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

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.

Conditions

• Healthy Japanese Children Age 7 Years Through 18 Years

Interventions

DRUG

MEDI3250

MEDI3250

DRUG

Placebo

Placebo

Sponsors & Collaborators

• AstraZeneca

  lead INDUSTRY

Principal Investigators

• Masaki Yokohama, MD · Yokohama clinic

• Toshiko Yamaguchi, MD · Yamaguchi Clinic

• Haruo Maeta, MD · Maeta Pediatrics Clinic

• Hideki Nakazawa, MD · HIGASHIKATSUYAMA nakazawa Naika allergy Internal Medicine

• Atsushi Shibasaki, MD · Shibasaki internal medicine & Pediatrics Clinic

• Yutaka Igarashi, MD · Igarashi Children's Clinic

• Keiko Mitamura, MD · Eiju General Hospital

• Satoshi Yamada, MD · Kyouai Clinic

• Kiyoshi Niwa, MD · Niwa Family Clinic

• Ryuta Ono, MD · Kanagawa HImawari Clinic

• Eiji Kato, MD · Fukuiken Saiseikai Hospital

• Toshikazu Takahashi, MD · Takahashi Clinic

• Ryouta Yoshimura, MD · Yoshimura Children's Clinic

• Hiroshi Taniguchi, MD · Taniguchi Pediatrics Clinic

• Hidehisa Shinohara, MD · Shinohara Pediatrics Clinic

• Michiko Tanabe, MD · Tanabe Pediatrics Clinic

• Haruo Kuroki, MD · Sotobo Children's Clinic

• Hirokazu Sato, MD · Sunrise Children's Clinic

• Katsumi Yamada, MD · Yamada Clinic

• Hiroshi Sakiyama, MD · Sakiyama Pediatric Clinic

• Hiroji Okawa, MD · Okawa Children & Family Clinic

• Junichi Ito, MD · Ito ENT Clinic

• Masato Morimoto, MD · MORIMOTO ENT CLINIC

• Masakazu Umemoto, MD · Umemoto Pediatric Clinic

• Tadashi Matuda, MD · Matsuda Pediatrics Clinic

• Sadayoshi Torigoe, MD · Aquair Medical Station

• Shigeru Mori, MD · Momotaro Clinic

• Yutaka Fujimaki, MD · Fujimaki Ent Clinic

• Masaki Kato, MD · Kato Ear Nose Throat Clinic

• Hisakuni Sekino, MD · Sekino Hospital

• Toshikazu Nagakura, MD · Yoga Allergy Clinic

• Ichiro Ogiwara, MD · Ogiwara Ent Clinic

• Akitoshi Funato, MD · Medical corporation Seisyuukai Funato Clinic

• Naohisa Hoshino, MD · Medical corporation Ryoshukai Kanauchi Medical Clinic

• Munechika Noguchi, MD · Social medical corporation IHL ShinagawaEastOne Medical Clinic

• Chiaki Noguchi, MD · Shinkoiwa Ekimae Sougou Clinic

• Kimihiko Yukisada, MD · Yukisada Clinic for internal disease

• Hiroshi Shimomura, MD · Medical corporation Junyokai Musashino General Clinic

• Mitsuhiro Nemoto, MD · Nemoto-geka-seikeigeka

• Naoki Kawai, MD · Kawai Naika Iin

• Shigehiro Yazima, MD · Yajima Children's Clinic

• Tetsuhiko Nagao, MD · Midorino Clinic

• Kenjiro Nakamura, MD · Tenjin Sogo Clinic

• Wataru Ikematsu, MD · Kobori Building Clinic

• Shiro Kimura, MD · Kimura Shiro Clinic

• Mieko Ueda, MD · Ueda Naika Clinic

• Minako Iwaya, MD · Iwaya Children's Clinic

• Motohisa Ikeda, MD · Ikeda Naika Clinic

• Tetsunari Maeda, MD · Sakura Clinic

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2015-04-30

Completion

2015-04-30

Countries

• Japan

Study Locations