E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Infection with dengue virus,a ribonucleic acid(RNA) virus that occurs as 4 recognized serotypes:wild-type dengue virus(DENV)-1,2,3,4, transmitted from human to human by mosquitoes causes dengue fever. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012312 |
E.1.2 | Term | Dengue fever virus infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To evaluate the safety and tolerability of subcutaneously (SC) administered chimeric tetravalent dengue vaccine in healthy adults and children. - To assess the immunogenicity of the vaccine against all 4 dengue serotypes in healthy adults and children. |
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E.2.2 | Secondary objectives of the trial |
- To measure vaccine viremia due to each of the 4 dengue vaccine components after each dose (Part 1) - To evaluate the immune response induced by TDV in a population with previous exposure to dengue - To assess the levels of neutralizing antibodies against each of the 4 dengue serotypes after a single immunization - To assess the safety and immunogenicity of TDV at intervals during long term follow up (up to 36 months post-first dose) - To evaluate possible efficacy in terms of reduction of disease incidence. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male or female at least 1.5 years and ≤45 years old at time of screening. 2. In good health as determined by medical history, physical examination including height and weight. 3. Normal safety laboratory values at screening. 4. Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies & Hepatitis B surface antigen. 5. Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception. 6. Weight: Within 1.3 times of the upper limit of local normal age-adjusted body mass index (BMI). |
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E.4 | Principal exclusion criteria |
1. For participants ≥12 years, clinically significant electrocardiogram (ECG) findings. 2. History of significant dermatologic (skin) disease within last 6 months. 3. History of diabetes mellitus. 4. History of thymic pathology, thymectomy, myasthenia or any immunodeficiency. 5. History of recurring headaches or migraines. 6. Hypersensitivity to any vaccine. 7. For participants ≥12 years, positive urine screen for cocaine, amphetamines, opiates, or cannabinoids. 8. History of alcohol abuse. 9. Pregnant or lactating female. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity 2. Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity 3. Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity 4. Number of Participants With Any Solicited AE Following Either Vaccination Dose 5. Number of Participants With at Least One Unsolicited AE Following Either Vaccination Dose by Severity 6. Seropositivity Rate to Each of the Four Dengue Serotypes at Day 120 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination 2. Part I: Duration of Vaccine Viremia 3. Part I: Titers of Vaccine Viremia 4. Seropositivity Rate to Each of the Four Dengue Serotypes 5. Seroconversion Rate to Each of the Four Dengue Serotypes 6. Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes 7. Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes 8. Number of Participants With Confirmed Dengue Fever |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Tolerability Immunogenicity |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 10 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
Colombia |
Puerto Rico |
Singapore |
Thailand |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 5 |