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.
Who can participate
Age range45 Years – 79 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Participant can comply with trial procedures and is available for the duration of follow-up.
Exclusion criteria
✕. 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.
What they're measuring
1
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1
Timeframe: Within 7 days post-vaccination at Day 1
2
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 90
Timeframe: Within 7 days post-vaccination at Day 90
3
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1
Timeframe: Within 14 days post-vaccination at Day 1
4
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90
Timeframe: Within 14 days post-vaccination at Day 90
5
Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 Days Post Vaccination at Day 1
Timeframe: Within 7 days post-vaccination at Day 1
6
Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 Days Post Vaccination at Day 90
Timeframe: Within 7 days post-vaccination at Day 90
7
Percentage of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1
✕. 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).
✕. Participant has an illness, or history of any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participant due to involvement in this trial.
✕. Participant has a known or suspected altered immunocompetence, including:
✕. Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example, greater than or equal to \[\>=\] 2 milligram per kilogram \[mg/kg\] body weight prednisone \[or equivalent\] for \>=14 consecutive days, or \>=20 milligram per day \[mg/day\] prednisone \[or equivalent\] administered for \>=14 consecutive days) within 60 days prior to Day 1 (month \[M0\]) (note: use of corticosteroids by inhaled, intranasal, intra-articular, bursal, tendon injection, or topical routes is allowed).
✕. Receipt of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
Timeframe: Within 14 days post-vaccination at Day 1
8
Percentage of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 90
Timeframe: Within 14 days post-vaccination at Day 90
9
Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 1
Timeframe: Within 28 days post-vaccination at Day 1
10
Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 90
Timeframe: Within 28 days post-vaccination at Day 90
11
Percentage of Participants with a Serious Adverse Event (SAE)
Timeframe: From first vaccination on Day 1 through the end of trial (up to Day 270)
12
Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of the 4 Dengue Virus Serotypes at Day 120