A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age

NCT ID: NCT00860067

Last Updated: 2011-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 1800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2009-10-31

Brief Summary

The objective of this study was to show that quadrivalent live attenuated influenza vaccine (Q/LAIV; MEDI3250) produced antibody levels similar to those produced by the commercial vaccine, FluMist.

Detailed Description

This randomized, double-blind, active controlled, multicenter study enrolled 1,800 subjects who were 18 to 49 years of age. Subjects were randomized by site in a 4:1:1 fashion to receive a single dose of Q/LAIV, trivalent FluMist containing an influenza B strain from the Yamagata lineage (FluMist/B/Yamagata), or trivalent FluMist containing an influenza B strain from the Victoria lineage (FluMist/B/Victoria). The study was conducted at multiple sites in the USA in the influenza off-season.

Conditions

Healthy or Stable Underlying Chronic Medical Condition

Keywords

influenza, FluMist, adults, vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Q/LAIV (MEDI3250)

Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature-sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 \[A/South Dakota/6/2007\], A/H3N2 \[A/Uruguay/716/2007\], B/Victoria \[B/Malaysia/2506/2004\], and B/Yamagata \[B/Florida/4/2006\]).

Group Type: EXPERIMENTAL

Q/LAIV (MEDI3250)

Intervention Type: BIOLOGICAL

0.2 mL dose at Day 0

FluMist/B/Yamagata

FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature-sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 \[A/South Dakota/6/2007\], A/H3N2 \[A/Uruguay/716/2007\], and B/Yamagata \[B/Florida/4/2006\])a B strain of the Yamagata lineage.

Group Type: ACTIVE_COMPARATOR

FluMist/B/Yamagata

Intervention Type: BIOLOGICAL

0.2 mL dose at Day 0

FluMist/B/Victoria

FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10\^7.0 ± 0.5 FFU of each of 3 temperature-sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 \[A/South Dakota/6/2007\], A/H3N2 \[A/Uruguay/716/2007\], and B/Victoria \[B/Malaysia/2506/2004\])a B strain of the Victoria lineage.

Group Type: ACTIVE_COMPARATOR

FluMist/B/Victoria

Intervention Type: BIOLOGICAL

0.2 mL dose at Day 0

Interventions

Q/LAIV (MEDI3250)

0.2 mL dose at Day 0

Intervention Type: BIOLOGICAL

FluMist/B/Yamagata

0.2 mL dose at Day 0

Intervention Type: BIOLOGICAL

FluMist/B/Victoria

0.2 mL dose at Day 0

Intervention Type: BIOLOGICAL

Other Intervention Names

MEDI3250; FluMist; FluMist

Eligibility Criteria

Inclusion Criteria

• Male or female age 18 to 49 years, inclusive, on the day of randomization (reached his or her eighteenth year birthday but not yet reached his or her 50th year birthday) at the time of the dose of blinded investigational product
• Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluations
• Females of child-bearing potential, (ie, unless surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], had a sterile male partner, was at least 1 year post-menopausal, or practiced abstinence) must have used an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of investigational product, and must have agreed to continue using such precautions for 60 days after the dose of investigational product. In addition, the subject must also have had a negative urine or blood pregnancy test at screening and, if screening and Day 0 did not occur on the same day, on the day of vaccination prior to randomization. Investigator judgment was required to assess a female subject's capability of pregnancy.
• Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization was not required in the previous year
• Able to complete follow-up period of 180 days post dose of vaccine as required by the protocol
• Subject available by telephone
• Able to understand and comply with the requirements of the protocol, as judged by the investigator

Exclusion Criteria

• Acute illness or evidence of significant active infection at randomization
• Fever ≥ 100.4°F (38°C) at randomization
• History of asthma
• Any drug therapy from 15 days prior to randomization or expected drug therapy through 30 days post dose with the exception of contraceptives or chronic medications that were well tolerated and were not initiated and/or did not have a dosage change within 90 days of randomization.
• Previous medical history or evidence of an intercurrent illness that might have compromised the safety of the subject in the study
• Current or expected receipt of immunosuppressive medications (inhaled and topical corticosteroids were permitted) including corticosteroids (≥ 20 mg/day of prednisone equivalent given daily or on alternate days for ≥ 14 days) within a 30-day window around dose of investigational product Note: topical corticosteroids for uncomplicated dermatitis were permitted according to the judgment of the investigator; topical calcineurin inhibitors were permitted in accordance with their package insert at entry and during study participation.
• Receipt of immunoglobulin or blood products within 90 days before randomization into the study or expected receipt during study participation
• Receipt of any investigational drug therapy or standard vaccine within 30 days before the dose of investigational product in this study through 30 days after the dose of investigational product (use of licensed agents for indications not listed in the package insert was permitted)
• Any known immunosuppressive condition or immune deficiency disease including known or suspected infection with human immunodeficiency virus (HIV)
• History of allergic disease or reactions likely to be exacerbated by any component of the investigational product including allergy to eggs, egg proteins, gentamicin, or gelatin; or serious, life threatening, or severe reactions to previous influenza vaccinations
• History of Guillain-Barré syndrome
• Use of antiviral agents with activity against influenza virus (including amantadine, rimantadine, oseltamivir and zanamivir) within 30 days prior to dose of investigational product or anticipated use within 30 days after vaccination
• Known or suspected mitochondrial encephalomyopathy
• Lactating woman
• History of alcohol or drug abuse that, in the opinion of the investigator, would have affected the subject's safety or compliance with study
• Any condition that, in the opinion of the investigator, would have interfered with evaluation of the investigational product or interpretation of subject safety or study results
• Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

MedImmune, LLC an affiliate of AstraZeneca AB

Principal Investigators

Judith Falloon, M.D.

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Benchmark Research

Sacramento, California, United States

California Research Foundation

San Diego, California, United States

Benchmark Research

San Francisco, California, United States

University Clinical Research-Deland, LLC

DeLand, Florida, United States

Pharmax Research Clinic, Inc

Miami, Florida, United States

University Clinical Research, Inc

Pembroke Pines, Florida, United States

Miami Research Associates

South Miami, Florida, United States

Clinical Research Atlanta

Stockbridge, Georgia, United States

Vince and Associates Clinical Research

Overland Park, Kansas, United States

Kentucky Pediatric / Adult Research

Bardstown, Kentucky, United States

The Center for Pharmaceutical Research, PC

Kansas City, Missouri, United States

Sundance Clinical Research

St Louis, Missouri, United States

Meridian Clinical Research, LLC

Omaha, Nebraska, United States

Rochester Clinical Research, Inc.

Rochester, New York, United States

Clinical Research Associates, Inc

Nashville, Tennessee, United States

Benchmark Research

Austin, Texas, United States

Benchmark Research

Fort Worth, Texas, United States

Advanced Clinical Research

West Jordan, Utah, United States

Countries

United States

References

Block SL, Yi T, Sheldon E, Dubovsky F, Falloon J. A randomized, double-blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults. Vaccine. 2011 Nov 21;29(50):9391-7. doi: 10.1016/j.vaccine.2011.09.109. Epub 2011 Oct 6.

Reference Type: BACKGROUND

PMID: 21983154 (View on PubMed)

Other Identifiers

MI-CP185

Identifier Type: -

Identifier Source: org_study_id