A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)
ConditionDengue Fever
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age45-79
SponsorTakeda
About this trial
Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition.
In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first).
During the study, participants will visit their study clinic 5 times.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant is aged 45 to 79 years at the time of entry into the trial.
Participant is male or female.
Participant is in good health or has a medical diagnosis of one or more of diabetes mellitus, hypertension, or chronic kidney disease (that is, comorbidities) and are medically stable in the opinion of the investigator at the time of entry into the trial, as determined by medical history and targeted physical examination. Medically stable is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to participating in the trial.
Participant has signed and dated a written informed consent form and any required privacy authorization prior to the initiation of any trial procedure, and after the nature of the trial has been explained according to local regulatory requirements.
Disqualifiers
Participant has contraindication(s), warning(s), and/or precaution(s) applicable to vaccination with TDV as specified in the Investigator's Brochure and/or approved product label (as applicable) in the participating country.
Participant has a known hypersensitivity or allergy to any of the TDV or placebo components (including excipients).
Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the participant's ability to take part in the trial.
Participant has a history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).
Trial design
Design model
Parallel
Treatments tested in this trial
TDV
Biological/VaccineTDV SC injection.
Placebo
Other interventionPlacebo SC injection.
Treatment groups
800 Participants
are divided into 3 treatment groupsGroup A: Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mLExperimental treatment 1 intervention
Group B: Cohort 1: PlaceboPlacebo comparator 1 intervention
Group C: Cohort 2: TDV 0.5 mLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medical product (IMP); it does not necessarily have to have a causal relationship with IMP administration. Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.
Time frame
Within 7 days post-vaccination at Day 12
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 90
Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.
Time frame
Within 7 days post-vaccination at Day 903
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1
Solicited systemic AEs include fever (body temperature greater than or equal to \[\>=\] 38 degree Celsius \[C\], asthenia, malaise, headache, and myalgia.
Time frame
Within 14 days post-vaccination at Day 14
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90
Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia.
Time frame
Within 14 days post-vaccination at Day 90Secondary outcomes
1
Number of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.
Time frame
Within 7 days post-vaccination at Day 1 and Day 902
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia.
Time frame
Within 14 days post-vaccination at Day 1 and Day 903
Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time frame
Within 7 days post-vaccination at Day 1 and Day 904
Percentage of Participants with Solicited Systemic AEs by Severity (With Comorbidities)
Solicited systemic AEs include fever (body temperature \>= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time frame
Within 14 days post-vaccination at Day 1 and Day 90 Source ClinicalTrials.gov