Phase 3
N=900
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) Administered With a Yellow Fever Vaccine in Adults
Dengue
Bottom Line
View on ClinicalTrials.gov: NCT03342898 ↗Enrolled (actual)
900
Serious AEs
3.3%
Results posted
Oct 2020
Primary outcome: Primary: Percentage of Participants Who Are YF and Dengue Virus (DENV)-Naive at Baseline and Are Seroprotected Against YF on Day 30 as Measured by Plaque Reduction Neutralization Test (PRNT) — 99.5; 9.8; 99.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- YF-17D (Biological); TDV (Biological); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Are YF and Dengue Virus (DENV)-Naive at Baseline and Are Seroprotected Against YF on Day 30 as Measured by Plaque Reduction Neutralization Test (PRNT) |
99.5; 9.8; 99.1 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline |
6.0; 226.2; 119.4; 7.7; 5431.1; 650.8 | — |
| SECONDARY Percentage of Participants Who Are Seropositive for Each of the 4 Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline |
6.5; 93.3; 87.6; 15.8; 95.9; 88.1 | — |
| SECONDARY Percentage of Participants Who Are Seropositive for Multiple (2, 3 or 4) Dengue Serotypes on Days 30, 90, 120, 180 and 210 in Participants YF and DENV-naive at Baseline |
5.4; 96.9; 90.8; 4.9; 91.7; 81.6 | — |
| SECONDARY Percentage of YF and DENV-naive Participants at Baseline Who Are Seroprotected Against YF on Day 210 as Measured by PRNT |
100.0; 98.4; 98.9 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Anti-YF Neutralizing Antibodies at Day 30 in Participants YF and DENV-Naive at Baseline |
4245.7; 6.0; 4321.7 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Anti-YF Neutralizing Antibodies at Day 210 in Participants YF and DENV-Naive at Baseline |
2341.6; 3078.2; 1089.1 | — |
| SECONDARY Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) Following Each Vaccination Dose by Severity |
13.1; 16.8; 27.3; 13.1; 44.2; 48.9 | — |
| SECONDARY Percentage of Participants With Solicited Systemic Adverse Events Following Each Vaccination Dose by Severity |
43.6; 49.8; 51.8; 31.8; 33.0; 39.9 | — |
| SECONDARY Percentage of Participants With Any Unsolicited Adverse Events (AEs) |
11.7; 17.3; 14.0; 8.8; 10.4; 9.1 | — |
| SECONDARY Percentage of Participants With Medically Attended Adverse Events (MAAEs) |
14.3; 15.3; 15.3 | — |
| SECONDARY Percentage of Participants With Serious Adverse Events (SAEs) |
4.3; 3.3; 2.3 | — |
Summary
The main purpose of this study is to assess the immunogenicity and safety of the concomitant and sequential administration of yellow fever (YF) vaccine and tetravalent dengue vaccine (TDV) in healthy participants aged 18 to 60 years living in country non-endemic for both dengue and YF.
Eligibility Criteria
Inclusion Criteria
- Is aged 18 to 60 years inclusive, at the time of randomization.
- 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.
Exclusion Criteria
- Has an elevated oral temperature ≥ 38°C (100.4°F) within 3 days of the intended date of vaccination.
- Has contraindications, warnings and/or precautions to vaccination with the YF-17D vaccine as specified within the product information (especially history of thymus dysfunction).
- Female participant who are pregnant or breastfeeding
- Has any history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (e.g., Guillain-Barre syndrome) or suspected impairment/alteration of immune function.
- Has body mass index (BMI) greater than or equal to 35 kg/m^2 (=weight in kg/[height in meters^2]).
- Is intent to travel to dengue or YF endemic countries during the trial period.
- Has received any other vaccines 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 non-trial vaccine within 28 days of trial vaccine administration.
- Has previous and planned vaccination (during the trial conduct), against any flavivirus including dengue, YF, Japanese encephalitis (JE) or tick-borne encephalitis viruses.
- Has previous participation in any clinical trial of a dengue or other flavivirus (e.g., West Nile [WN] virus) candidate vaccine, except for participants who received placebo in those trials.
- Has a current or previous infection with a flavivirus such as dengue, Zika, YF, JE, WN fever, or Saint Louis encephalitis viruses and participants with a history of prolonged (≥1 year) habitation in a dengue endemic area.
Data sourced from ClinicalTrials.gov (NCT03342898). 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.