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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02269475
Recruitment Status : Completed
First Posted : October 21, 2014
Results First Posted : December 3, 2015
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Healthy Japanese Children Age 7 Years Through 18 Years Drug: MEDI3250 Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1369 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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 Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: MEDI3250
MEDI3250 Nasal Spray
Drug: MEDI3250
MEDI3250

Placebo Comparator: Placebo
Placebo Nasal spray
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain) [ Time Frame: through the end of the influenza surveillance period, up to end Apr (6 months) ]
    The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain)


Secondary Outcome Measures :
  1. the Incidence of Laboratory-confirmed Influenza Infection (Any Strain) [ Time Frame: through the end of the influenza surveillance period, up to end Apr (6 months) ]
    The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (any strain)

  2. the Incidence of Laboratory-confirmed Influenza Infection (Matched Strain, by Strain) [ Time Frame: through the end of the influenza surveillance period, up to end Apr (6 months) ]
    The vaccine efficacy of MEDI3250 compared to placebo against the incidence of laboratory-confirmed influenza infection (matched strain, by strain)



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269475


Locations
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Japan
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-shi, Japan
Research Site
Fukuroi-shi, Japan
Research Site
Funabashi-shi, Japan
Research Site
Gifu-shi, Japan
Research Site
Hatsukaichi-shi, Japan
Research Site
Hiroshima-shi, Japan
Research Site
Ichikawa-shi, Japan
Research Site
Isumi-shi, 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-shi, Japan
Research Site
Koga-shi, Japan
Research Site
Kumamoto-shi, Japan
Research Site
Kunitachi-shi, Japan
Research Site
Kuwana-shi, Japan
Research Site
Matsudo-shi, Japan
Research Site
Minato-ku, Japan
Research Site
Morioka-shi, Japan
Research Site
Nakano-ku, Japan
Research Site
Okayama-shi, Japan
Research Site
Ota-ku, Japan
Research Site
Sapporo-shi, Japan
Research Site
Sendai-shi, Japan
Research Site
Setagaya-ku, Japan
Research Site
Shinjuku-ku, Japan
Research Site
Shizuoka-shi, Japan
Research Site
Taito-ku, Japan
Research Site
Toshima-ku, Japan
Research Site
Tsu-shi, Japan
Research Site
Yokkaichi-shi, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Masaki Yokohama, MD Yokohama clinic
Principal Investigator: Toshiko Yamaguchi, MD Yamaguchi Clinic
Principal Investigator: Haruo Maeta, MD Maeta Pediatrics Clinic
Principal Investigator: Hideki Nakazawa, MD HIGASHIKATSUYAMA nakazawa Naika allergy Internal Medicine
Principal Investigator: Atsushi Shibasaki, MD Shibasaki internal medicine & Pediatrics Clinic
Principal Investigator: Yutaka Igarashi, MD Igarashi Children's Clinic
Principal Investigator: Keiko Mitamura, MD Eiju General Hospital
Principal Investigator: Satoshi Yamada, MD Kyouai Clinic
Principal Investigator: Kiyoshi Niwa, MD Niwa Family Clinic
Principal Investigator: Ryuta Ono, MD Kanagawa HImawari Clinic
Principal Investigator: Eiji Kato, MD Fukuiken Saiseikai Hospital
Principal Investigator: Toshikazu Takahashi, MD Takahashi Clinic
Principal Investigator: Ryouta Yoshimura, MD Yoshimura Children's Clinic
Principal Investigator: Hiroshi Taniguchi, MD Taniguchi Pediatrics Clinic
Principal Investigator: Hidehisa Shinohara, MD Shinohara Pediatrics Clinic
Principal Investigator: Michiko Tanabe, MD Tanabe Pediatrics Clinic
Principal Investigator: Haruo Kuroki, MD Sotobo Children's Clinic
Principal Investigator: Hirokazu Sato, MD Sunrise Children's Clinic
Principal Investigator: Katsumi Yamada, MD Yamada Clinic
Principal Investigator: Hiroshi Sakiyama, MD Sakiyama Pediatric Clinic
Principal Investigator: Hiroji Okawa, MD Okawa Children & Family Clinic
Principal Investigator: Junichi Ito, MD Ito ENT Clinic
Principal Investigator: Masato Morimoto, MD MORIMOTO ENT CLINIC
Principal Investigator: Masakazu Umemoto, MD Umemoto Pediatric Clinic
Principal Investigator: Tadashi Matuda, MD Matsuda Pediatrics Clinic
Principal Investigator: Sadayoshi Torigoe, MD Aquair Medical Station
Principal Investigator: Shigeru Mori, MD Momotaro Clinic
Principal Investigator: Yutaka Fujimaki, MD Fujimaki Ent Clinic
Principal Investigator: Masaki Kato, MD Kato Ear Nose Throat Clinic
Principal Investigator: Hisakuni Sekino, MD Sekino Hospital
Principal Investigator: Toshikazu Nagakura, MD Yoga Allergy Clinic
Principal Investigator: Ichiro Ogiwara, MD Ogiwara Ent Clinic
Principal Investigator: Akitoshi Funato, MD Medical corporation Seisyuukai Funato Clinic
Principal Investigator: Naohisa Hoshino, MD Medical corporation Ryoshukai Kanauchi Medical Clinic
Principal Investigator: Munechika Noguchi, MD Social medical corporation IHL ShinagawaEastOne Medical Clinic
Principal Investigator: Chiaki Noguchi, MD Shinkoiwa Ekimae Sougou Clinic
Principal Investigator: Kimihiko Yukisada, MD Yukisada Clinic for internal disease
Principal Investigator: Hiroshi Shimomura, MD Medical corporation Junyokai Musashino General Clinic
Principal Investigator: Mitsuhiro Nemoto, MD Nemoto-geka-seikeigeka
Principal Investigator: Naoki Kawai, MD Kawai Naika Iin
Principal Investigator: Shigehiro Yazima, MD Yajima Children's Clinic
Principal Investigator: Tetsuhiko Nagao, MD Midorino Clinic
Principal Investigator: Kenjiro Nakamura, MD Tenjin Sogo Clinic
Principal Investigator: Wataru Ikematsu, MD Kobori Building Clinic
Principal Investigator: Shiro Kimura, MD Kimura Shiro Clinic
Principal Investigator: Mieko Ueda, MD Ueda Naika Clinic
Principal Investigator: Minako Iwaya, MD Iwaya Children's Clinic
Principal Investigator: Motohisa Ikeda, MD Ikeda Naika Clinic
Principal Investigator: Tetsunari Maeda, MD Sakura Clinic

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02269475     History of Changes
Other Study ID Numbers: D2560C00006
First Posted: October 21, 2014    Key Record Dates
Results First Posted: December 3, 2015
Last Update Posted: April 4, 2017
Last Verified: February 2017

Keywords provided by AstraZeneca:
Efficacy
Safety
Tolerability
MEDI3250
Japanese children