None listed
Conditions
Interventions
Intervention1: Lyophilised Tetravalent Dengue Vaccine and Diluent: Lyophilised Tetravalent Dengue Vaccine (TDV) for 0.5mL subcutaneous injection and
Diluent (37 mM NaCl solution) 1mL
Route: SC route
Pre-Vaccination Procedures (Day 1 [M0] and Day 90 [M3])
Vaccination Procedures (Day 1 [M0] and Day 90 [M3])
Post Vaccination Procedures (Day 1 [M0] and Day 90 [M3])
9.3.5 Site Visits after Vaccination (Day 30 [M1] and Day 120 [M4]) and Final (End of Trial) Visit (Day 270 [M9])
Control Intervention1: Placebo for 0.5mL subcutaneous injection Normal saline, NaCl 0.9
9.3.5 Site Visits after Vaccination (Day 30 [M1] and Day 120 [M4]) and Final (End of Trial) Visit (Day 270 [M9])
Sponsors
Takeda Vaccines, Inc.
IQVIA RDSIndia Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged =4 to =60 years at the time of random assignment. 2. Male or female. 3. Subjects in good health at the time of entry into the trial. 4. Subjects and/or the subjects legally acceptable representative (LAR) who have signed and dated a written, informed consent/pediatric assent form, and any required privacy authorization prior to the initiation of any trial procedures. 5. Subjects who can comply with trial procedures and are available for the duration of follow-up
Exclusion criteria
Exclusion criteria: 1. Subjects with any illness, or history of any illness that in the opinion of the investigator, might interfere with the results of the trial or pose an additional risk to the subject due to participation in the trial 2. Behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject’s ability to participate in the trial. 3. BMI =35 kg/m2 4. Intent to participate in another clinical trial at any time during the conduct of this trial 5. Subject plans to receive any of the following (consider whether applicable as an exclusion criterion or as a criterion for delay of Visit 1): a) A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration. b) A coronavirus vaccine within 14 days prior to TDV or placebo administration. c) A vaccine authorized for emergency use within 28 days of TDV or placebo administration. 6. Known substance or alcohol abuse within the past 2 years. 7. Pregnant subjects (ie, a positive or indeterminate pregnancy test) or breastfeeding. 8. Females of childbearing potential who are sexually active, and who: 1. have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1. 2. refuse to use an acceptable contraceptive method up to 6 weeks after the last dose of TDV or placebo. 9. Involved in the trial conduct or their first-degree relatives. 10. Subjects identified as an employee of the investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial center. 11. Receipt of previous vaccination against dengue virus. 12. Previous participation in any clinical trial of a dengue candidate vaccine, except if it is known that the subject received placebo while participating in those trials. Exclusion Criteria at Vaccination 1. Febrile illness (body temperature =38°C [=100.4°F]) or moderate or severe acute illness, or infection, at the time of random assignment 2. Medicated with antipyretic and/or analgesic medication(s) within 24 hours prior to TDV or placebo administration 3. Any new findings of illness in the interim period since screening Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety - To assess the safety profile of TDV administered as 2 doses given 3 months apart in healthy adults, adolescents, & children. Immunogenicity - To evaluate the immunogenicity of TDV administered as 2 doses given 3 months apart in healthy adults, adolescents, and children at 1 month post second doseTimepoint: Safety 3 months apart in healthy adults, adolescents, & children Immunogenicity 3 months apart in healthy adults, adolescents, & children at 1 month post second dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity - To describe immunogenicity of TDV at baseline & 6 months post second TDV dose when administered as 2 doses given 3 months apart. - To describe seropositivity (% of subjects with reciprocal neutralizing titer =10) at baseline, 1 month post TDV second dose & 6 months post second TDV dose.Timepoint: 3 months & 6 months post second TDV dose | — |
Countries
India
Contacts
Public ContactShweta Pradhan
IQVIA RDS (India) Private Limited
Outcome results
None listed