Influenza Virus Vaccine

Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10\^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.

OTHER

Placebo

Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Raburn Mallory, MD · MedImmune LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01579916 on ClinicalTrials.gov