Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine
Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Quadrivalent, Influenza Vaccine (2014-2015 Formulation)
The study will evaluate the safety and immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with the Advisory Committee on Immunization Practices (ACIP) recommendations, in children 6 months to < 9 years of age.
Objective:
- To describe the safety of the 2014-2015 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule, in accordance with ACIP recommendations, in children 6 months to < 9 years of age.
Observational objectives:
- To describe the immunogenicity of the 2014-2015 formulation of Fluzone Quadrivalent vaccine, administered in a 1- or 2-dose schedule in accordance with ACIP recommendations, in children 6 months to < 9 years of age.
- To submit available sera from each subject to Center for Biologics Evaluation and Research (CBER) for further analysis by the WHO, the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA) to support formulation recommendations for subsequent influenza vaccines.
調査の概要
状態
条件
詳細な説明
Participants will be assigned to the appropriate age group based on the age at the time of enrollment. Participants will receive a dose of Fluzone Quadrivalent vaccine, those for whom 2 doses of influenza vaccine are recommended per ACIP guidance, will receive a second dose during Visit 2 (28 days after Visit 1).
Solicited adverse event (AE) information will be collected for 7 days after each vaccination, unsolicited AE information will be collected from Visit 1 to Visit 2, or to Visit 3 for those subjects receiving 2 doses. Serious adverse event (SAE) information will be collected the study. Immunogenicity will be evaluated in all participants prior to vaccination and at Day 28 after the final vaccination.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Kentucky
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Bardstown、Kentucky、アメリカ、40040
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Utah
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Salt Lake City、Utah、アメリカ、84121
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Subject is 6 months to < 9 years of age on the day of first study vaccination (study product administration)
- Subject and parent/legally acceptable representative are willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
- Assent form has been signed and dated by subjects 7 to < 9 years of age, and informed consent form has been signed and dated by parent(s) or another legally acceptable representative for subjects 6 months to < 9 years of age.
- For subjects 6 months to < 12 months of age, born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg (5.5 lbs).
Exclusion Criteria:
- Known systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components, or a history of a life-threatening reaction to Fluzone Quadrivalent vaccine or to a vaccine containing any of the same substances (the complete list of vaccine components is included in the Prescribing Information).
- History of serious adverse reaction to any influenza vaccine.
- Receipt of any vaccine within 30 days before receiving study vaccine, or plans to receive another vaccine before Visit 2 for subjects receiving 1 dose of influenza vaccine or Visit 3 for subjects receiving 2 doses of influenza vaccine.
- Participation in another interventional clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the first study vaccination or during the course of the study unless no intervention for the other study occurred within the 30 days prior to the first study vaccination and none are planned before the subject would complete safety surveillance for the present study.
- Prior vaccination with any formulation of 2014-2015 influenza vaccine.
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
- Thrombocytopenia, which may be a contraindication for intramuscular vaccination, at the discretion of the Investigator.
- Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
- Personal history of Guillain-Barré Syndrome.
- Known or suspected congenital or acquired immunodeficiency; or receipt of 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).
- Personal history of clinically significant developmental delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
- Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion.
- Known seropositivity for human immunodeficiency virus, hepatitis B, or hepatitis C.
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 100.4°F). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months.
- Identified as a natural or adopted child of the Investigator or an employee with direct involvement in the proposed study.
研究計画
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:なし(オープンラベル)
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:Fluzone Study Group 1
Participants at 6 months to < 36 months age at enrollment
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0.25 mL, Intramuscular (Pediatric Dose, 2014-2015 formulation)
他の名前:
0.5 mL, Intramuscular (2014-2015 formulation)
他の名前:
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実験的:Fluzone Study Group 2
Participants at 3 years to < 9 years of age at enrollment
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0.25 mL, Intramuscular (Pediatric Dose, 2014-2015 formulation)
他の名前:
0.5 mL, Intramuscular (2014-2015 formulation)
他の名前:
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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 |
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Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
時間枠:Day 0 up to Day 7 post-any injection
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Solicited Injection-site: 6 to < 36 months - Tenderness, Erythema, and Swelling; 3 to < 9 years - Pain, Erythema, and Swelling. Solicited systemic reactions: 6 to < 36 months - Fever (Temperature), Vomiting, Crying abnormal, Drowsiness, Appetite lost, and Irritability; 3 to < 9 years - Fever, Headache, Malaise, and Myalgia. Grade 3: Fever, > 39.5˚C (6 to < 36 months), ≥ 39.0˚C (3 to < 9 years); Vomiting, ≥ 6 episodes/24 hours or requires parenteral hydration; Crying abnormal, > 3 hours; Drowsiness, Sleeping often/difficult to wake; Appetite lost, Refuses ≥ 3 or most meals; Irritability, Inconsolable; Headache, Malaise, and Myalgia, Significant, prevents daily activity. |
Day 0 up to Day 7 post-any injection
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Geometric Mean Titers (GMTs) of Influenza Antibodies Before and Post Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Influenza Vaccine
時間枠:Day 0 (pre-vaccination) and Day 28 post-final vaccination
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Geometric titers of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
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Day 0 (pre-vaccination) and Day 28 post-final vaccination
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Number of Participants With Seroprotection Before and Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
時間枠:Day 0 (pre-vaccination) and Day 28 post-final vaccination
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Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
Seroprotection was defined as a titer ≥ 40 (l/dil) at pre-vaccination and at 28 days after the final vaccination.
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Day 0 (pre-vaccination) and Day 28 post-final vaccination
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Percentage of Participants With Seroconversion Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
時間枠:Day 28 post-final vaccination
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Influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
Seroconversion is defined as either a pre-vaccination HAI titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer.
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Day 28 post-final vaccination
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Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With the 2014-2015 Formulation of Fluzone® Quadrivalent Vaccine
時間枠:Day 28 post-final vaccination
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Geometric titer ratios of influenza antibodies were assessed using the hemagglutination inhibition (HAI) assay.
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Day 28 post-final vaccination
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協力者と研究者
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- GRC56
- U1111-1143-8966 (その他の識別子:WHO)
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。
Fluzone® Quadrivalent Influenza Vaccine, No Preservativeの臨床試験
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GlaxoSmithKline完了
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Sanofi Pasteur, a Sanofi Company完了
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Sanofi Pasteur, a Sanofi Company完了
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Sanofi Pasteur, a Sanofi Company完了
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Sanofi Pasteur, a Sanofi Company完了
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Sanofi Pasteur, a Sanofi Company募集
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Stanford UniversityNational Institute of Allergy and Infectious Diseases (NIAID)完了