A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers
ConditionDengue Fever
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-20
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. The purpose of this study is to collect information of vaccination with TDV when given to children younger than 2 years. The main aims of this study are to learn how safe the vaccine is and how well it works to activate a young child's immune system (this is called immunogenicity). Children between the age of 6 and 21 months will receive two vaccinations with either TDV or placebo 3 months apart. Blood samples will be taken before and after the vaccination as well as throughout the study. These are necessary to check how well the vaccine works to activate the immune system. During the study, participants will visit their study clinic 8 times for vaccinations, blood draws and health checks.
Eligibility criteria
Qualifiers
Participant is aged >=6 to <21 months at the time of entry into the trial.
Participant is male or female.
Participant is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs), and the clinical judgment of the investigator.
Participant's legally acceptable representative (LAR) has signed and dated a written informed consent form (ICF) 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 (IB)and/or the approved product label (as applicable) in the participating country.
Participant has a known hypersensitivity or allergy to any of the investigational medicinal product (IMP) components (including excipients).
Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the participant's ability to participate 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
Treatments tested in this trial
- TDV
- Placebo
Treatment groups
212 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov