A Study to Test the Safety and Effectiveness of an Investigational Vaccine in Infants (V419-002)
Safety, Tolerability, and Immunogenicity of Four Different Formulations of a Liquid Hexavalent Combination Vaccine, HR5I (Haemophilus Influenzae Type b Conjugate, Recombinant Hepatitis B Surface Antigen, Diphtheria Toxoid, Tetanus Toxoid, 5-Component Acellular Pertussis Vaccine, and Inactivated Poliovirus Type 1, 2, and 3), When Administered to Healthy Hepatitis B Vaccine-Naïve Infants at 2, 3, 4, and 12 to 14 Months of Age
調査の概要
詳細な説明
Participants will be randomized into 4 arms:
AR51 (12, 10): arm receiving vaccine formulation containing 12 mcg of polyribosylribitol phosphate (PRP) conjugates to tetanus toxoid (PRP-T) and 10 mcg of Hepatitis B surface antigen (HBsAg)
PR51 (3, 10): arm receiving vaccine formulation containing 3 mcg of PRP conjugated to the outer membrane protein complex of Neisseria meningitides (PRP-OMPC) and 10 mcg of HBsAg
PR51 (6, 10): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 10 mcg of HBsAg
PR51 (6, 15): arm receiving vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg
研究の種類
入学 (実際)
段階
- フェーズ2
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:
- Healthy infants 2 months of age who have not received prior vaccinations for Haemophilus influenzae type b (Hib), hepatitis B, Diptheria/Pertussis/Tetanus (DPT), or Polio
Exclusion Criteria :
- Documented HIV infection (child or mother)
- Documented HBsAg-seropositivity (child or mother)
- History of invasive Hib disease, hepatitis B, diphtheria, tetanus, pertussis, or poliovirus infection
- History of seizure disorder, developmental delay, or any other neurologic disorder
- Underlying medical conditions such as inborn errors of metabolism, failure to thrive, or any major congenital abnormalities requiring surgery
- Prior or anticipated receipt of immune globulin, blood, or blood products
- Known hypersensitivity to any component of the investigational vaccines being administered in this protocol
- Any history or condition that would exclude the child from receiving any vaccine administered under this protocol
- Any condition that, in the opinion of the investigator, may interfere with the evaluation of the study objectives
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:ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的:AR51 (12, 10)
Participants were vaccinated with 0.5 ml of AR51 (12, 10) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age.
|
12 mcg の PRP-T と 10 mcg の HBsAg を含むワクチン製剤
|
実験的:PR51 (3, 10)
Participants were vaccinated with 0.5 ml of PR51 (3, 10) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age.
|
PRP-OMPC 3 mcg と HBsAg 10 mcg を含むワクチン製剤
|
実験的:PR51 (6, 10)
Participants were vaccinated with 0.5 ml of PR51 (6, 10) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age.
|
PRP-OMPC 6 mcg と HBsAg 10 mcg を含むワクチン製剤
|
実験的:PR51 (6, 15)
Participants were vaccinated with 0.5 ml of PR51 (6, 15) formulation via intramuscular injection as a primary series at 2, 3, and 4 months of age, and as a booster at 12 to 14 months of age.
|
vaccine formulation containing 6 mcg of PRP-OMPC and 15 mcg of HBsAg
|
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 |
時間枠 |
---|---|
Percentage of participants with level of anti-PRP antibodies >1.0 μg/mL at the Postdose 3 time point
時間枠:At 5 months of age (1 month after 3rd vaccination)
|
At 5 months of age (1 month after 3rd vaccination)
|
Percentage of participants with level of anti-HBsAg antibodies ≥10 mIU/L at the Postdose 3 time point
時間枠:At 5 months of age (1 month after 3rd vaccination)
|
At 5 months of age (1 month after 3rd vaccination)
|
Percentage of participants with a ≥4-fold rise in levels of antibodies to pertussis antigens (toxoid [PTxd], Filamentous Hemagglutinin [FHA], Fimbria 2 & Fimbria 3 [FIM], and Pertactin [PRN]) at the Postdose 3 time point
時間枠:At 5 months of age (1 month after 3rd vaccination)
|
At 5 months of age (1 month after 3rd vaccination)
|
Percentage of participants with level of anti-diphtheria antibodies ≥0.01 IU/mL at the Postdose 3 time point
時間枠:At 5 months of age (1 month after 3rd vaccination)
|
At 5 months of age (1 month after 3rd vaccination)
|
Percentage of participants with level of anti-tetanus antibodies ≥0.01 IU/mL at the Postdose 3 time point
時間枠:At 5 months of age (1 month after 3rd vaccination)
|
At 5 months of age (1 month after 3rd vaccination)
|
Percentage of participants with neutralizing anti-poliovirus antibodies (Types 1, 2, and 3) at ≥1:8 dilution at the Postdose 3 time point
時間枠:At 5 months of age (1 month after 3rd vaccination)
|
At 5 months of age (1 month after 3rd vaccination)
|
二次結果の測定
結果測定 |
時間枠 |
---|---|
少なくとも 1 つの有害事象 (AE) のある参加者の数
時間枠:初回接種から最終接種後14日まで(最長14.5ヶ月)
|
初回接種から最終接種後14日まで(最長14.5ヶ月)
|
AEのために試験治療を中止した参加者の数
時間枠:初回接種から最終接種後14日まで(最長14.5ヶ月)
|
初回接種から最終接種後14日まで(最長14.5ヶ月)
|
協力者と研究者
スポンサー
出版物と役立つリンク
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
- V419-002
- 2007_580 (その他の識別子:Merck Registration Number)
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。
AR51 (12、10)の臨床試験
-
MeiraGTx UK II Ltd完了頭頸部がん | 放射線誘発性耳下腺機能低下症 | 放射線治療による口腔乾燥症アメリカ, カナダ
-
United States Naval Medical Center, San Diego完了
-
Lithuanian University of Health SciencesResearch Council of Lithuania完了