Dengue fever MedDRA version: 20.1 Level: LLT Classification code 10012312 Term: Dengue fever virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Qdenga®
Product Name: Dengue Tetravalent Vaccine (TDV) (Live, Attenuated)
Product Code: TAK-003
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Deng
Sponsors
Takeda
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is aged greater than or equal to (>=) 4 to less than or equal to (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Has contraindications, warnings and/or precautions applicable to vaccination with TDV as specified in investigator brochure (IB). 2.Has known hypersensitivity or allergy to any of IMP components (including excipients of IMP). 3.Has behavioral or cognitive impairment or psychiatric disease that, in opinion of investigator, may interfere with subject's ability to participate in trial. 4.Has history of progressive or severe neurologic disorder, seizure disorder or neuroinflammatory disease (example, Guillain-Barré syndrome). 5.Has clinically significant active infection (as assessed by the investigator) or body temperature greater than (>) 38.0 degree Celsius (>100.4 degree Fahrenheit) within 3 days of intended investigational medicinal product (IMP) administration on Day 1 (M0). 6.Has an illness, or history of any illness that, in opinion of investigator, might interfere with results of trial or pose additional risk to subject due to involvement in this trial. 7.Has known or suspected impairment/alteration of immune function, including: a.Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example,>=2 milligram per kilogram (mg/kg) body weight/day prednisone/prednisolone [or equivalent] for >=14 consecutive days, or, >=20 mg/day prednisone/prednisolone [or equivalent] for >=14 consecutive days) within 60 days prior to Day 1 (M0) b.Receipt of blood, immunoglobulins, blood products, and/or plasma derivatives within 90 days prior to Day 1 (M0) c.Receipt of immunostimulants within 60 days prior to Day 1 (M0) d.Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0) e.Reported or known symptomatic HIV infection or asymptomatic HIV infection when accompanied by evidence of impaired immune function f.Reported or known Hepatitis B and/or Hepatitis C virus infection g.Genetic immunodeficiency 8.Has known or suspected abnormalities of splenic or thymic function. 9.Has known bleeding diathesis or any condition that may be associated with prolonged bleeding time. 10.Has serious chronic or progressive disease deemed to be preclusive to trial entry, that is, not medically stable according to judgment of investigator. 11.Subject is participating in any clinical trial with another investigational product within 30 days prior to Day 1 (M0) or plans to participate in another clinical trial at any time during conduct of this trial. 12.Has previously received a vaccination against flavivirus other than Japanese encephalitis (JE) (investigational or licensed). 13.Who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (M0) or who are planning to receive any vaccine other than IMP within 28 days of IMP administration. 14.Who received coronavirus vaccine within 14 days prior to Day 1 (M0). 15.Who received vaccine authorized for emergency use within 28 days prior to Day 1 (M0). 16.Who received any JE vaccines within 28 days prior to Day 1 (M0) or who are planning to receive any JE vaccines during the trial period. 17.Previous participation in any clinical trial of dengue or other flavivirus candidate vaccine, except for subjects who received placebo in those trials. 18.Subject with body mass index (BMI) greater than or equal to 35 kg/m^2 (=weight in kg/[height in square meters]) on Day 1 (M0). 19.Who intends to travel to dengue endemic areas during trial period. 20.Subject with do
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immunogenicity of TDV administered as 2 doses given 3 months apart in healthy adults, adolescents, and children at 1 month post second dose.;Secondary Objective: •To describe the immunogenicity of TDV in healthy adults, adolescents, and children at other specified timepoints. •To assess the safety profile of TDV administered as 2 doses given 3 months apart in healthy adults, adolescents, and children. ;Primary end point(s): 1. Percentage of Seropositive Subjects for Each of the 4 Dengue Virus Serotypes ;Timepoint(s) of evaluation of this end point: At Day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of Seropositive Subjects for Each of the 4 Dengue Virus Serotypes 2. Geometric Mean Titers (GMT) of Neutralizing Antibodies by Microneutralization Test (MNT) For Each of the 4 Dengue Serotypes 3. Percentage of Seropositive Subjects for Multiple (2, 3, or 4) Dengue Virus Serotypes 4. Number of Subjects with Solicited Local (Injection Site) Adverse Events (AEs) 5. Number of Subjects with Solicited Local (Injection Site) AEs by Severity 6.Number of Subjects with Solicited Systemic AEs 7. Number of Subjects with Solicited Systemic AEs by Severity 8. Percentage of Subjects with any Unsolicited AEs 9. Percentage of Subjects with Serious Adverse Event (SAE) 10. Percentage of Subjects with Medically Attended AEs (MAAEs);Timepoint(s) of evaluation of this end point: Day 1, Day 30, Day 90 and Day 270 (For Percentage of Seropositive Subjects for Each of the 4 Dengue Virus Serotypes); Day 1, Day 30, Day 90, Day 120 and Day 270 (For GMT of Neutralizing Antibodies and Percentage of Seropositive Subjects for Multiple [2, 3, or 4] Dengue Virus Serotypes); For 7 days post-vaccination at Day 1 and Day 90 for Solicited Local AEs and Solicited Local AEs by Severity; For 14 days post-vaccination at Day 1 and Day 90 for Solicited Systemic AEs and Solicited Systemic AEs by Severity; For 28 days Post-vaccination at Day 1 and Day 90 for Unsolicited AEs; From vaccination (Day 1) to End of Trial (Day 270) for SAEs and MAAEs | — |
Countries
Japan
Contacts
Public ContactStudy Director
Takeda
Outcome results
None listed