A Study to Evaluate the Immunogenicity of Quadrivalent LAIV in Adults 18 to 49 Years of Age (MI-CP185)
30 novembre 2011 aggiornato da: MedImmune LLC
A Randomized, Double-Blind, Active Controlled Study to Evaluate the Immunogenicity of MEDI3250 in Adults 18 to 49 Years of Age
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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1800
Fase
- Fase 2
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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California
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Sacramento, California, Stati Uniti, 95816
- Benchmark Research
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San Diego, California, Stati Uniti, 92103-6204
- California Research Foundation
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San Francisco, California, Stati Uniti, 94102
- Benchmark Research
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Florida
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Deland, Florida, Stati Uniti, 32720
- University Clinical Research-Deland, LLC
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Miami, Florida, Stati Uniti, 33126
- Pharmax Research Clinic, Inc
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Pembroke Pines, Florida, Stati Uniti, 33024
- University Clinical Research, Inc
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South Miami, Florida, Stati Uniti, 33143
- Miami Research Associates
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Georgia
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Stockbridge, Georgia, Stati Uniti, 32801
- Clinical Research Atlanta
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Kansas
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Overland Park, Kansas, Stati Uniti, 66212
- Vince and Associates Clinical Research
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Kentucky
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Bardstown, Kentucky, Stati Uniti, 40004
- Kentucky Pediatric / Adult Research
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Missouri
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Kansas City, Missouri, Stati Uniti, 64114
- The Center for Pharmaceutical Research, PC
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St. Louis, Missouri, Stati Uniti, 63141
- Sundance Clinical Research
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Nebraska
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Omaha, Nebraska, Stati Uniti, 68314
- Meridian Clinical Research, LLC
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New York
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Rochester, New York, Stati Uniti, 14609
- Rochester Clinical Research, Inc.
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37201
- Clinical Research Associates, Inc
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Texas
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Austin, Texas, Stati Uniti, 78705
- Benchmark Research
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Ft. Worth, Texas, Stati Uniti, 76135
- Benchmark Research
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Utah
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West Jordan, Utah, Stati Uniti, 84088
- Advanced Clinical Research
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 49 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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]).
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0.2 mL dose at Day 0
Altri nomi:
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Comparatore attivo: 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.
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0.2 mL dose at Day 0
Altri nomi:
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Comparatore attivo: 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.
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0.2 mL dose at Day 0
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The 4 Post-dose Strain-specific Serum Hemagglutination Inhibition (HAI) Antibody Geometric Mean Titers (GMT) in the Q/LAIV (MEDI3250) Arm Are Noninferior to Those in the Comparator FluMist Group.
Lasso di tempo: Day 28-35
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Noninferior immune response was defined as having the upper bound of the 2-sided 95% confidence intervals (CIs) for the HAI antibody GMT ratio (FluMist comparator divided by Q/LAIV) ≤ 1.5 for each of the 4 strains.
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Day 28-35
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Experience Strain-specific Seroresponse Post Dose.
Lasso di tempo: Day 0 and Day 28-35
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Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
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Day 0 and Day 28-35
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The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.
Lasso di tempo: Day 0 and Day 28-35
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Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.
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Day 0 and Day 28-35
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The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.
Lasso di tempo: Day 0 and Day 28-35
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Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.
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Day 0 and Day 28-35
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The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.
Lasso di tempo: Day 0 and Day 28-35
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Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.
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Day 0 and Day 28-35
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The Number of Serosusceptible Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.
Lasso di tempo: Day 0 and Day 28-35
|
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Participants with a baseline HAI titer <= 8 were considered to be serosusceptible for that strain.
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Day 0 and Day 28-35
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The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H1N1 Strain-specific Seroresponse Post Dose.
Lasso di tempo: Day 0 and Day 28-35
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Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
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Day 0 and Day 28-35
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The Number of Seropositive Participants Within Each Treatment Arm Who Experience A/H3N2 Strain-specific Seroresponse Post Dose.
Lasso di tempo: Day 0 and Day 28-35
|
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
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Day 0 and Day 28-35
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The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Yamagata Strain-specific Seroresponse Post Dose.
Lasso di tempo: Day 0 and Day 28-35
|
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
|
Day 0 and Day 28-35
|
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The Number of Seropositive Participants Within Each Treatment Arm Who Experience B/Victoria Strain-specific Seroresponse Post Dose.
Lasso di tempo: Day 0 and Day 28-35
|
Seroresponse was defined as a ≥ 4-fold rise in HAI titer from baseline.
Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
|
Day 0 and Day 28-35
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The Number of Participants (Regardless of Serostatus) Within Each Treatment Arm Who Achieved a Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Lasso di tempo: Day 28-35
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Day 28-35
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The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Lasso di tempo: Day 28-35
|
Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.
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Day 28-35
|
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The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Lasso di tempo: Day 28-35
|
Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.
|
Day 28-35
|
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The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Lasso di tempo: Day 28-35
|
Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.
|
Day 28-35
|
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The Number of Serosusceptible Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Lasso di tempo: Day 28-35
|
Participants with a strain-specific baseline HAI titer ≤ 8 were considered to be serosusceptible to that strain.
|
Day 28-35
|
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The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H1N1 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Lasso di tempo: Day 28-35
|
Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
|
Day 28-35
|
|
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a A/H3N2 Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Lasso di tempo: Day 28-35
|
Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
|
Day 28-35
|
|
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Yamagata Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Lasso di tempo: Day 28-35
|
Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
|
Day 28-35
|
|
The Number of Seropositive Participants Within Each Treatment Arm Who Achieved a B/Victoria Strain-specific HAI Antibody Titer ≥ 32 Post Dose.
Lasso di tempo: Day 28-35
|
Participants with a baseline HAI titer > 8 were considered to be seropositive for that strain.
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Day 28-35
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The Number of Participants Experiencing Each Solicited Symptom From Administration of Investigational Product Through 14 Days Post Vaccination
Lasso di tempo: Days 0-14
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Solicited symptoms were fever ≥ 100.4°F (38.0°C), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) OR tiredness/weakness, decreased appetite.
Collection of specific solicited symptoms (sore throat, headache, generalized muscle aches) was omitted when, according to the judgment of the investigator, the subject was too young to reliably report a particular symptom.
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Days 0-14
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The Number of Participants Reporting Any Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination
Lasso di tempo: Days 0-28 post vaccination
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Any untoward medical occurrence in a patient or clinical investigation in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
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Days 0-28 post vaccination
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Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 28 Days Post Vaccination
Lasso di tempo: Days 0-28 post vaccination
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Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
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Days 0-28 post vaccination
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Number of Participants Reporting Any Serious Adverse Event From Administration of Investigational Product Through 180 Days Post Vaccination
Lasso di tempo: Days 0-180 post vaccination
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Serious adverse events were those that resulted in death; were life-threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a birth defect in the offspring of a study participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization but that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above.
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Days 0-180 post vaccination
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Number of Participants Reporting New Onset Chronic Diseases From Administration of Investigational Product Through 180 Days Post Vaccination
Lasso di tempo: Days 0-180 post vaccination
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An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant.
|
Days 0-180 post vaccination
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Judith Falloon, M.D., MedImmune LLC
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 marzo 2009
Completamento primario (Effettivo)
1 maggio 2009
Completamento dello studio (Effettivo)
1 ottobre 2009
Date di iscrizione allo studio
Primo inviato
9 marzo 2009
Primo inviato che soddisfa i criteri di controllo qualità
9 marzo 2009
Primo Inserito (Stima)
11 marzo 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
5 dicembre 2011
Ultimo aggiornamento inviato che soddisfa i criteri QC
30 novembre 2011
Ultimo verificato
1 novembre 2011
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- MI-CP185
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .