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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
212
TDV SC injection.
Placebo SC injection.
Clinica de la Costa Ltda
Barranquilla, Atlántico, Colombia
NOT_YET_RECRUITINGCentro de Estudios en Infectologia Pediatrica S.A.S
Cali, Valle del Cauca Department, Colombia
NOT_YET_RECRUITINGKing Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, Thailand
NOT_YET_RECRUITINGThammasat University Hospital
Khlong Luang, Changwat Pathum Thani, Thailand
RECRUITINGPercentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1 (Overall and by Severity)
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 of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time frame: Within 7 Days post-vaccination at Day 1
Percentage of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 90 (Overall and by Severity)
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 of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time frame: Within 7 days post-vaccination at Day 90
Percentage of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 (Overall and by Severity)
Solicited systemic AEs include fever (body temperature greater than or equal to \[\>=\] 38-degree Celsius \[C\], drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time frame: Within 14 days post-vaccination at Day 1
Percentage of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90 (Overall and by Severity)
Solicited systemic AEs include fever (body temperature \>= 38 degree (C), drowsiness, irritability/fussiness and loss of appetite. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Time frame: Within 14 days post-vaccination at Day 90
Percentage of Participants with Unsolicited AEs Within 28 Days Post Vaccination at Day 1
An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day IMP administration).
Time frame: Within 28 days post-vaccination at Day 1
Percentage of Participants with Unsolicited AEs Within 28 Days Post Vaccination at Day 90
An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day of IMP administration).
Time frame: Within 28 days post-vaccination at Day 90
Percentage of Participants with Medically-attended AEs (MAAEs)
MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department (medically attended visits), but not fulfilling seriousness criteria.
Time frame: From Day 1 through the end of trial (up to Day 1170)
Percentage of Participants with Serious Adverse Events (SAEs)
SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above-mentioned criteria.
Time frame: From Day 1 through the end of trial (up to Day 1170)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of 4 Dengue Virus Serotypes at Day 120
GMTs of neutralizing antibodies will be measured by MNT against 4 dengue virus serotypes. The 4 dengue virus serotypes are dengue virus (DENV-1, DENV-2, DENV-3 and DENV-4) will be reported.
Time frame: Day 120
GMTs of Neutralizing Antibodies by MNT for Each of the 4 Dengue Virus Serotypes
GMTs of neutralizing antibodies will be measured by MNT against 4 dengue virus serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: Day 1, Day 30, Day 270, Day 450, Day 810 and Day 1170
Seropositivity Rates for 4 Dengue Virus Serotypes
Seropositive rate is defined the percentage of participants with MNT titer \>=10 against each of the four dengue virus serotypes. The four dengue virus serotypes (DENV-1, DENV-2, DENV-3 and DENV-4) will be reported.
Time frame: Day 1, Day 30, Day 120, Day 270, Day 450, Day 810 and Day 1170
Seropositivity Rates For Multiple (2, 3, or 4) Dengue Virus Serotypes
Seropositive rate is defined the percentage of participants with MNT titer \>=10 against multiple (2, 3, or 4) dengue virus serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Time frame: Day 1, Day 30, Day 120, Day 270, Day 450, Day 810 and Day 1170
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