Healthy Children
Conditions
Interventions
Trade Name: Fluenz Tetra
Product Name: Quadrivalent Live Attenuated Influenza Vaccine
Product Code: MEDI3250
Pharmaceutical Form: Nasal spray
Pharmaceutical form of the placebo: Nasal spray
Route of a
Sponsors
AstraZeneca K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 7 through 18 years of age at the time of randomization. 2. A written informed consent should be obtained from the subject’s legally acceptable representative, and a written informed assent should be obtained from the subject if possible. 3. Available for illness visits at clinic during the influenza surveillance period. 4. Ability of the legal representative to understand and comply with the requirements of the protocol. 5. Parent/guardian available by telephone, email or etc. 6. Females of childbearing potential, unless surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), has sterile male partner, is premenarchal, or practices 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 with spermicide, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of investigational product, and must agree to continue using such precautions for 60 days after the final dose of investigational product. 7. A subject who is considered by the investigator to be at risk of pregnancy must also have a negative urine pregnancy test at screening and, if screening and Day 0 do not occur on the same day, on the day of vaccination prior to randomization. Investigator judgment is required to assess each subject's need for pregnancy testing. 8. Healthy by medical history and physical examination OR presence of stable underlying chronic medical condition for which hospitalization has not been required in the previous year Are the trial subjects under 18? yes Number of subjects for this age range: 1008 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1008 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who were previously administered influenza vaccine in 2014-2015 influenza season 2. Previous randomisation in the present study 3. Participation in another clinical study with an investigational product during the last 3 month 4. Acute illness or evidence of significant active infection at randomization; 5. Fever =99.5°F (37.5°C) at randomization; 6. Any drug therapy from 15 days prior to randomization or expected drug therapy through 28 days post last dose with the exception of the following classes/types of medications, which are allowed: Contraceptives (change in contraceptive type or method is acceptable as long as guidelines are followed for prevention of pregnancy during change); Topical corticosteroids, calcineurin inhibitors, or antifungals for uncomplicated dermatitis; Chronic medications (including those taken on an as-needed basis) that have been well tolerated and were not initiated and/or did not have a dosage change within 90 days prior to randomization. 7. Current or expected receipt of immunosuppressive medications within a 28-day window around any dose, including an immunosuppressive dose of corticosteroids, which is defined as =20 mg/day of prednisone or its equivalent, given daily or on alternate days for =15 days (intranasal, intra-articular, and topical corticosteroids are permitted); Note: topical corticosteroids for uncomplicated dermatitis may be used throughout the study according to the judgment of the investigator; topical calcineurin inhibitors may be used in accordance with their package insert at entry and during study participation. 8. Any known immunosuppressive condition or immune deficiency disease including known or suspected infection with human immunodeficiency virus (HIV); 9. 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; 10. Use of aspirin or salicylate-containing medications within 28 days prior to randomization or expected receipt through the entire study; 11. History of Guillain-Barré syndrome; 12. Use of antiviral agents with activity against influenza virus (including amantadine, rimantadine, oseltamivir, and zanamivir) within 28 days prior to first dose of investigational product or anticipated use of such agents in the study period; 13. Administration of any live virus vaccine within 30 days prior to enrolment, or if receipt of another live virus vaccine is expected within 30 days of any study vaccination; 14. Administration of any inactivated vaccine within 14 days prior to enrolment or if receipt of another inactivated vaccine is expected within 14 days of any study vaccination; 15. Receipt of any blood product within 90 days prior to vaccination or expected receipt during this study; 16. Pregnant or lactating female 17. Involvement in the planning and conduct of the study (applies to all AstraZeneca staff and staff at the study site as a legal representative) 18. Any condition that, in the opinion of the investigator, might interfere with the interpretation or evaluation of the vaccines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy (the incidence of laboratory-confirmed influenza infection caused by any community-acquired wild-type strains matched to the vaccine) of MEDI3250 compared to placebo. To assess the safety and tolerability of MEDI3250 compared to placebo. ;Secondary Objective: To assess the safety and tolerability of MEDI3250 compared to placebo. ;Primary end point(s): The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed symptomatic influenza infection caused by any community-acquired wild-type strains matched to the vaccine, occurring during the influenza surveillance period and at least 14 days after the last required vaccination. For the primary endpoint, laboratory-confirmed symptomatic influenza infection is defined as the presence of modified Centers for Disease Control (CDC)-ILI associated with laboratory-confirmed influenza. Modified CDC-ILI is defined as increased temperature =100°F (37.8°C) oral or equivalent plus the presence of cough, sore throat, or runny nose/nasal congestion occurring on the same or consecutive days. • Solicited symptoms experienced from administration of investigational product through 14 days post vaccination by dose number (as appropriate), • Adverse events experienced from administration of investigational product through 28 days post vaccination by dose number (as appropriate), • Treatment-emergent SAEs experienced from administration of investigational product through 28 days post vaccination by dose number (as appropriate). • Treatment-emergent SAEs experienced from informed consent through the end of the enrolled influenza season. ;Timepoint(s) of evaluation of this end point: The vsaccine efficacy: Through the end of the enrolled influenza season(April 2015) in serious adverse event Safety: 14 days post vaccination by dose number in solicited symptoms 28 days post vaccination by dose number in adverse events 28 days post vaccination by dose number in seri | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed symptomatic influenza infection caused by any community-acquired wild-type strains regardless of match to the vaccine, occurring during the influenza surveillance period and at least 14 days after the last required vaccination. For the secondary endpoint, laboratory-confirmed symptomatic influenza infection is defined as the presence of modified CDC-ILI associated with laboratory-confirmed influenza. Modified CDC-ILI is defined as increased temperature = 100°F (37.8°C) oral or equivalent plus the presence of cough, sore throat, or runny nose/nasal congestion occurring on the same or consecutive days. ;Timepoint(s) of evaluation of this end point: Through the end of the enrolled influenza season(April 2015) in serious adverse event | — |
Countries
Japan
Contacts
Public ContactResearch & Development
AstraZeneca K.K.
Outcome results
None listed