A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers

Phase 3

Not yet recruiting

• Conditions: Dengue Fever
• Interventions: Other: Placebo; Biological: TDV

• Registration Number: NCT06665035
• Lead Sponsor: Takeda

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-29
• Study First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Study Start: 2025-04-30
• Primary Completion: 2030-03-03
• Study Completion: 2030-03-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Placebo (Age group: >=12 to <21 months)	Placebo	Participants with the age group \>= 12 to \< 21 months receive placebo (normal saline), SC injection, on Day 1 and Day 90.
Cohort 2: TDV 0.5 mL(Age group: >=6 to <12 months)	TDV	Participants with the age group \>=6 to \<12 months receive TDV, 0.5 mL SC injection, on Day 1 and Day 90.
Cohort 2: Placebo (Age group: >=6 to <12 months)	Placebo	Participants with the age group \>=6 to \<12 months receive placebo (normal saline), SC injection, on Day 1 and Day 90.
Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL (Age group: >=12 to <21 months)	TDV	Participants with the age group \>= 12 to \< 21 months receive TDV 0.5 mL subcutaneous (SC) injection, on Day 1 and Day 90.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1 (Overall and by Severity)	Within 7 Days post-vaccination at Day 1	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.
Percentage of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 90 (Overall and by Severity)	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. The AEs of severity will be graded by investigator as Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Percentage of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 (Overall and by Severity)	Within 14 days post-vaccination at Day 1	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.
Percentage of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90 (Overall and by Severity)	Within 14 days post-vaccination at Day 90	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.
Percentage of Participants with Unsolicited AEs Within 28 Days Post Vaccination at Day 1	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).
Percentage of Participants with Unsolicited AEs Within 28 Days Post Vaccination at Day 90	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).
Percentage of Participants with Medically-attended AEs (MAAEs)	From Day 1 through the end of trial (up to Day 1170)	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.
Percentage of Participants with Serious Adverse Events (SAEs)	From Day 1 through the end of trial (up to Day 1170)	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.
Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of 4 Dengue Virus Serotypes at Day 120	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.

Secondary Outcome Measures

Name	Time	Method
GMTs of Neutralizing Antibodies by MNT for Each of the 4 Dengue Virus Serotypes	Day 1, Day 30, Day 270, Day 450, Day 810 and Day 1170	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.
Seropositivity Rates for 4 Dengue Virus Serotypes	Day 1, Day 30, Day 120, Day 270, Day 450, Day 810 and Day 1170	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.
Seropositivity Rates For Multiple (2, 3, or 4) Dengue Virus Serotypes	Day 1, Day 30, Day 120, Day 270, Day 450, Day 810 and Day 1170	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.

Trial Locations

Locations (4)

Clinica de la Costa; 🇨🇴 Barranquilla, Atlantico, Colombia

Centro de Estudios en Infectología Pediátrica S.A.S - CEIP S.A.S; 🇨🇴 Cali, Valle Del Cauca, Colombia

Faculty of Medicine, Chulalongkorn University; 🇹🇭 Pathumwan, Bangkok, Thailand

Faculty of Medicine, Thammasat University; 🇹🇭 Khlong Luang, Pathum Thani, Thailand