Phase 2 N=360 Randomized Quadruple-blind Prevention

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

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01511250 ↗

Enrolled (actual)

360

Serious AEs

8.1%

Results posted

Mar 2018

Primary outcome: Primary: Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity — 7; 0; 14; 3 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: TDV (Biological); Placebo (Biological)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: Takeda
Primary completion: Apr 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity	7; 0; 14; 3; 9; 0	—
PRIMARY Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) (In Clinic Assessment) Following Either Vaccination Dose by Severity	2; 0; 4; 2; 9; 5	—
PRIMARY Number of Participants With Solicited Systemic Adverse Events (AEs) (Diary-Recorded) Following Either Vaccination Dose by Severity	1; 3; 4; 1; 1; 1	—
PRIMARY Number of Participants With Any Solicited AE Following Either Vaccination Dose	13; 9; 17; 12; 12; 8	—
PRIMARY Number of Participants With at Least One Unsolicited AE Following Either Vaccination Dose by Severity	13; 7; 14; 8; 12; 11	—
PRIMARY Seropositivity Rate to Each of the Four Dengue Serotypes at Day 120	100.0; 92.3; 100.0; 85.7; 100.0; 23.5	—
SECONDARY Part I: Number of Participants Positive for Vaccine Viremia for Each of Four Vaccine Strain Serotypes After the Each Vaccination	0; 0; 0; 0; 0; 0	—
SECONDARY Part I: Duration of Vaccine Viremia	—	—
SECONDARY Part I: Titers of Vaccine Viremia	—	—
SECONDARY Seropositivity Rate to Each of the Four Dengue Serotypes	100.0; 92.3; 86.4; 85.7; 100.0; 23.5	—
SECONDARY Seroconversion Rate to Each of the Four Dengue Serotypes	45.8; 7.7; 63.6; 0.0; 90.5; 5.9	—
SECONDARY Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes	1156.9; 396.1; 919.5; 204.9; 383.7; 11.3	—
SECONDARY Geometric Mean Fold Rise (GMFR) of Dengue Neutralizing Antibody Titers for Each of the 4 Dengue Serotypes	3.41; 0.90; 8.93; 1.03; 29.47; 1.00	—
SECONDARY Number of Participants With Confirmed Dengue Fever	0; 0; 1; 0; 1; 0	—

Summary

The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine (TDV) (previously DENVax) administered subcutaneously in healthy adults and children. In addition the antibody response to the four dengue virus serotypes will be evaluated.

Eligibility Criteria

Inclusion Criteria

In good health as determined by medical history, physical examination including height and weight
Normal safety laboratory values at screening
Negative for human immunodeficiency virus-1 (HIV-1) antibodies, Hepatitis C antibodies & Hepatitis B surface antigen
Females negative by urine pregnancy test at screening and immediately prior to injection, and were willing to use reliable means of contraception
Weight: Within 1.3 times of the upper limit of local normal age-adjusted body mass index (BMI)

Exclusion Criteria

For participants ≥12 years, clinically significant electrocardiogram (ECG) findings
History of significant dermatologic (skin) disease within last 6 months
History of diabetes mellitus
History of thymic pathology, thymectomy, myasthenia or any immunodeficiency
History of recurring headaches or migraines
Hypersensitivity to any vaccine
For participants ≥12 years, positive urine screen for cocaine, amphetamines, opiates, or cannabinoids
History of alcohol abuse
Pregnant or lactating female

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01511250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.