A Phase 2, Multicenter, Open-label Study to Assess the Immunogenicity of an Investigational Hib Vaccine (NU300)in Toddlers
A Phase 2, Multicenter, Randomized, Double-Blind, Immunogenicity, Reactogenicity, and Safety Study of NU300 Booster Dose Compared to ActHIB®, Both Co-administered With Prevnar 13® at 12-15 Months of Age, in Healthy Toddlers Who Have Received a Primary Series of a Licensed Hib Vaccine and Prevnar 13®
Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with Prevnar 13® over a 28 day period following the injection compared to a single booster of ACTHIB co-administered with Prevnar 13® over a 28 day period following the injection.
Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®.
Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13® following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days following injection.
調査の概要
研究の種類
入学 (予想される)
段階
- フェーズ2
連絡先と場所
研究場所
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California
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Oakland、California、アメリカ、94611
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Kentucky
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Bardstown、Kentucky、アメリカ、40004
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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:
- Written informed consent obtained from the parent or guardian of the subject
- Male or female subjects 12-15 months of age at the time of booster vaccination, who had previously received complete primary vaccination series with a licensed Hib product and Prevnar 13® in accordance with the FDA approved labels.
- Subjects for whom the investigator believes that the parent/guardian can and will comply with the requirements of the protocol
- Subjects free of obvious health problems as established by medical history and clinical examination before entering the study
Exclusion Criteria:
- Previous booster vaccination against Hib and/or Prevnar 13®
- Any confirmed or suspected Haemophilus influenzae or pneumococcal illness.
- Administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 28 days after administration of study vaccines (before the blood draw at Visit 2).
- Chronic administration of immunosuppressants or other immune-modifying drugs within 30 days prior to dosing in the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and/or clinical examination.
- Early pre-term birth (delivery before 32 weeks).
- Major congenital defects or serious chronic diseases, or serious conditions including history of seizures, apnea, etc.
- Concurrent participation in another clinical study at any time during the study period or within the previous 6 months in which the subject has been or will be exposed to an investigational or non-investigational product (pharmaceutical product, formula, or device)
- Presence of a moderate or severe illness with or without fever at the time of vaccination (fever is defined as a temperature of ≥ 38.0C [100.4F]).
- Known history of thrombocytopenia or any coagulation disorder.
- Known hypersensitivity to any of the components of the vaccines.
- Known hypersensitivity to latex.
- The subject is unable to provide an adequate blood draw for immunogenicity assays, and safety panels at Visit 1
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：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：NU300 and Prevnar 13
NU300 at a single dose of 0.5 mL IM
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|
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アクティブコンパレータ：ActHIB and Prevnar 13
ActHIB at a dose of 0.5 ml IM
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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 |
|---|---|---|
|
safety and efficacy
時間枠：one month
|
Evaluate the safety and tolerability of a single booster dose of NU300, co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®, over a 28 day period following injection Evaluate the immunogenicity, as determined by anti-PRP polysaccharide response, of a single booster dose of NU300 co-administered with Prevnar 13® compared to a single booster dose of ActHIB® co-administered with Prevnar 13®. |
one month
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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 |
|---|---|---|
|
Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13®
時間枠：one month
|
Evaluate the individual IgG antibody quantitative response to the 13 antigens in Prevnar 13® following NU300 co-administration with Prevnar 13® compared to the IgG antibody response to the pneumococcal polysaccharides following ActHIB® co-administration with Prevnar 13® 28 days following injection
|
one month
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
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
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