A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years
2016年4月12日 更新者:Sanofi Pasteur, a Sanofi Company
Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Subjects Aged 6 Months to 9 Years
The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children.
Primary Objectives:
- To describe the immunogenicity of the candidate vaccines after each injection.
- To describe the safety of the candidate vaccines after each injection.
調査の概要
状態
完了
詳細な説明
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
研究の種類
介入
入学 (実際)
474
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Florida
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Miami Beach、Florida、アメリカ、33141
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Georgia
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Marietta、Georgia、アメリカ、30062
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Woodstock、Georgia、アメリカ、30189
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Kentucky
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Crestview Hills、Kentucky、アメリカ、41017
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Louisville、Kentucky、アメリカ、40291
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Maddisonville、Kentucky、アメリカ、42431
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Louisiana
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Metairie、Louisiana、アメリカ、70006
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Nevada
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Las Vegas、Nevada、アメリカ、89104
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New York
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Rochester、New York、アメリカ、14609
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Pennsylvania
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Hermitage、Pennsylvania、アメリカ、16148
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Pittsburgh、Pennsylvania、アメリカ、15237
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Pittsburgh、Pennsylvania、アメリカ、15241
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Rhode Island
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Cranston、Rhode Island、アメリカ、O2920
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South Carolina
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Barnwell、South Carolina、アメリカ、29812
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Texas
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Austin、Texas、アメリカ、78705
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Fort Worth、Texas、アメリカ、76135
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San Angelo、Texas、アメリカ、76904
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Utah
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Orem、Utah、アメリカ、84057
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South Jordan、Utah、アメリカ、84095
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Springville、Utah、アメリカ、84663
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
6ヶ月~9年 (子)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria :
All subjects:
- Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 7 to 9 years
- Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
Subjects aged 3 to 9 years:
- Healthy children aged 3 to 9 years on the day of inclusion
Subjects aged 6 to 35 months:
- Healthy infants and toddlers aged 6 to 35 months on the day of inclusion
- Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
Exclusion Criteria :
- Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
- Planned participation in another clinical trial during the present trial period
- Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- Planned receipt of any vaccine prior to the Day 42 blood sample
- Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C
- Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
- Chronic illness that in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
- Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
- Personal or family history of Guillain-Barré syndrome
- Active neoplastic disease or a history of any hematologic malignancy
- Known seizure/epilepsy history and/or taking anti-seizure medication
- Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
- Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:防止
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1
|
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
|
実験的:A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
|
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
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プラセボコンパレーター:Placebo Group
Participants will receive a placebo vaccine
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0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
時間枠:Pre-vaccination (Day 0) and 21 days post-vaccination
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Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
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Pre-vaccination (Day 0) and 21 days post-vaccination
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Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
時間枠:Pre-vaccination (Day 0) and Day 21 post-vaccination
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Seroprotection: Antibody titer of ≥ 40 1/dil.
Antibody titers were determined by the hemagglutination inhibition (HAI) test.
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Pre-vaccination (Day 0) and Day 21 post-vaccination
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Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
時間枠:Pre-vaccination (Day 0) and 21 days post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
時間枠:Pre-vaccination (Day 0) and 21 days post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
時間枠:Pre-vaccination (Day 0) and Day 21 post-vaccination
|
Seroprotection: Antibody titer ≥ 40 1/dil.
Antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and Day 21 post-vaccination
|
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
時間枠:Pre-vaccination (Day 0) and Day 21 post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and Day 21 post-vaccination
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Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months
時間枠:Days 0 to 7 post-vaccination
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Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising).
Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
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Days 0 to 7 post-vaccination
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Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months
時間枠:Days 0 to 7 post-vaccination
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Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising).
Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
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Days 0 to 7 post-vaccination
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Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years
時間枠:Days 0 to 7 post vaccination
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Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising).
Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
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Days 0 to 7 post vaccination
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, Reeves-Hoche MK, Denis M. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine. 2011 Feb 11;29(8):1569-75. doi: 10.1016/j.vaccine.2010.12.116. Epub 2011 Jan 8.
- Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15.
便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2009年8月1日
一次修了 (実際)
2010年3月1日
研究の完了 (実際)
2010年6月1日
試験登録日
最初に提出
2009年8月3日
QC基準を満たした最初の提出物
2009年8月4日
最初の投稿 (見積もり)
2009年8月6日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年4月14日
QC基準を満たした最後の更新が送信されました
2016年4月12日
最終確認日
2016年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- FUF15
- UTN: U1111-1111-4713
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。