Healthy Volunteers
Conditions
Keywords
Drug Therapy
Brief summary
The main aims of the study are to learn about side effects and a participant's immune response to Takeda's Dengue Vaccine when given twice within 3 months. Participants will receive 2 doses of their randomized treatment (vaccine or placebo). Children, teenagers and adults will receive one dose of either the vaccine or placebo on Day 1 and the second dose of either the vaccine or placebo 3 months later. Up to 4 blood samples will be taken throughout the study. During the study, participants will visit their study clinic 6 times.
Detailed description
The vaccine being tested in this study is called TDV (Live, Attenuated). TDV is being tested to prevent dengue. This study will assess the safety and immunogenicity of TDV in healthy participants. The study will enroll approximately 480 patients. Participants will be randomly assigned (by chance, like flipping a coin) to receive either TDV or placebo- which will remain undisclosed to the participant, and investigator during the study: * Cohort 1, ≥18 to ≤60 Age Group: TDV * Cohort 1, ≥18 to ≤60 Age Group: Placebo * Cohort 2, ≥4 to \<18 Age Group: TDV * Cohort 2, ≥4 to \<18 Age Group: Placebo This multi-center trial will be conducted in India. The overall duration of the study is approximately 9 months.
Interventions
BIOLOGICALTDV
TDV SC injection on Day 1 and Day 90 of the study
BIOLOGICALPlacebo
Normal Saline (0.9% NaCl) SC injection on Day 1 and Day 90 of the study
Sponsors
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1\. Participants who can comply with trial procedures and are available for the duration of follow-up. Key
Exclusion criteria
At screening and at vaccination: 1. A body mass index (BMI) ≥35 kg/m\^2. 2. Intent to participate in another clinical trial at any time during the conduct of this trial. 3. Plans to receive any of the following: 1. A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration. 2. A coronavirus vaccine within 14 days prior to TDV or placebo administration. 3. A vaccine authorized for emergency use within 28 days of TDV or placebo administration. 4. Known substance or alcohol abuse within the past 2 years that may interfere with his/her ability to comply with requirements for trial participation. 5. Receipt of previous vaccination against dengue virus. 6. Previous participation in any clinical trial of a dengue candidate vaccine. At Vaccination: 1. Participants with febrile illness or moderate or severe acute illness, or infection, at the time of random assignment. 2. Participants medicated with antipyretic and/or analgesic medication(s) within 24 hours prior to TDV or placebo administration. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years | Within 7 days post-vaccination at Day 1 | Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (\<6 years of age). |
| Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over | Within 7 days post-vaccination at Day 1 | Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age). |
| Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years | Within 7 days post-vaccination at Day 90 | Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for infant/toddler/child (\<6 years of age). |
| Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group 6 Years and Over | Within 7 days post-vaccination at Day 90 | Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe based on solicited safety parameters defined for child/adolescent/adult (≥6 years of age). |
| Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years | Within 14 days post-vaccination at Day 1 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children \<6 years old comprised: irritability/fussiness, drowsiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated). |
| Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 1 for Age Group 6 Years and Over | Within 14 days post-vaccination at Day 1 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated). |
| Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years | Within 14 days post-vaccination at Day 90 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children \<6 years old comprised: drowsiness, irritability/fussiness, loss of appetite (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe). Data for drowsiness, irritability/fussiness and loss of appetite has been reported in this outcome measure. |
| Number of Participants With Solicited Systemic AEs of Fever by Severity Within 14 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years | Within 14 days post-vaccination at Day 90 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children \<6 years old also comprised of fever in °C (collected by temperature ranges as indicated). Data for fever has been reported in this outcome measure. |
| Number of Participants With Solicited Systemic AEs by Severity Within 14 Days Post-vaccination at Day 90 for Age Group 6 Years and Over | Within 14 days post-vaccination at Day 90 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia (graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe) and fever in °C (collected by temperature ranges as indicated). |
| Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 1 | Within 28 days post-vaccination at Day 1 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. |
| Percentage of Participants With Any Unsolicited AEs Within 28 Days Post-vaccination at Day 90 | Within 28 days post-vaccination at Day 90 | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. |
| Percentage of Participants With an AE Leading to Participant Withdrawal From Trial | From first vaccination on Day 1 through the end of trial (up to Day 270) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. |
| Percentage of Participants With an AE Leading to TDV or Placebo Discontinuation | From first vaccination on Day 1 through the end of trial (up to Day 270) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. |
| Percentage of Participants With a Medically-attended AE (MAAE) | From first vaccination on Day 1 through the end of trial (up to Day 270) | MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department but not fulfilling seriousness criteria. |
| Percentage of Participants With a Serious Adverse Event (SAE) | From first vaccination on Day 1 through the end of trial (up to Day 270) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event. |
| GMTs of Neutralizing Antibodies by Microneutralization Test (MNT50) for Each of the 4 Dengue Virus Serotypes at Day 120 | Day 120 (Month 4) | GMTs of neutralizing antibodies were measured by microneutralization test 50% (MNT50) for each of the 4 dengue serotypes for all participants. The 4 dengue virus serotypes (DENV) are DENV-1, DENV-2, DENV-3 and DENV-4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GMTs by MNT50 Against Each of the 4 Dengue Virus Serotypes at Day 1 and Day 270 | Day 1 and 270 | GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 dengue serotypes for all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. |
| Percentage of Participants With Seroconversion for Each of the 4 Dengue Virus Serotypes | Day 1, Day 120 and Day 270 | Seroconversion rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositive is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. |
| Percentage of Participants With Seroconversion for Multiple (2, 3, or 4) Dengue Virus Serotypes | Day 1, Day 120 and Day 270 | Seroconversion rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositive is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. |
Countries
India
Contacts
STUDY_DIRECTORMedical Director
Takeda
Participant flow
Recruitment details
Participants took part in the study at 10 investigative sites in India from 29 March 2024 to 05 May 2025.
Pre-assignment details
Healthy children and adult participants were enrolled in the study in Cohort 1 (greater than or equal to \[≥\]18 to less than or equal to \[≤\]60 Years Age Group) and Cohort 2 (≥4 to less than \[\<\]18 Years Age Group) to receive either Dengue Tetravalent Vaccine (TDV) or placebo in a 3:1 ratio.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 23.4 years STANDARD_DEVIATION 16.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 180 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 176 Participants |
| Sex: Female, Male Male | 126 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 180 | 0 / 60 | 0 / 180 | 0 / 60 |
| other Total, other adverse events | 53 / 180 | 19 / 60 | 52 / 180 | 15 / 60 |
| serious Total, serious adverse events | 0 / 180 | 0 / 60 | 0 / 180 | 0 / 60 |
Outcome results
None listed