Dengue Fever MedDRA version: 20.1 Level: PT Classification code 10012310 Term: Dengue fever System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Qdenga
Product Name: Dengue Tetravalent Vaccine (Live, Attenuated)
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Dengue virus serotype 1 (live, at
Sponsors
Takeda
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants who can comply with trial procedures and are available for the duration of follow-up. Are the trial subjects under 18? yes Number of subjects for this age range: 240 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 260 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: At screening and at vaccination: 1. A body mass index (BMI) =35 kg/m^2. 2. Intent to participate in another clinical trial at any time during the conduct of this trial. 3. Plans to receive any of the following: 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. 4. Known substance or alcohol abuse within the past 2 years that may interfere with his/her ability to comply with requirements for trial participation. 5. Receipt of previous vaccination against dengue virus. 6. Previous participation in any clinical trial of a dengue candidate vaccine. At Vaccination: 1. Participants with febrile illness 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To assess the safety profile of Dengue Tetravalent Vaccine (TDV) administered as 2 doses given 3 months apart in healthy adults, adolescents, and children. • 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 dose.;Secondary Objective: • To describe immunogenicity of TDV at baseline and 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 second TDV dose, and 6 months post second TDV dose.;Primary end point(s): 1. Number of Participants With Solicited Local Adverse Events (AEs) by Severity 2. Number of Participants With Solicited Systemic AEs by Severity 3. Percentage of Participants With Any Unsolicited AEs 4. Percentage of Participants With an AE Leading to Participant Withdrawal 5. Percentage of Participants With an AE Leading to TDV or Placebo Discontinuation 6. Percentage of Participants With a Medically-attended AE (MAAE) 7. Percentage of Participants With a Serious Adverse Event (SAE) 8. Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Virus Serotypes;Timepoint(s) of evaluation of this end point: Postvaccination at Day 1 and Day 90 (up to 7 days for solicited local AEs, up to 14 days for solicited systemic AEs and up to 28 days for unsolicited AEs. From vaccination through 9 months for other AEs and Day 120 for GMTs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. GMTs for Each of the 4 Dengue Virus Serotypes 2. Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes 3. Percentage of Participants With Seroconversion for Multiple Dengue Virus Serotypes;Timepoint(s) of evaluation of this end point: Day 1, Day 120 and Day 270 | — |
Countries
India
Contacts
Public ContactStudy Director
Takeda
Outcome results
None listed