A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age - MI-CP185

Study identifier:MI-CP185

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Active Controlled Study to Evaluate the Immunogenicity of MEDI3250 in Adults 18 to 49 Years of Age

Medical condition

healthy or stable underlying chronic medical condition

Phase

Phase 2/3

Healthy volunteers

Yes

Study drug

Sex

All

Actual Enrollment

1800

Study type

Interventional

Age

18 Years - 49 Years

Date

Study Start Date: 01 Mar 2009

Primary Completion Date: 01 May 2009

Study Completion Date: 01 Oct 2009

Study design

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention

Verification:

Verified 01 Nov 2011 by MedImmune, LLC

Collaborators

Inclusion and exclusion 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

No locations available

Arms	Assigned Interventions
Experimental: 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]).	Biological/Vaccine: Q/LAIV (MEDI3250) 0.2 mL dose at Day 0 Other Name: MEDI3250
Active Comparator: 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.	Biological/Vaccine: FluMist/B/Yamagata 0.2 mL dose at Day 0 Other Name: FluMist
Active Comparator: 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.	Biological/Vaccine: FluMist/B/Victoria 0.2 mL dose at Day 0 Other Name: FluMist

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Trial Results Summaries
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Contacts

Contact

Therese Takas

301-398-0000

[email protected]

Investigators

Principal Investigator

Judith Falloon

MedImmune LLC