A Phase3 Study to Evaluate the Efficacy and Safety of MEDI3250 in Healthy Japanese Children Age 7 Years Through 18 Years

NCT ID: NCT02269475

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1369 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-04-30

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.

Conditions

Healthy Japanese Children Age 7 Years Through 18 Years

Study Design

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

Study Groups

MEDI3250

MEDI3250 Nasal Spray

Group Type: EXPERIMENTAL

MEDI3250

Intervention Type: DRUG

MEDI3250

Placebo

Placebo Nasal spray

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

MEDI3250

MEDI3250

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masaki Yokohama, MD

Role: PRINCIPAL_INVESTIGATOR

Yokohama clinic

Toshiko Yamaguchi, MD

Role: PRINCIPAL_INVESTIGATOR

Yamaguchi Clinic

Haruo Maeta, MD

Role: PRINCIPAL_INVESTIGATOR

Maeta Pediatrics Clinic

Hideki Nakazawa, MD

Role: PRINCIPAL_INVESTIGATOR

HIGASHIKATSUYAMA nakazawa Naika allergy Internal Medicine

Atsushi Shibasaki, MD

Role: PRINCIPAL_INVESTIGATOR

Shibasaki internal medicine & Pediatrics Clinic

Yutaka Igarashi, MD

Role: PRINCIPAL_INVESTIGATOR

Igarashi Children's Clinic

Keiko Mitamura, MD

Role: PRINCIPAL_INVESTIGATOR

Eiju General Hospital

Satoshi Yamada, MD

Role: PRINCIPAL_INVESTIGATOR

Kyouai Clinic

Kiyoshi Niwa, MD

Role: PRINCIPAL_INVESTIGATOR

Niwa Family Clinic

Ryuta Ono, MD

Role: PRINCIPAL_INVESTIGATOR

Kanagawa HImawari Clinic

Eiji Kato, MD

Role: PRINCIPAL_INVESTIGATOR

Fukuiken Saiseikai Hospital

Toshikazu Takahashi, MD

Role: PRINCIPAL_INVESTIGATOR

Takahashi Clinic

Ryouta Yoshimura, MD

Role: PRINCIPAL_INVESTIGATOR

Yoshimura Children's Clinic

Hiroshi Taniguchi, MD

Role: PRINCIPAL_INVESTIGATOR

Taniguchi Pediatrics Clinic

Hidehisa Shinohara, MD

Role: PRINCIPAL_INVESTIGATOR

Shinohara Pediatrics Clinic

Michiko Tanabe, MD

Role: PRINCIPAL_INVESTIGATOR

Tanabe Pediatrics Clinic

Haruo Kuroki, MD

Role: PRINCIPAL_INVESTIGATOR

Sotobo Children's Clinic

Hirokazu Sato, MD

Role: PRINCIPAL_INVESTIGATOR

Sunrise Children's Clinic

Katsumi Yamada, MD

Role: PRINCIPAL_INVESTIGATOR

Yamada Clinic

Hiroshi Sakiyama, MD

Role: PRINCIPAL_INVESTIGATOR

Sakiyama Pediatric Clinic

Hiroji Okawa, MD

Role: PRINCIPAL_INVESTIGATOR

Okawa Children & Family Clinic

Junichi Ito, MD

Role: PRINCIPAL_INVESTIGATOR

Ito ENT Clinic

Masato Morimoto, MD

Role: PRINCIPAL_INVESTIGATOR

MORIMOTO ENT CLINIC

Masakazu Umemoto, MD

Role: PRINCIPAL_INVESTIGATOR

Umemoto Pediatric Clinic

Tadashi Matuda, MD

Role: PRINCIPAL_INVESTIGATOR

Matsuda Pediatrics Clinic

Sadayoshi Torigoe, MD

Role: PRINCIPAL_INVESTIGATOR

Aquair Medical Station

Shigeru Mori, MD

Role: PRINCIPAL_INVESTIGATOR

Momotaro Clinic

Yutaka Fujimaki, MD

Role: PRINCIPAL_INVESTIGATOR

Fujimaki Ent Clinic

Masaki Kato, MD

Role: PRINCIPAL_INVESTIGATOR

Kato Ear Nose Throat Clinic

Hisakuni Sekino, MD

Role: PRINCIPAL_INVESTIGATOR

Sekino Hospital

Toshikazu Nagakura, MD

Role: PRINCIPAL_INVESTIGATOR

Yoga Allergy Clinic

Ichiro Ogiwara, MD

Role: PRINCIPAL_INVESTIGATOR

Ogiwara Ent Clinic

Akitoshi Funato, MD

Role: PRINCIPAL_INVESTIGATOR

Medical corporation Seisyuukai Funato Clinic

Naohisa Hoshino, MD

Role: PRINCIPAL_INVESTIGATOR

Medical corporation Ryoshukai Kanauchi Medical Clinic

Munechika Noguchi, MD

Role: PRINCIPAL_INVESTIGATOR

Social medical corporation IHL ShinagawaEastOne Medical Clinic

Chiaki Noguchi, MD

Role: PRINCIPAL_INVESTIGATOR

Shinkoiwa Ekimae Sougou Clinic

Kimihiko Yukisada, MD

Role: PRINCIPAL_INVESTIGATOR

Yukisada Clinic for internal disease

Hiroshi Shimomura, MD

Role: PRINCIPAL_INVESTIGATOR

Medical corporation Junyokai Musashino General Clinic

Mitsuhiro Nemoto, MD

Role: PRINCIPAL_INVESTIGATOR

Nemoto-geka-seikeigeka

Naoki Kawai, MD

Role: PRINCIPAL_INVESTIGATOR

Kawai Naika Iin

Shigehiro Yazima, MD

Role: PRINCIPAL_INVESTIGATOR

Yajima Children's Clinic

Tetsuhiko Nagao, MD

Role: PRINCIPAL_INVESTIGATOR

Midorino Clinic

Kenjiro Nakamura, MD

Role: PRINCIPAL_INVESTIGATOR

Tenjin Sogo Clinic

Wataru Ikematsu, MD

Role: PRINCIPAL_INVESTIGATOR

Kobori Building Clinic

Shiro Kimura, MD

Role: PRINCIPAL_INVESTIGATOR

Kimura Shiro Clinic

Mieko Ueda, MD

Role: PRINCIPAL_INVESTIGATOR

Ueda Naika Clinic

Minako Iwaya, MD

Role: PRINCIPAL_INVESTIGATOR

Iwaya Children's Clinic

Motohisa Ikeda, MD

Role: PRINCIPAL_INVESTIGATOR

Ikeda Naika Clinic

Tetsunari Maeda, MD

Role: PRINCIPAL_INVESTIGATOR

Sakura Clinic

Locations

Research Site

Akashi-shi, , Japan

Research Site

Chofu-shi, , Japan

Research Site

Fuchu-shi, , Japan

Research Site

Fujimi-shi, , Japan

Research Site

Fukui-shi, , Japan

Research Site

Fukuoka, , Japan

Research Site

Fukuroi-shi, , Japan

Research Site

Funabashi-shi, , Japan

Research Site

Gifu, , Japan

Research Site

Hatsukaichi-shi, , Japan

Research Site

Hiroshima, , Japan

Research Site

Ichikawa-shi, , Japan

Research Site

Isumi, , Japan

Research Site

Iwate-gun, , Japan

Research Site

Katsushika-ku, , Japan

Research Site

Kawasaki-shi, , Japan

Research Site

Kisarazu-shi, , Japan

Research Site

Kiyose-shi, , Japan

Research Site

Kobe, , Japan

Research Site

Koga-shi, , Japan

Research Site

Kumamoto, , Japan

Research Site

Kunitachi-shi, , Japan

Research Site

Kuwana-shi, , Japan

Research Site

Matsudo-shi, , Japan

Research Site

Minatoku, , Japan

Research Site

Morioka, , Japan

Research Site

Nakano, , Japan

Research Site

Okayama, , Japan

Research Site

Ōta-ku, , Japan

Research Site

Sapporo, , Japan

Research Site

Sendai, , Japan

Research Site

Setagaya-ku, , Japan

Research Site

Shinjuku-ku, , Japan

Research Site

Shizuoka, , Japan

Research Site

Taito-ku, , Japan

Research Site

Toshima-ku, , Japan

Research Site

Tsu, , Japan

Research Site

Yokkaichi-shi, , Japan

Countries

Japan

Other Identifiers

D2560C00006

Identifier Type: -

Identifier Source: org_study_id