Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) in Adolescents in Non-Endemic Area(s)
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of Subcutaneous Administration of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescent Subjects in Non-Endemic Area(s) for Dengue
調査の概要
詳細な説明
The vaccine tested in this study was tetravalent dengue vaccine (TDV). TDV was tested to assess the safety and immunogenicity in healthy adolescents in non-endemic area(s) for dengue.
The study enrolled 400 healthy participants. Participants were randomized in 3:1 ratio to receive:
- TDV 0.5 mL subcutaneous injection
- Placebo normal saline solution (0.9% NaCl) for injection.
In each trial group, participants received 2-dose schedule of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3), but not all participants received both doses (8 subjects discontinued the trial before receiving the second dose).
This multi-center trial was conducted in Mexico. The overall time to participate in this study was 270 days. Participants had multiple visits to the clinic including a final visit at Day 270.
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Ciudad de Mexico、メキシコ、09360
- Biodextra, S.A. de C.V.
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Mexico City、メキシコ、06720
- Hospital Infantil de México Federico Gómez
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Mexico City、メキシコ、04530
- Instituto Nacional de Pediatría (INP)
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Mexico City、メキシコ、ZC 03100
- Mexico Centre for Clinical Research
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Mexico City、メキシコ
- Centro de Atencion E Investigacion Medica (CAIMED) Mexico DF
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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:
- The participant is aged 12 to 17 years, inclusive;
- Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and the clinical judgment of the Investigator.
- The participant/the participant's legally authorized representative (LAR) signs and dates a written, informed consent/assent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
- Individuals who can comply with trial procedures and are available for the duration of follow-up.
Exclusion Criteria:
- Has an elevated oral temperature (≥38°C or 100.4°F) within 3 days of the intended date of vaccination.
- Known hypersensitivity or allergy to any of the vaccine components.
- Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the trial.
- Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barre syndrome).
- History or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose additional risk to the participant due to participation in the trial.
Has known or suspected impairment/alteration of immune function, including:
- Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (M0) (use of inhaled, intranasal, or topical corticosteroids is allowed).
- Receipt of parenteral steroids (equivalent to 20 mg/day prednisone ≥12 weeks/≥ 2 mg/kg body weight/day prednisone ≥2 weeks) within 60 days prior to Day 1 (M0).
- Administration of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
- Receipt of immune-stimulants within 60 days prior to Day 1 (M0).
- Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).
- Human immunodeficiency virus (HIV) infection or HIV-related disease.
- Genetic immunodeficiency.
- Has abnormalities of splenic or thymic function.
- Has a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding.
- Has any serious chronic or progressive disease according to judgment of the Investigator (e.g., neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
- Has body mass index (BMI) greater than or equal to 35 kg/m^2 (= weight in kg/[height in square meters]).
- Individuals participating in any clinical trial with another investigational product 30 days prior to Day 1 (M0) or intent to participate in another clinical trial at any time during the conduct of this trial.
- Has received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this trial or who are planning to receive any vaccine within 28 days of trial vaccine administration.
- Individuals involved in the trial conduct or their first degree relatives.
- Has history of substance or alcohol abuse within the past 2 years.
- Female participants who are pregnant or breastfeeding.
- Females of childbearing potential who are sexually active, and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (M0).
- Females of childbearing potential who are sexually active, and who refuse to use an acceptable contraceptive method up to 6 weeks after the last dose of trial vaccine. In addition, they must be advised not to donate ova during this period.
- Any positive or indeterminate pregnancy test.
- Previous and planned vaccination (during the trial conduct), against any flaviviruses including dengue, yellow fever (YF), Japanese encephalitis (JE) viruses or tick-borne encephalitis.
- Previous participation in any clinical trial of a dengue or other flavivirus (eg, West Nile [WN] virus) candidate vaccine, except for participants who received placebo in those trials.
- Participants with documented or suspected disease caused by a flavivirus such as dengue, Zika, YF, JE, WN fever, tick-borne encephalitis or Murray Valley encephalitis.
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:処理
- 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:Tetravalent Dengue Vaccine (TDV)
TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose)
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TDV皮下注射
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プラセボコンパレーター:Placebo
TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
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通常の生理食塩水 (0.9% NaCl) 皮下注射
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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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Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120
時間枠:One month post second dose (Day 120)
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GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes.
The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Seropositivity is defined as reciprocal neutralizing titer ≥10.
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One month post second dose (Day 120)
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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 Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270
時間枠:Six months post second dose (Day 270)
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GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes.
The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
Seropositivity is defined as reciprocal neutralizing titer ≥10.
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Six months post second dose (Day 270)
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Seropositivity Rates for Each of the 4 Dengue Serotypes
時間枠:One month and six months post second dose (Day 120 and Day 270)
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Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies.
Seropositivity defined as a reciprocal neutralizing titer ≥10.
The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.
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One month and six months post second dose (Day 120 and Day 270)
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Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes
時間枠:One month and six months post second dose (Day 120 and Day 270)
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Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies.
Seropositivity was defined as a reciprocal neutralizing titer ≥10.
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One month and six months post second dose (Day 120 and Day 270)
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Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
時間枠:Within 7 days after each vaccination
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Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (<2.5 cm, mild: 2.5-5 cm, moderate: >5 to <=10 cm, severe: >10 cm) and swelling (edema/induration) (<2.5 cm, mild: 2.5-5 cm, moderate: >5 to <=10 cm, severe: >10 cm).
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Within 7 days after each vaccination
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Percentage of Participants With Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
時間枠:Within 14 days after each vaccination
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Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, tiredness or weakness (asthenia), feeling of discomfort (malaise) and muscle pain (myalgia).
Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment.
Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity.
A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was derived from a daily temperature reading recorded within 14 days after vaccination.
Fever was excluded from the overall count as no severity grading was applied for it.
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Within 14 days after each vaccination
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Percentage of Participants With Any Unsolicited Adverse Events (AEs) Following Each Vaccination
時間枠:Within 28 days after each vaccination
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An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.
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Within 28 days after each vaccination
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Percentage of Participants With Medically Attended AEs (MAAEs) Throughout the Study
時間枠:From first vaccination (Day 1) through end of study (Day 270)
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MAAEs were defined as AEs leading to a medical visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria.
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From first vaccination (Day 1) through end of study (Day 270)
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研究を通して深刻な有害事象(SAE)の参加者の割合
時間枠:最初の予防接種(1日目)から研究終了(270日目)まで
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SAEは、死をもたらす厄介な医療の発生または効果として定義され、生命を脅かす、既存の入院または既存の入院の延長を必要とし、持続的または重大な障害/無能力をもたらすこと、先天性の異常/出生障害であるか、上記の基準以外の理由により、他の理由により医学的に重要です。
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最初の予防接種(1日目)から研究終了(270日目)まで
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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 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- DEN-315
- U1111-1192-7827 (その他の識別子:World Health Organization)
- RNEC-2017-DEN-315 (レジストリ識別子:Mexico)
- 2018-003980-77 (EudraCT番号)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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