Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years

Phase 1

• Conditions: Dengue Fever; MedDRA version: 20.1Level: LLTClassification code 10012312Term: Dengue fever virus infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2022-003455-33-Outside-EU/EEA
• Lead Sponsor: Takeda Vaccines, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-12-21
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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).
Are the trial subjects under 18? yes
Number of subjects for this age range: 309
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 51
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified