Clinical trial NCT02269475: A Phase3 Study to Evaluate the Efficacy and Safety of MEDI3250 in Healthy Japanese Children Age 7 Years Through 18 Years
Official title: A Phase 3 Randomized, Double-blind Study to Evaluate the Efficacy and Safety of MEDI3250 Compared to Placebo in Healthy Japanese Children Age 7 Years Through 18 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy Japanese Children Age 7 Years Through 18 Years
Keywords: Efficacy
Safety
Tolerability
MEDI3250
Japanese children
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2014-10-21
Enrollment: 1369
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is designed to gather the efficacy, safety and tolerability data in Japanese children 7 to 18 years of age that would support approval of MEDI3250 in Japan.

Detailed description: This randomized, double-blind, placebo controlled, multicenter study will enrol 1008 subjects. The study is designed to gather the efficacy, safety and tolerability data in Japanese children 7 through 18 years of age that would support approval of MEDI3250 in Japan.

For children age 7 years through 18 years, the recommended dosage schedule for intranasal administration is 0.2 mL (0.1 mL per nostril). For children age 7 years through 8 years not previously vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.

For the efficacy endpoint, data will be gathered on the incidence of laboratory-confirmed influenza-like illness in the two treatment arms. Laboratory-confirmed influenza-like illness would include cases of influenza diagnosed using culture-confirmation and/or PCR-based methods.

For the safety and tolerability endpoint, data will be gathered on solicited symptoms, AEs and SAEs.

Subject will be randomized 2:1 to receive MEDI3250 or placebo.

Eligibility 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.

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.

Primary outcomes:
measure: the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain)
timeFrame: through the end of the influenza surveillance period, up to end Apr (6 months)
Secondary outcomes:
measure: the Incidence of Laboratory-confirmed Influenza Infection (Any Strain)
timeFrame: through the end of the influenza surveillance period, up to end Apr (6 months)
measure: the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain)
timeFrame: through the end of the influenza surveillance period, up to end Apr (6 months)
Other outcomes:
Locations:
city: Akashi-shi
country: Japan
facility: Research Site
city: Chofu-shi
country: Japan
facility: Research Site
city: Fuchu-shi
country: Japan
facility: Research Site
city: Fujimi-shi
country: Japan
facility: Research Site
city: Fukui-shi
country: Japan
facility: Research Site
city: Fukuoka-shi
country: Japan
facility: Research Site
city: Fukuroi-shi
country: Japan
facility: Research Site
city: Funabashi-shi
country: Japan
facility: Research Site
city: Gifu-shi
country: Japan
facility: Research Site
city: Hatsukaichi-shi
country: Japan
facility: Research Site
city: Hiroshima-shi
country: Japan
facility: Research Site
city: Ichikawa-shi
country: Japan
facility: Research Site
city: Isumi-shi
country: Japan
facility: Research Site
city: Iwate-gun
country: Japan
facility: Research Site
city: Katsushika-ku
country: Japan
facility: Research Site
city: Kawasaki-shi
country: Japan
facility: Research Site
city: Kisarazu-shi
country: Japan
facility: Research Site
city: Kiyose-shi
country: Japan
facility: Research Site
city: Kobe-shi
country: Japan
facility: Research Site
city: Koga-shi
country: Japan
facility: Research Site
city: Kumamoto-shi
country: Japan
facility: Research Site
city: Kunitachi-shi
country: Japan
facility: Research Site
city: Kuwana-shi
country: Japan
facility: Research Site
city: Matsudo-shi
country: Japan
facility: Research Site
city: Minato-ku
country: Japan
facility: Research Site
city: Morioka-shi
country: Japan
facility: Research Site
city: Nakano-ku
country: Japan
facility: Research Site
city: Okayama-shi
country: Japan
facility: Research Site
city: Ota-ku
country: Japan
facility: Research Site
city: Sapporo-shi
country: Japan
facility: Research Site
city: Sendai-shi
country: Japan
facility: Research Site
city: Setagaya-ku
country: Japan
facility: Research Site
city: Shinjuku-ku
country: Japan
facility: Research Site
city: Shizuoka-shi
country: Japan
facility: Research Site
city: Taito-ku
country: Japan
facility: Research Site
city: Toshima-ku
country: Japan
facility: Research Site
city: Tsu-shi
country: Japan
facility: Research Site
city: Yokkaichi-shi
country: Japan
facility: Research Site
Study officials:
affiliation: Yokohama clinic
name: Masaki Yokohama, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yamaguchi Clinic
name: Toshiko Yamaguchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maeta Pediatrics Clinic
name: Haruo Maeta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HIGASHIKATSUYAMA nakazawa Naika allergy Internal Medicine
name: Hideki Nakazawa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shibasaki internal medicine & Pediatrics Clinic
name: Atsushi Shibasaki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Igarashi Children's Clinic
name: Yutaka Igarashi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Eiju General Hospital
name: Keiko Mitamura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyouai Clinic
name: Satoshi Yamada, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Niwa Family Clinic
name: Kiyoshi Niwa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kanagawa HImawari Clinic
name: Ryuta Ono, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fukuiken Saiseikai Hospital
name: Eiji Kato, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Takahashi Clinic
name: Toshikazu Takahashi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yoshimura Children's Clinic
name: Ryouta Yoshimura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Taniguchi Pediatrics Clinic
name: Hiroshi Taniguchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shinohara Pediatrics Clinic
name: Hidehisa Shinohara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tanabe Pediatrics Clinic
name: Michiko Tanabe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sotobo Children's Clinic
name: Haruo Kuroki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunrise Children's Clinic
name: Hirokazu Sato, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yamada Clinic
name: Katsumi Yamada, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sakiyama Pediatric Clinic
name: Hiroshi Sakiyama, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Okawa Children & Family Clinic
name: Hiroji Okawa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ito ENT Clinic
name: Junichi Ito, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MORIMOTO ENT CLINIC
name: Masato Morimoto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Umemoto Pediatric Clinic
name: Masakazu Umemoto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Matsuda Pediatrics Clinic
name: Tadashi Matuda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aquair Medical Station
name: Sadayoshi Torigoe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Momotaro Clinic
name: Shigeru Mori, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fujimaki Ent Clinic
name: Yutaka Fujimaki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kato Ear Nose Throat Clinic
name: Masaki Kato, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sekino Hospital
name: Hisakuni Sekino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yoga Allergy Clinic
name: Toshikazu Nagakura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ogiwara Ent Clinic
name: Ichiro Ogiwara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical corporation Seisyuukai Funato Clinic
name: Akitoshi Funato, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical corporation Ryoshukai Kanauchi Medical Clinic
name: Naohisa Hoshino, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Social medical corporation IHL ShinagawaEastOne Medical Clinic
name: Munechika Noguchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shinkoiwa Ekimae Sougou Clinic
name: Chiaki Noguchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yukisada Clinic for internal disease
name: Kimihiko Yukisada, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical corporation Junyokai Musashino General Clinic
name: Hiroshi Shimomura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nemoto-geka-seikeigeka
name: Mitsuhiro Nemoto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kawai Naika Iin
name: Naoki Kawai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yajima Children's Clinic
name: Shigehiro Yazima, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Midorino Clinic
name: Tetsuhiko Nagao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tenjin Sogo Clinic
name: Kenjiro Nakamura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kobori Building Clinic
name: Wataru Ikematsu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kimura Shiro Clinic
name: Shiro Kimura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ueda Naika Clinic
name: Mieko Ueda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iwaya Children's Clinic
name: Minako Iwaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ikeda Naika Clinic
name: Motohisa Ikeda, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sakura Clinic
name: Tetsunari Maeda, MD
role: PRINCIPAL_INVESTIGATOR
References: