NCT07047521进行中（未招募）3 期
A Randomized, Double-Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of a New Formulation of Tetravalent Dengue Vaccine (TDV) Versus the Current Formulation of TDV in Healthy Adults (Aged 18-60 Years) in a Non-Endemic Area for Dengue
Takeda5 个研究点 分布在 1 个国家目标入组 496 人开始时间: 2025年11月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 496
- 试验地点
- 5
- 主要终点
- Geometric Mean Titers (GMTs) of Neutralizing Antibodies (By MNT) Against Each of the 4 Dengue Serotypes at Day 120 In the TDV (New) And TDV (Current) Groups
研究概览
简要总结
Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. The TDV in current formulation has been approved by health authorities in many countries around the world. The main aim of the study is to confirm that the TDV new formulation induces the similar immune response as approved TDV.
Healthy adults who live in an area in which dengue fever does not occur will receive 2 TDV vaccinations 3-months apart with either the new or the current TDV. Blood samples will be taken before and after the vaccinations. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 5 times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant eligibility is determined according to the following criteria:
- •Participant is aged 18 to 60 years at the time of entry into the trial.
- •Participant is male or female.
- •Participant is in good health at the time of entry into the trial, as determined by medical history, physical examination, and the clinical judgment of the investigator.
- •Participant is immunologically naive to dengue, based on negative results for the detection of anti-DENV antibodies as documented by serological testing at screening.
- •Participant has signed and dated a written informed consent form (ICF) and any required privacy authorization prior to the initiation of any trial procedures, and after the nature of the trial has been explained according to local regulatory requirements.
- •Participant can comply with trial procedures and is available for the duration of follow-up.
排除标准
- •Participant has contraindication(s), warning(s), and/or precaution(s) applicable to vaccination with TDV as specified in the IB and/or approved product label in the participating country.
- •Participant has a known hypersensitivity or allergy to any of the Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) components (including excipients).
- •Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the participant's ability to take part in the trial.
- •Participant has a history of progressive or severe neurologic disorder, seizure disorder, or neuro-inflammatory disease (eg, Guillain-Barré syndrome).
- •Participant has an illness or history of 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 involvement in this trial.
- •Participant has a known or suspected altered immunocompetence, including:
- •Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example, greater than and equal to [>=] 2 milligrams per kilograms [mg/kg] body weight/day prednisone [or equivalent] for >=14 consecutive days or >=20 mg/day prednisone [or equivalent] administered for >=14 consecutive days) within 60 days prior to Day 1 (Month [M] 0) (note: use of corticosteroids by inhaled, intranasal, intra-articular, bursal, tendon injection, or topical routes is allowed).
- •Receipt of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
- •Receipt of immunostimulants 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.
- •Hepatitis B virus infection.
- •Hepatitis C virus infection.
- •Genetic immunodeficiency.
- •Participant has known or suspected abnormalities of splenic or thymic function.
- •8. Participant has a known bleeding diathesis or any condition/medication that may be associated with a prolonged bleeding time.
- •Participant has a serious chronic or progressive disease deemed to be preclusive to trial entry, that is, not medically stable according to the judgment of the investigator.
- •Participant has a known previous infection with any flavivirus, including dengue, yellow fever, Japanese encephalitis, or tick-borne encephalitis viruses.
- •Participant has previous or planned (during the trial conduct) vaccination against any flavivirus, including dengue (investigational or licensed vaccine), yellow fever viruses, Japanese encephalitis, or tick-borne encephalitis.
- •Participant has a clinically significant active infection (as assessed by the investigator) or body temperature >= 38.0 degrees Celsius (°C) (>=100.4 degrees Fahrenhit [°F]) within 3 days of intended TDV administration.
- •Participant has used antipyretics and/or analgesic medications within 24 hours prior to vaccination. The reason for their use (prophylaxis vs treatment) must be documented. Trial entry must be delayed to allow for a full 24 hours to have passed since last use of antipyretics and/or analgesic medications.
- •Participant has a history of substance or alcohol abuse within the past 2 years.
- •Female participants who are pregnant (ie, a positive or indeterminate pregnancy test).
- •Female participants who are breastfeeding.
- •Female participants of childbearing potential1 who are sexually active and who have not used any of the acceptable contraceptive methods2 for at least 2 months prior to Day 1 (M0).
- •Female participants of childbearing potential1 who are sexually active with a non-sterilized male partner and refuse to use an acceptable contraceptive method up to 6 weeks post second TDV vaccination on Day 90 (M3), or who are planning to donate ova up to 6 weeks each post first (on Day 1 [M0]) and post second (on Day 90 [M3]) TDV administration.
- •Non-sterilized male participants who are sexually active with a female partner of childbearing potential1 and refuse to use a barrier method 4 of contraception up to 6 weeks each post first (on Day 1 [M0]) and post second (on Day 90 [M3]) TDV administration, or who are planning to donate sperm during these periods.
- •Participant has received any of the following:
- •A licensed vaccine within 14 days (for inactivated or mRNA vaccines) or 28 days (for live or vector-based [if vector amplifies in body] vaccines) prior to TDV administration.
- •A vaccine authorized for emergency use within 28 days prior to TDV administration.
- •Participant is scheduled to receive any vaccine within 28 days after TDV administration.
- •Participant is participating in any clinical trial with another investigational product 30 days prior to Day 1 (M0) or intending to participate in another clinical trial at any time during the conduct of this trial.
- •Participant has taken part in any clinical trial of a dengue or other flavivirus (example, West Nile virus, Japanese encephalitis) candidate vaccine, except if it is known that the participant received placebo in those trials.
- •Participant is planning to donate blood, organs, or tissues up to 6 weeks post second vaccination on Day 90 (M3).
- •Participant or their first-degree relatives are involved in the trial conduct.
- •Participant identified as an employee of the investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial center.
- •Participant has lived in a dengue-endemic area for >=3 months.
- •Participant has planned travel (during trial conduct) to any endemic area for dengue and other flaviviruses.
研究组 & 干预措施
Tetravalent Dengue Vaccine (TDV) (current)
Experimental
Participants will receive TDV (current approved formulation) 0.5 mL dose, subcutaneous injection, once on Day 1 (first dose) and Day 90 (second dose).
干预措施: Tetravalent Dengue Vaccine (TDV) (Biological)
Tetravalent Dengue Vaccine (TDV) (New)
Experimental
Participants will receive TDV (new formulation) dose 1, subcutaneous injection, once on Day 1 (first dose) and Day 90 (second dose).
干预措施: Tetravalent Dengue Vaccine (TDV) (Biological)
结局指标
主要结局
Geometric Mean Titers (GMTs) of Neutralizing Antibodies (By MNT) Against Each of the 4 Dengue Serotypes at Day 120 In the TDV (New) And TDV (Current) Groups
时间窗: At Day 120
GMTs of neutralizing antibodies will be measured by microneutralization test 50% \[MNT50\] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. GMTs of neutralizing antibodies (by MNT) against each of the 4 dengue serotypes at Day 120 in the TDV (new) and TDV (current) groups will be reported.
次要结局
- Seropositivity Rates Against Multiple (2, 3 or 4) Dengue Virus Serotypes at Day 120 And Day 270 In the TDV (New) And TDV (Current) Groups(At Days 120 and 270)
- Percentage of Participants With Solicited Systemic AEs for 14 days Post Vaccination (Overall and by Severity)(Within 14 days post-vaccination at Day 1 and Day 90)
- GMTs of Neutralizing Antibodies (By MNT) Against Each of the 4 Dengue Serotypes at Day 270 In the TDV (New) And TDV (Current) Groups(At Day 270)
- Seropositivity Rates Against Each of the 4 Dengue Serotypes at Day 120 And Day 270 In the TDV (New) And TDV (Current) Groups(At Days 120 and 270)
- Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) for 7 days Post Vaccination (Overall and by Severity)(Within 7 Days post-vaccination at Day 1 and Day 90)
- Percentage of Participants With Any Unsolicited Adverse Events (AEs) for 28 days Post Vaccination(Within 28 days post-vaccination at Day 1 and Day 90)
- Percentage of Participants With Serious Adverse Events (SAEs) Throughout the Study(From first vaccination (Day 1) through end of study (Day 270))
研究者
研究点 (5)
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