Healthy VolunteersPhase 3TIDESNCT02747927
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
A Phase 3 study testing Tetravalent Dengue Vaccine (TDV) in people with Healthy Volunteers, run by Takeda at 28 sites in 8 countries.
Trial summary
The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants. Read more about this study
- Who is it for?
- Ages 4 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Tetravalent Dengue Vaccine (TDV)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20,099 participants
- Where
- 28 sitesin 8 countries
- Study dates
- 26 Apr 2016to 28 Jun 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Is aged 4 to 16 years, inclusive, at the time of randomization.
- Is in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the Investigator.
- The participant and/or the participant's parent/guardian signs and dates an assent/written informed consent form where applicable, and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to local regulatory requirements.
- Can comply with trial procedures and are available for the duration of follow-up.
- Is included in the per-protocol set (PPS) of the trial.
- Was aged 4 to 11 years at the time of randomization in the study (Day 1 [Month 0]).
Who cannot join
- Has febrile illness (temperature ≥38°C) or moderate or severe acute illness or infection at the time of randomization.
- Has history of or any illness that, in the opinion of the Investigator, might interfere with the results of the trial or pose an additional risk to the participant due to participation in the trial.
- Has received any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1 (Month 0) or planning to receive any vaccine within 28 days after Day 1 (Month 0).
- Has participated in any clinical trial with another investigational product 30 days prior to Day 1 (Month 0) or intent to participate in another clinical trial at any time during the conduct of this trial.
- Has previously participated in any clinical trial of a dengue candidate vaccine, or previous receipt of a dengue vaccine.
- Is first degree relative of individuals involved in trial conduct.
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- Females of childbearing potential who are sexually active, and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (Month 0).
- Females of childbearing potential who are sexually active, and who refuse to use an acceptable contraceptive method up to 6 weeks post-second vaccination.
- Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
- Identified as an employee of the Investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that Investigator or trial center.
- Receipt of any other vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to Day 1b (Month 0b), or planning to receive any vaccine within 28 days after Day 1b (Month 0b).
- Participation in any clinical trial with another investigational product at any time during participation in this trial or intent to participate in another clinical trial at any time during the conduct of the booster phase of this trial.
Trial locations and contacts
28 sites in 8 countries.
28 sites in 8 countries
Philippines6 sites
Philippines-AFRIMS Virology Research Unit
Cebu City, Cebu, 6000
Research Institute for Tropical Medicine
City of Muntinlupa, 1781
Dela Salle Health Sciences Institute
Dasmariñas, Cavite, 4114
University of the Philippine Manila
Ermita, 1000
Las Pinas Health Center A
Las Piñas
Las Pinas Health Center D
Las Piñas
Brazil4 sites
Universidade Federal de Mato Grosso do Sul
Campo Grande, Mato Grosso do Sul, 79070-900
Centro de Estudos e Pesquisa em Molestias Infecciosas LTDA (CPCLIN)
Cidade Alta, Natal - RN, 59025-050
Associacao Obras Sociais Irma Dulce Hospital Santo Antonio
Salvador, Estado de Bahia, 40415-000
Universidade Federal Do Espirito Santo Hospital Universitario Cassiano Antonio de Moraes HUCAM
Vitória, Espírito Santo, 29040-091
Colombia4 sites
Centro de Atencion e Investigacion Medica S.A. - CAIMED - Acacias - PPDS-PV
Acacías, Meta Department, 507001
Centro de Atencion e Investigacion Medica S.A - CAIMED - Aguazul - PPDS-PV
Aguazul, Casanare Department
Centro de Estudios em Infectologia Pediatrica SAS (CEIP S.A.S)
Cali, San Fernando
Centro de Atencion e Investigacion Medica S.A - CAIMED - Yopal - PPDS-PV
Yopal, Casanare Department
Panama4 sites
Centro De Vacunacion Internacional, S.A. (Cevaxin)
Panama City, 10662
Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede 24 de Diciembre
Panama City
Centro De Vacunacion Internacional, S.A. (Cevaxin) Sede Plaza Carolina
Panama City
Centro De Vacunacion Internacional, S.A.(Cevaxin) - La Chorrera
Panama City
Sri Lanka4 sites
Lady Ridgeway Hospital for Children
Colombo, 00800
Colombo South Teaching Hospital
Dehiwala, 10250
Negombo General Hospital
Negombo, 11500
Colombo North Teaching Hospital
Ragama, 11010
Thailand3 sites
The Hospital for Tropical Diseases
Bangkok, Bangkok, 10270
Phramongkutklao Hospital
Bangkok, Bangkok, 10400
Srinagarind Hospital
Khon Kaen, 40002
Dominican Republic2 sites
Hospital Maternidad Nuestra Senora de Altagracia
Santo Domingo, Distrito Nacional Santo Domingo, 10204
Calle Alexander Fleming No. 90 Esquina 37, Ensanche La Fe
Santo Domingo, Distrito Nacional Santo Domingo, 10514
Nicaragua1 site
Universidad Nacional Autonoma de Nicaragua
León
About this study
Official title: Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Investigate the Efficacy, Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TDV) Administered Subcutaneously in Healthy Children Aged 4 - 16 Years Old
The main purpose of this study is to evaluate the efficacy of 2 doses of Tetravalent Dengue Vaccine Candidate (TDV) in preventing symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in 4 to 16 year old participants.
Read the detailed description
The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). TDV is being tested to protect people against dengue fever and to look at long-term safety results. This study will look at the success rate of TDV in preventing dengue fever (vaccine efficacy) and long-term side effects of the vaccine.
The study will be conducted in 5 parts. Part 1 will evaluate vaccine efficacy (VE) and will last a minimum of 15 months. Part 2 will be for an additional 6 months to evaluate VE. Part 3 will evaluate long-term safety by following participants for side effects and will last an additional 3 years. Part 4 will evaluate safety for 13 months post-booster vaccination. Part 5 will be the long-term safety follow-up for 1 year after completion of Part 4. Participants may be enrolled into a dry-run to commence and test febrile surveillance methodology; this dry-run part may be up to 10 months prior to receiving study injection, however, will not be applicable to all trials sites or participants.
Approximately 20,100 participants will be enrolled into the study and randomly assigned (by chance) to one of the two treatment groups-which will remain undisclosed to the participants and study doctors during the study (unless there is an urgent medical need):
- TDV 0.5 mL subcutaneous injection
- Placebo (dummy inactive subcutaneous injection) - this is a solution that looks like the study drug but has no active ingredient
All participants will receive a single injection of TDV or placebo on Day 1, Day 90. Participation in a booster phase will be offered to approximately 10,500 participants to receive (TDV or placebo) on Day 1b (Day 1 in booster phase). A subset of participants will be asked to record any local symptoms at the injection site (Pain, Erythema and Swelling) in a diary card for 7 days after each injection. The same subset of participants will also be asked to record any systemic symptoms (child <6 years: fever, irritability/fussiness, drowsiness, loss of appetite and child ≥6 years: fever, headache, asthenia, malaise and myalgia) in a diary card for 14 days after each injection.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 7 years excluding the dry-run. Participants will make multiple visits to the clinic and will be contacted at least every week for the entire study duration.
- Conditions
- Healthy Volunteers
- Being tested
- Placebo, Tetravalent Dengue Vaccine (TDV)
- Keywords
- Drug therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
TDV placebo-matching SC injection.
Tetravalent Dengue Vaccine (TDV)Biological
TDV SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received placebo-matching TDV, 0.5 milliliters (mL), subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received placebo matching TDV, SC injection on Day 1 booster [b] (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study. Receives: Drug: Placebo |
| Tetravalent Dengue Vaccine (TDV) 0.5 mL | Experimental | Participants received TDV, 0.5 mL, SC injection on Day 1 (Month 0) and Day 90 (Month 3) in Part 1 of the study. Participants eligible for Booster Phase received TDV, SC injection on Day 1b (Month 0b) in Part 4 of the study based on the randomization code applied in Part 1 of the study. Receives: Biological: Tetravalent Dengue Vaccine (TDV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Efficacy (VE) of Two Doses of Tetravalent Dengue Vaccine Candidate (TDV) in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
The VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific reverse transcriptase polymerase chain reaction (RT-PCR). The primary endpoint of VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1.
Measured: 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 1 (Month 15) when at least 120 cases of dengue fever were confirmed and minimum duration of participant follow-up was 12 months post-second vaccination
Secondary outcomes (13)
VE of Two Doses of TDV in Preventing Hospitalization Due to Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of cases requiring hospitalization due to virologically-confirmed dengue fever that occurred during Part 1 and Part 2.
Measured: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Each Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2.
Measured: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seronegative at Baseline
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2.
Measured: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
VE of Two Doses of TDV in Preventing Virologically-Confirmed Dengue Fever Induced by Any Dengue Serotype in Participants Dengue Seropositive at Baseline
VE is defined as 1 - (λv/λC), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. VE was assessed using the number of virologically-confirmed dengue fever cases that occurred during Part 1 and Part 2.
Measured: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
VE of Two Doses of TDV in Preventing Virologically-Confirmed Severe Dengue Fever Induced by Any Dengue Serotype
VE is defined as 1 - (λv/λc), where λv and λc denote the hazard rates for the TDV and placebo arms, respectively. A virologically-confirmed dengue case is defined as febrile illness (defined as temperature ≥38°C on any 2 of 3 consecutive days) or illness clinically suspected to be dengue by the Investigator with a positive serotype-specific RT-PCR. Severe cases were determined by Adjudication Committee. VE was assessed using the number of severe cases due to virologically-confirmed dengue fever that occurred during Part 1 and Part 2.
Measured: From 30 days post-second vaccination (Day 120 [Month 4]) until the end of Part 2 (Month 21)
Percentage of Participants With Solicited Local Injection Site Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except erythema and swelling) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for erythema and swelling were derived from the recorded diameters. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Measured: Days 1 through 7 after each vaccination
Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity in the Safety Set Immunogenicity Subset
Solicited systemic AEs in children (< 6 years) are defined as fever, irritability/fussiness, drowsiness and loss of appetite that occurred within 14 days after each vaccination. Solicited systemic AEs in children (≥ 6 years) are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days after each vaccination. The participant/legal guardian recorded the severity of each AE (except fever) according to the diary card instruction as none, mild, moderate, or severe. Severity grades for fever were derived from the recorded body temperature measurements and presented using the proposed temperature increments published by the Brighton Collaboration. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Measured: Days 1 through 14 after each vaccination on Day 1 (Month 0) and Day 90 (Month 3)
Percentage of Participants With Any Unsolicited Adverse Events (AEs) in the Safety Set Immunogenicity Subset
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study. Percentages were rounded off to the nearest single decimal place.
Measured: Days 1 through 28 after each vaccination on Day 1 (Month 0) and Day 90 (Month 3)
Percentage of Participants With Serious Adverse Events (SAEs) During Parts 1 and 2
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A serious adverse event (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. Percentages were rounded off to the nearest single decimal place. In the category 'Part 1 and 2 combined' participants are counted only once even if they experienced events in both Part 1 and Part 2 in order to yield total of unique participants who had SAEs.
Measured: From Day 1 until the end of Parts 1 (Month 15) and 2 (Month 21)
Percentage of Participants With Fatal SAEs and SAEs Related to Study Drug During the First and Second Half of Part 3
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine; it does not necessarily have to have a causal relationship with trial vaccine administration. A 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. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Measured: First and Second half (18 months each) of Part 3 (up to 3 years, beginning at Month 22)
Seropositivity Rate for Each of the Four Dengue Serotypes in the Immunogenicity Subset
Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Measured: Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)
Seropositivity Rate for Multiple Dengue Serotypes in the Immunogenicity Subset
Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for any one (monovalent), two (bivalent), three (trivalent), and four (tetravalent) dengue serotypes, as well as at least bivalent (seropositive for ≥2 dengue serotypes) and at least trivalent (seropositive for ≥3 dengue serotypes), is derived from the titers of dengue-neutralizing antibodies. Seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Percentages were rounded off to the nearest single decimal place except the data points where rounding-up may lead to data misinterpretation.
Measured: Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the Four Dengue Serotypes in the Immunogenicity Subset
GMTs of neutralizing antibodies were measured via microneutralization test 50% (MNT50). The four DENV serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Measured: Pre-vaccination on Day 1 (Baseline), post-first vaccination on Month 1, pre-vaccination on Month 3; post-second vaccination at Months 4, 9 and 15, and then annually (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start26 Apr 2016
- Primary completion11 Jul 2018
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20,099 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747927
- Sponsor's protocol ID
- DEN-301
- Other IDs
- U1111-1166-8401, PHRR150522-001010, 2018-003979-34, 2018
- Acronym
- TIDES
- Status last verified
- Nov 2025
- First submitted
- 14 Apr 2016
- Last updated
- 19 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Publications
Gottardo R, Dean H, Nascimento EJM, Tricou V, Sharma M. Beyond neutralization: A comprehensive framework for evaluating humoral immunity induced by a live-attenuated tetravalent dengue vaccine. Vaccine. 2026 Aug 13;88:128929. doi: 10.1016/j.vaccine.2026.128929. Epub 2026 Jul 21.
PubMed 42480195Pfaar H, Lopez-Medina E, Escudero I, Hutagalung Y, Roubinis N, Thakrar S, Corazon Borja-Tabora CF, Tricou V, Tuboi S. Operational challenges and lessons learned from conducting febrile surveillance in a long-term randomized dengue vaccine trial in Latin America and Asia-Pacific. Travel Med Infect Dis. 2025 May-Jun;65:102840. doi: 10.1016/j.tmaid.2025.102840. Epub 2025 Mar 20.
PubMed 40120920Rauscher M, Youard Z, Faccin A, Patel SS, Pang H, Zent O. Pregnancy outcomes following unintentional exposure to TAK-003, a live-attenuated tetravalent dengue vaccine. Expert Rev Vaccines. 2025 Dec;24(1):221-229. doi: 10.1080/14760584.2025.2480297. Epub 2025 Mar 27.
PubMed 40099800Fernando L, Kastner R, Wickramasinghe P, Fernando AD, Gunasekera D, Nguyen VH, Liu M, LeFevre I, Wallace D, Folschweiller N, Biswal S. Role of the dengue vaccine TAK-003 in an outbreak response: Modeling the Sri Lanka experience. PLoS Negl Trop Dis. 2024 Aug 22;18(8):e0012376. doi: 10.1371/journal.pntd.0012376. eCollection 2024 Aug.
PubMed 39173075Borja-Tabora C, Fernando L, Lopez Medina E, Reynales H, Rivera L, Saez-Llorens X, Sirivichayakul C, Yu D, Folschweiller N, Moss KJ, Rauscher M, Tricou V, Zhao Y, Biswal S. Immunogenicity, Safety, and Efficacy of a Tetravalent Dengue Vaccine in Children and Adolescents: An Analysis by Age Group. Clin Infect Dis. 2025 Feb 5;80(1):199-206. doi: 10.1093/cid/ciae369.
PubMed 38995684Sirivichayakul C, Biswal S, Saez-Llorens X, Lopez-Medina E, Borja-Tabora C, Bravo L, Kosalaraksa P, Alera MT, Reynales H, Rivera L, Watanaveeradej V, Yu D, Espinoza F, Dietze R, Fernando L, Wickramasinghe VP, Moreira ED Jr, Fernando AD, Gunasekera D, Luz K, Venancio da Cunha R, Oliveira AL, Rauscher M, Fan H, Borkowski A, Escudero I, Tuboi S, Lloyd E, Tricou V, Folschweiller N, LeFevre I, Vargas LM, Wallace D; TIDES Study Group. Efficacy and Safety of a Tetravalent Dengue Vaccine (TAK-003) in Children With Prior Japanese Encephalitis or Yellow Fever Vaccination. J Infect Dis. 2024 Dec 16;230(6):e1214-e1225. doi: 10.1093/infdis/jiae222.
PubMed 38682569Tricou V, Yu D, Reynales H, Biswal S, Saez-Llorens X, Sirivichayakul C, Lopez P, Borja-Tabora C, Bravo L, Kosalaraksa P, Vargas LM, Alera MT, Rivera L, Watanaveeradej V, Dietze R, Fernando L, Wickramasinghe VP, Moreira ED Jr, Fernando AD, Gunasekera D, Luz K, Oliveira AL, Tuboi S, Escudero I, Hutagalung Y, Lloyd E, Rauscher M, Zent O, Folschweiller N, LeFevre I, Espinoza F, Wallace D. Long-term efficacy and safety of a tetravalent dengue vaccine (TAK-003): 4.5-year results from a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Glob Health. 2024 Feb;12(2):e257-e270. doi: 10.1016/S2214-109X(23)00522-3.
PubMed 38245116Saez-Llorens X, Biswal S, Borja-Tabora C, Fernando L, Liu M, Wallace D, Folschweiller N, Reynales H, LeFevre I; TIDES Study Group. Effect of the Tetravalent Dengue Vaccine TAK-003 on Sequential Episodes of Symptomatic Dengue. Am J Trop Med Hyg. 2023 Mar 6;108(4):722-726. doi: 10.4269/ajtmh.22-0673. Print 2023 Apr 5.
PubMed 36878213Rivera L, Biswal S, Saez-Llorens X, Reynales H, Lopez-Medina E, Borja-Tabora C, Bravo L, Sirivichayakul C, Kosalaraksa P, Martinez Vargas L, Yu D, Watanaveeradej V, Espinoza F, Dietze R, Fernando L, Wickramasinghe P, Duarte MoreiraJr E, Fernando AD, Gunasekera D, Luz K, Venancioda Cunha R, Rauscher M, Zent O, Liu M, Hoffman E, LeFevre I, Tricou V, Wallace D, Alera M, Borkowski A. Three-year Efficacy and Safety of Takeda's Dengue Vaccine Candidate (TAK-003). Clin Infect Dis. 2022 Aug 24;75(1):107-117. doi: 10.1093/cid/ciab864.
PubMed 34606595Biswal S, Borja-Tabora C, Martinez Vargas L, Velasquez H, Theresa Alera M, Sierra V, Johana Rodriguez-Arenales E, Yu D, Wickramasinghe VP, Duarte Moreira E Jr, Fernando AD, Gunasekera D, Kosalaraksa P, Espinoza F, Lopez-Medina E, Bravo L, Tuboi S, Hutagalung Y, Garbes P, Escudero I, Rauscher M, Bizjajeva S, LeFevre I, Borkowski A, Saez-Llorens X, Wallace D; TIDES study group. Efficacy of a tetravalent dengue vaccine in healthy children aged 4-16 years: a randomised, placebo-controlled, phase 3 trial. Lancet. 2020 May 2;395(10234):1423-1433. doi: 10.1016/S0140-6736(20)30414-1. Epub 2020 Mar 17.
PubMed 32197105Biswal S, Reynales H, Saez-Llorens X, Lopez P, Borja-Tabora C, Kosalaraksa P, Sirivichayakul C, Watanaveeradej V, Rivera L, Espinoza F, Fernando L, Dietze R, Luz K, Venancio da Cunha R, Jimeno J, Lopez-Medina E, Borkowski A, Brose M, Rauscher M, LeFevre I, Bizjajeva S, Bravo L, Wallace D; TIDES Study Group. Efficacy of a Tetravalent Dengue Vaccine in Healthy Children and Adolescents. N Engl J Med. 2019 Nov 21;381(21):2009-2019. doi: 10.1056/NEJMoa1903869. Epub 2019 Nov 6.
PubMed 31693803