Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
997 participants
Study Classification
INTERVENTIONAL
Study Start Date
2026-01-31
Study Completion Date
2026-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This is a randomized, double-blind (60 -79 years) and open-label (40-59 years), three-arm parallel Phase 3b, multicenter study to evaluate the safety and non-inferiority of the humoral immune response of the Butantan Dengue vaccine (Dengue 1,2,3,4 (attenuated)) in participants aged 60 -79 years (elderly) compared to participants aged 40 to 59 years (adults), with or without previous dengue and healthy based on clinical examination.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluating the Safety and Immunogenicity of a Tetravalent Dengue Vaccine (TetraVax-DV) TV005 in Flavivirus-Naive Adults 50 to 70 Years of Age
NCT02879266
Dengue
COMPLETED
PHASE1
Phase II Trial to Evaluate Safety and Immunogenicity of a Dengue 1,2,3,4 (Attenuated) Vaccine
NCT01696422
Dengue
UNKNOWN
PHASE2
A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)
NCT06579755
Dengue Fever
RECRUITING
PHASE3
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-200,201) in Healthy Adults
NCT00270699
Dengue Fever
COMPLETED
PHASE1
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3-3'Ddelta30) in Healthy Adults
NCT00712803
Dengue
COMPLETED
PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study aims to evaluate the non-inferiority of the immune response induced by the Dengue 1,2,3,4 (attenuated) vaccine in participants aged 60 - 79 years old (elderly) compared to participants aged 40 to 59 years on Day 42 + 7 days after vaccination. The primary analysis will include the immunogenicity cohort (n=460 participants, allocated 1:1). The primary outcome is the proportion of neutralizing antibody seroconversion measured by plaque reduction neutralization test (PRNT50), for each dengue serotype, of participants aged 60 - 79 years (elderly) compared with participants aged 40 to 59 years (adults), with or without previous exposure to dengue, on Day 42 + 7 days after vaccination. The primary safety outcome will be the frequency and intensity of solicited and unsolicited adverse reactions from vaccination to Day 22 post-vaccination among participants aged 60 - 79 years and in participants aged 40 to 59 years, with or without prior exposure to dengue. The study will last one year in order to assess the duration of the immune response and serious adverse events (SAE) and events of special interest (SIAE). Throughout the study period, there will be surveillance of suspected and confirmed cases of dengue, chikungunya fever and Zika virus fever. Therefore, if the null hypothesis is rejected, the immunogenicity and safety results of immunobridging will be used to expand the use of Dengue 1,2,3,4 (attenuated) for the age group of 60 - 79 years old.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Dengue
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
This is a randomized, double-blind (60-79 years old) and open-label (40-59 years), three-arm parallel Phase 3b, multicenter study to evaluate the safety and non-inferiority of the humoral immune response of the Butantan Dengue vaccine (Dengue 1,2,3,4 (attenuated)) in participants aged 60 - 79 years (elderly) compared to participants aged 40 to 59 years (adults), with or without previous dengue and healthy based on clinical examination. The 997 participants will be randomized with a 9:3:1 allocation, so that the largest group (60 - 79 years) will be allocated to receive Dengue 1,2,3,4 (attenuated) in a blinded regimen (n=690), the next group (40-59 years) will be allocated to receive Dengue 1,2,3,4 (attenuated) in an open regimen (n=230) and the last (60-79 years) will be allocated to receive placebo (n=77), respectively.
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Quadruple (Care Provider, Investigator, Outcomes Assessor); double (elderly participants).
The clinical care team, the professional responsible for the vaccination and the elderly participant will not know which investigational product will be administered.
Only the pharmacists responsible for storing, preparing and dispensing the investigational product of the study will have access to the unblinded information (randomization code). The allocation of the study product will be revealed only after the completion of the follow-up of the participants and the closing of the database to ensure the evaluation of the long-term safety of the product.
The clinical care team, the professional responsible for the vaccination and the elderly participant will not know which investigational product will be administered.
Only the pharmacists responsible for storing, preparing and dispensing the investigational product of the study will have access to the unblinded information (randomization code). The allocation of the study product will be revealed only after the completion of the follow-up of the participants and the closing of the database to ensure the evaluation of the long-term safety of the product.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Dengue 1,2,3,4 (attenuated) vaccine in a single dose older adult
Participants (60-79y) receiving Butantan DV (N=690)
Group Type
EXPERIMENTAL
Dengue 1,2,3,4 (attenuated) vaccine
Intervention Type
BIOLOGICAL
Each 0.5 mL dose of the lyophilized formulation of Dengue 1,2,3,4 (attenuated) presents an approximate concentration of 103.0 PFU of each vaccine virus rDEN1Δ30-1545, rDEN2/4Δ30(ME)-1495,7163, rDEN3Δ30/31-7164, rDEN4Δ30-7132,7163,8308.
Dengue 1,2,3,4 (attenuated) vaccine in a single dose adult
Participants (40-59y) receiving Butantan DV (N=230)
Group Type
EXPERIMENTAL
Dengue 1,2,3,4 (attenuated) vaccine
Intervention Type
BIOLOGICAL
Each 0.5 mL dose of the lyophilized formulation of Dengue 1,2,3,4 (attenuated) presents an approximate concentration of 103.0 PFU of each vaccine virus rDEN1Δ30-1545, rDEN2/4Δ30(ME)-1495,7163, rDEN3Δ30/31-7164, rDEN4Δ30-7132,7163,8308.
Placebo
Participants (60-79y) receiving Placebo (N=77)
Group Type
PLACEBO_COMPARATOR
Dengue 1,2,3,4 (attenuated) vaccine
Intervention Type
BIOLOGICAL
Each 0.5 mL dose of the lyophilized formulation of Dengue 1,2,3,4 (attenuated) presents an approximate concentration of 103.0 PFU of each vaccine virus rDEN1Δ30-1545, rDEN2/4Δ30(ME)-1495,7163, rDEN3Δ30/31-7164, rDEN4Δ30-7132,7163,8308.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dengue 1,2,3,4 (attenuated) vaccine
Each 0.5 mL dose of the lyophilized formulation of Dengue 1,2,3,4 (attenuated) presents an approximate concentration of 103.0 PFU of each vaccine virus rDEN1Δ30-1545, rDEN2/4Δ30(ME)-1495,7163, rDEN3Δ30/31-7164, rDEN4Δ30-7132,7163,8308.
Intervention Type
BIOLOGICAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* a. Healthy participants aged between 40 and 79 years at the time of study entry, with or without a history of exposure to dengue fever;
b. Agree to periodic contact by telephone, electronic means, and home visits and to the research center;
c. Participants with reproductive potential must be using some effective contraceptive method at screening and continue using it for up to 90 days after the intervention; except in cases where the volunteer declares that she is not at risk of becoming pregnant, either by not engaging in sexual activities or by engaging in them in a non-reproductive manner, up to 90 days after vaccination;
d. Demonstrate intent to participate in the study, documented by the participant's signature of the informed consent form, as well as the study procedures, including completing the Participant Diaries, blood collection, and being available for scheduled study visits and contacts.
b. Agree to periodic contact by telephone, electronic means, and home visits and to the research center;
c. Participants with reproductive potential must be using some effective contraceptive method at screening and continue using it for up to 90 days after the intervention; except in cases where the volunteer declares that she is not at risk of becoming pregnant, either by not engaging in sexual activities or by engaging in them in a non-reproductive manner, up to 90 days after vaccination;
d. Demonstrate intent to participate in the study, documented by the participant's signature of the informed consent form, as well as the study procedures, including completing the Participant Diaries, blood collection, and being available for scheduled study visits and contacts.
Exclusion Criteria
* a. For female participants with reproductive potential: pregnancy (confirmed by positive β-hCG test), breastfeeding or manifest intention to have sexual practices with reproductive potential without using a contraceptive method in the 90 days following vaccination;
b. Planned donation of blood, semen or eggs in the 90 days following vaccination;
c. Evidence of active uncontrolled neurological, cardiac, pulmonary, hepatic or renal disease according to anamnesis or physical examination, at the discretion of the investigator;
d. Diseases that compromise the immune system, including: decompensated diabetes mellitus, active neoplasms or history of neoplasms in the last five years (except basal cell carcinoma), congenital or acquired immunodeficiencies (including HIV/AIDS), solid organ transplants (heart, liver, pancreas, lung, kidney) or uncontrolled autoimmune diseases according to anamnesis or physical examination, as well as a history of liver failure, heart failure or terminal chronic kidney disease or dialysis;
e. Behavioral, cognitive, or psychiatric illness that, in the opinion of the principal investigator or his/her medical representative, affects the potential participant's ability to understand and comply with the requirements of the study protocol;
f. Any abuse of alcohol or drugs in the last 12 months prior to enrollment in the study that has caused medical, professional, or family problems, as indicated by the clinical history;
g. History of severe allergic reaction or anaphylaxis to the vaccine or components of the study vaccine;
h. History of asplenia;
i. Participation in another clinical trial with administration of an investigational product during the six months prior to enrollment in the study or scheduled participation in another clinical trial in the 12 months following enrollment;
j. Previous participation in a dengue vaccine evaluation study or previous exposure to dengue vaccine;
k. Use of immunosuppressive therapies six months prior to enrollment in the study or their scheduled use in the 12 months following enrollment. The following immunosuppressive therapies will be considered: antineoplastic chemotherapy, radiotherapy, immunosuppressants to induce tolerance to transplants, monoclonal antibody therapy for the treatment of rheumatological diseases, among others;
l.Having received an immunosuppressive dose of corticosteroid in the last three months prior to inclusion in the study or administration of an immunosuppressive dose of corticosteroid for the 12 months following inclusion in the study. The dose of corticosteroid considered immunosuppressive is the equivalent of prednisone at a dose of 20 mg/day, for adults, for 14 days (cumulative dose equivalent to at least 280 mg of prednisone). Continuous use of topical or nasal corticosteroid is not considered immunosuppressive;
m. Having received blood products (transfusions or immunoglobulins) in the last three months prior to inclusion in the study, or scheduled administration of blood products or immunoglobulin in the 12 months following inclusion in the study;
n. Fever, suspected or measured, in the 72 hours prior to vaccination or axillary temperature ≥ 37.8°C on the day of vaccination (inclusion may be postponed until the potential participant has been fever-free for 72 hours);
o. Having received a live attenuated virus vaccine in the last 28 days or an inactivated vaccine in the last 14 days prior to inclusion in the study, or having been immunized within 12 months of inclusion in the study;
p. Any other condition that, in the opinion of the principal investigator or his/her medical representative, may jeopardize the safety or rights of a potential participant or that prevents him/her from complying with this protocol.
b. Planned donation of blood, semen or eggs in the 90 days following vaccination;
c. Evidence of active uncontrolled neurological, cardiac, pulmonary, hepatic or renal disease according to anamnesis or physical examination, at the discretion of the investigator;
d. Diseases that compromise the immune system, including: decompensated diabetes mellitus, active neoplasms or history of neoplasms in the last five years (except basal cell carcinoma), congenital or acquired immunodeficiencies (including HIV/AIDS), solid organ transplants (heart, liver, pancreas, lung, kidney) or uncontrolled autoimmune diseases according to anamnesis or physical examination, as well as a history of liver failure, heart failure or terminal chronic kidney disease or dialysis;
e. Behavioral, cognitive, or psychiatric illness that, in the opinion of the principal investigator or his/her medical representative, affects the potential participant's ability to understand and comply with the requirements of the study protocol;
f. Any abuse of alcohol or drugs in the last 12 months prior to enrollment in the study that has caused medical, professional, or family problems, as indicated by the clinical history;
g. History of severe allergic reaction or anaphylaxis to the vaccine or components of the study vaccine;
h. History of asplenia;
i. Participation in another clinical trial with administration of an investigational product during the six months prior to enrollment in the study or scheduled participation in another clinical trial in the 12 months following enrollment;
j. Previous participation in a dengue vaccine evaluation study or previous exposure to dengue vaccine;
k. Use of immunosuppressive therapies six months prior to enrollment in the study or their scheduled use in the 12 months following enrollment. The following immunosuppressive therapies will be considered: antineoplastic chemotherapy, radiotherapy, immunosuppressants to induce tolerance to transplants, monoclonal antibody therapy for the treatment of rheumatological diseases, among others;
l.Having received an immunosuppressive dose of corticosteroid in the last three months prior to inclusion in the study or administration of an immunosuppressive dose of corticosteroid for the 12 months following inclusion in the study. The dose of corticosteroid considered immunosuppressive is the equivalent of prednisone at a dose of 20 mg/day, for adults, for 14 days (cumulative dose equivalent to at least 280 mg of prednisone). Continuous use of topical or nasal corticosteroid is not considered immunosuppressive;
m. Having received blood products (transfusions or immunoglobulins) in the last three months prior to inclusion in the study, or scheduled administration of blood products or immunoglobulin in the 12 months following inclusion in the study;
n. Fever, suspected or measured, in the 72 hours prior to vaccination or axillary temperature ≥ 37.8°C on the day of vaccination (inclusion may be postponed until the potential participant has been fever-free for 72 hours);
o. Having received a live attenuated virus vaccine in the last 28 days or an inactivated vaccine in the last 14 days prior to inclusion in the study, or having been immunized within 12 months of inclusion in the study;
p. Any other condition that, in the opinion of the principal investigator or his/her medical representative, may jeopardize the safety or rights of a potential participant or that prevents him/her from complying with this protocol.
Minimum Eligible Age
40 Years
Maximum Eligible Age
79 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundação Butantan
UNKNOWN
Sponsor Role
collaborator
Butantan Institute
OTHER_GOV
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Fernanda C Boulos, MD, PhD
Role: STUDY_DIRECTOR
Instituto Butantan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CWB 02 - Centro Médico São Francisco
Curitiba, Paraná, Brazil
Site Status
PET 01 - Hospital Escola da Universidade de Pelotas - HEUFPEL
Pelotas, Rio Grande do Sul, Brazil
Site Status
POA 05 - Núcleo de Pesquisa do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil
Site Status
POA 02 - Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Site Status
POA 01 - Centro de Pesquisa: Hospital São Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Brazil
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Gubler DJ. Dengue and dengue hemorrhagic fever. Clin Microbiol Rev. 1998 Jul;11(3):480-96. doi: 10.1128/CMR.11.3.480.
Reference Type
BACKGROUND
Laydon DJ, Dorigatti I, Hinsley WR, Nedjati-Gilani G, Coudeville L, Ferguson NM. Efficacy profile of the CYD-TDV dengue vaccine revealed by Bayesian survival analysis of individual-level phase III data. Elife. 2021 Jul 2;10:e65131. doi: 10.7554/eLife.65131.
Reference Type
BACKGROUND
Patel SS, Rauscher M, Kudela M, Pang H. Clinical Safety Experience of TAK-003 for Dengue Fever: A New Tetravalent Live Attenuated Vaccine Candidate. Clin Infect Dis. 2023 Feb 8;76(3):e1350-e1359. doi: 10.1093/cid/ciac418.
Reference Type
BACKGROUND
Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.
Reference Type
BACKGROUND
Kallas EG, Precioso AR, Palacios R, Thome B, Braga PE, Vanni T, Campos LMA, Ferrari L, Mondini G, da Graca Salomao M, da Silva A, Espinola HM, do Prado Santos J, Santos CLS, Timenetsky MDCST, Miraglia JL, Gallina NMF, Weiskopf D, Sette A, Goulart R, Salles RT, Maestri A, Sallum AME, Farhat SCL, Sakita NK, Ferreira JCOA, Silveira CGT, Costa PR, Raw I, Whitehead SS, Durbin AP, Kalil J. Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomised placebo-controlled phase 2 trial. Lancet Infect Dis. 2020 Jul;20(7):839-850. doi: 10.1016/S1473-3099(20)30023-2. Epub 2020 Mar 24.
Reference Type
BACKGROUND
Kallas EG, Cintra MAT, Moreira JA, Patino EG, Braga PE, Tenorio JCV, Infante V, Palacios R, de Lacerda MVG, Batista Pereira D, da Fonseca AJ, Gurgel RQ, Coelho IC, Fontes CJF, Marques ETA, Romero GAS, Teixeira MM, Siqueira AM, Barral AMP, Boaventura VS, Ramos F, Elias Junior E, Cassio de Moraes J, Covas DT, Kalil J, Precioso AR, Whitehead SS, Esteves-Jaramillo A, Shekar T, Lee JJ, Macey J, Kelner SG, Coller BG, Boulos FC, Nogueira ML. Live, Attenuated, Tetravalent Butantan-Dengue Vaccine in Children and Adults. N Engl J Med. 2024 Feb 1;390(5):397-408. doi: 10.1056/NEJMoa2301790.
Reference Type
BACKGROUND
Chiaravalloti-Neto F, da Silva RA, Zini N, da Silva GCD, da Silva NS, Parra MCP, Dibo MR, Estofolete CF, Favaro EA, Dutra KR, Mota MTO, Guimaraes GF, Terzian ACB, Blangiardo M, Nogueira ML. Seroprevalence for dengue virus in a hyperendemic area and associated socioeconomic and demographic factors using a cross-sectional design and a geostatistical approach, state of Sao Paulo, Brazil. BMC Infect Dis. 2019 May 20;19(1):441. doi: 10.1186/s12879-019-4074-4.
Reference Type
BACKGROUND
Schneider M, Narciso-Abraham M, Hadl S, McMahon R, Toepfer S, Fuchs U, Hochreiter R, Bitzer A, Kosulin K, Larcher-Senn J, Mader R, Dubischar K, Zoihsl O, Jaramillo JC, Eder-Lingelbach S, Buerger V, Wressnigg N. Safety and immunogenicity of a single-shot live-attenuated chikungunya vaccine: a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 24;401(10394):2138-2147. doi: 10.1016/S0140-6736(23)00641-4. Epub 2023 Jun 12.
Reference Type
BACKGROUND
Casey RM, Harris JB, Ahuka-Mundeke S, Dixon MG, Kizito GM, Nsele PM, Umutesi G, Laven J, Kosoy O, Paluku G, Gueye AS, Hyde TB, Ewetola R, Sheria GKM, Muyembe-Tamfum JJ, Staples JE. Immunogenicity of Fractional-Dose Vaccine during a Yellow Fever Outbreak - Final Report. N Engl J Med. 2019 Aug 1;381(5):444-454. doi: 10.1056/NEJMoa1710430. Epub 2018 Feb 14.
Reference Type
BACKGROUND
Hou Y, Chen M, Bian Y, Hu Y, Chuan J, Zhong L, Zhu Y, Tong R. Insights into vaccines for elderly individuals: from the impacts of immunosenescence to delivery strategies. NPJ Vaccines. 2024 Apr 10;9(1):77. doi: 10.1038/s41541-024-00874-4.
Reference Type
BACKGROUND
Weinberg A, Lazar AA, Zerbe GO, Hayward AR, Chan IS, Vessey R, Silber JL, MacGregor RR, Chan K, Gershon AA, Levin MJ. Influence of age and nature of primary infection on varicella-zoster virus-specific cell-mediated immune responses. J Infect Dis. 2010 Apr 1;201(7):1024-30. doi: 10.1086/651199.
Reference Type
BACKGROUND
Levin MJ, Oxman MN, Zhang JH, Johnson GR, Stanley H, Hayward AR, Caulfield MJ, Irwin MR, Smith JG, Clair J, Chan IS, Williams H, Harbecke R, Marchese R, Straus SE, Gershon A, Weinberg A; Veterans Affairs Cooperative Studies Program Shingles Prevention Study Investigators. Varicella-zoster virus-specific immune responses in elderly recipients of a herpes zoster vaccine. J Infect Dis. 2008 Mar 15;197(6):825-35. doi: 10.1086/528696.
Reference Type
BACKGROUND
Collier DA, Ferreira IATM, Kotagiri P, Datir RP, Lim EY, Touizer E, Meng B, Abdullahi A; CITIID-NIHR BioResource COVID-19 Collaboration; Elmer A, Kingston N, Graves B, Le Gresley E, Caputo D, Bergamaschi L, Smith KGC, Bradley JR, Ceron-Gutierrez L, Cortes-Acevedo P, Barcenas-Morales G, Linterman MA, McCoy LE, Davis C, Thomson E, Lyons PA, McKinney E, Doffinger R, Wills M, Gupta RK. Age-related immune response heterogeneity to SARS-CoV-2 vaccine BNT162b2. Nature. 2021 Aug;596(7872):417-422. doi: 10.1038/s41586-021-03739-1. Epub 2021 Jun 30.
Reference Type
BACKGROUND
Hanley JA, Lippman-Hand A. If nothing goes wrong, is everything all right? Interpreting zero numerators. JAMA. 1983 Apr 1;249(13):1743-5. No abstract available.
Reference Type
BACKGROUND
Musso D, Ko AI, Baud D. Zika Virus Infection - After the Pandemic. N Engl J Med. 2019 Oct 10;381(15):1444-1457. doi: 10.1056/NEJMra1808246. No abstract available.
Reference Type
BACKGROUND
Wang WW, Mehrotra DV, Chan IS, Heyse JF. Statistical considerations for noninferiority/equivalence trials in vaccine development. J Biopharm Stat. 2006;16(4):429-41. doi: 10.1080/10543400600719251.
Reference Type
BACKGROUND
Donken R, de Melker HE, Rots NY, Berbers G, Knol MJ. Comparing vaccines: a systematic review of the use of the non-inferiority margin in vaccine trials. Vaccine. 2015 Mar 17;33(12):1426-32. doi: 10.1016/j.vaccine.2015.01.072. Epub 2015 Feb 7.
Reference Type
BACKGROUND
Tricou V, Winkle PJ, Tharenos LM, Rauscher M, Escudero I, Hoffman E, LeFevre I, Borkowski A, Wallace D. Consistency of immunogenicity in three consecutive lots of a tetravalent dengue vaccine candidate (TAK-003): A randomized placebo-controlled trial in US adults. Vaccine. 2023 Nov 13;41(47):6999-7006. doi: 10.1016/j.vaccine.2023.09.049. Epub 2023 Oct 24.
Reference Type
BACKGROUND
Torresi J, Heron LG, Qiao M, Marjason J, Chambonneau L, Bouckenooghe A, Boaz M, van der Vliet D, Wallace D, Hutagalung Y, Nissen MD, Richmond PC. Lot-to-lot consistency of a tetravalent dengue vaccine in healthy adults in Australia: a randomised study. Vaccine. 2015 Sep 22;33(39):5127-34. doi: 10.1016/j.vaccine.2015.08.008. Epub 2015 Aug 13.
Reference Type
BACKGROUND
LeFevre I, Bravo L, Folschweiller N, Medina EL, Moreira ED Jr, Nordio F, Sharma M, Tharenos LM, Tricou V, Watanaveeradej V, Winkle PJ, Biswal S. Bridging the immunogenicity of a tetravalent dengue vaccine (TAK-003) from children and adolescents to adults. NPJ Vaccines. 2023 May 25;8(1):75. doi: 10.1038/s41541-023-00670-6.
Reference Type
BACKGROUND
Miettinen O, Nurminen M. Comparative analysis of two rates. Stat Med. 1985 Apr-Jun;4(2):213-26. doi: 10.1002/sim.4780040211.
Reference Type
BACKGROUND
Nogueira ML, Cintra MAT, Moreira JA, Patino EG, Braga PE, Tenorio JCV, de Oliveira Alves LB, Infante V, Silveira DHR, de Lacerda MVG, Pereira DB, da Fonseca AJ, Gurgel RQ, Coelho IC, Fontes CJF, Marques ETA, Romero GAS, Teixeira MM, Siqueira AM, Boaventura VS, Ramos F, Junior EE, de Moraes JC, Whitehead SS, Esteves-Jaramillo A, Shekar T, Lee JJ, Macey J, Kelner SG, Coller BG, Boulos FC, Kallas EG; Phase 3 Butantan-DV Working Group. Efficacy and safety of Butantan-DV in participants aged 2-59 years through an extended follow-up: results from a double-blind, randomised, placebo-controlled, phase 3, multicentre trial in Brazil. Lancet Infect Dis. 2024 Nov;24(11):1234-1244. doi: 10.1016/S1473-3099(24)00376-1. Epub 2024 Aug 5.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DEN-04-IB
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Immunogenicity and Safety of Three Formulations of Dengue Vaccines in Healthy Adults Aged 18 to 45 Years in the US
NCT00617344
COMPLETED
PHASE2
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN4delta30-4995) in Healthy Adults
NCT00322946
COMPLETED
PHASE1
Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)
NCT05507450
COMPLETED
PHASE2
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3delta30/31-7164) in Healthy Adults
NCT00831012
COMPLETED
PHASE1
A Phase 1 Safety Study of Dengusiil in Healthy Adults
NCT04035278
COMPLETED
PHASE1
Evaluating the Safety and Immune Response to a Dengue Virus Vaccine in Healthy Adults
NCT01931176
COMPLETED
PHASE1
Evaluating the Safety and Effectiveness of a Dengue Virus Vaccine in Healthy Adults
NCT02021968
COMPLETED
PHASE1
Safety and Immunogenicity of a Tetravalent Dengue Vaccine in HIV-Positive Adults
NCT02741128
COMPLETED
PHASE2
Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate (TDV) in Flavivirus-Naïve and Dengue-Immune Adults
NCT03746015
COMPLETED
PHASE2
Evaluating the Safety, Tolerability, and Immunogenicity of a Tetravalent Dengue Vaccine (V180) in Healthy Adults Who Previously Received a Live-Attenuated Tetravalent Vaccine (TV003 or TV005)
NCT02450838
COMPLETED
PHASE1
Evaluation of the Safety and Efficacy of a Single Dose of a Dengue Vaccine (TV005) in Healthy Adults
NCT02317900
COMPLETED
PHASE1
Evaluating the Safety and Immune Response to Two Admixtures of a Tetravalent Dengue Virus Vaccine
NCT01506570
COMPLETED
PHASE1
Safety and Immunogenicity of Formulations of Dengue Vaccines in Healthy Flavivirus-Naïve Adults
NCT00740155
COMPLETED
PHASE2
Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine
NCT01084291
COMPLETED
PHASE1
Study of a Tetravalent Dengue Vaccine in Healthy Adult Subjects Aged 18 to 45 Years in India
NCT01550289
COMPLETED
PHASE2
Evaluating the Safety and Immune Response to Two Doses of a Dengue Virus Vaccine Administered 12 Months Apart
NCT01782300
COMPLETED
PHASE1
A Study of Two Doses of WRAIR Dengue Vaccine Administered Six Months Apart to Healthy Adults and Children
NCT00468858
COMPLETED
PHASE2
Evaluating the Clinical and Immune Response to Two Dengue Virus Vaccines in Healthy Adults
NCT02392325
COMPLETED
PHASE1
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN1delta30) in Healthy Adults
NCT00089908
COMPLETED
PHASE1
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3/4delta30[ME]) in Healthy Adults
NCT00375726
COMPLETED
PHASE1
Study of a Dengue Vaccine (V180) in Healthy Adults (V180-001)
NCT01477580
COMPLETED
PHASE1
Safety of and Immune Response to Two Different Dengue Virus Vaccines in Individuals Previously Immunized Against Dengue Virus
NCT00458120
COMPLETED
PHASE1
A Comparison of the Safety and Immunogenicity of Various Schedules of Dengue Vaccine in Healthy Adult Volunteers
NCT01542632
COMPLETED
PHASE1
A Study on a New Tetravalent Dengue Vaccine (TDV) Formulation in Healthy Adults
NCT07047521
ACTIVE_NOT_RECRUITING
PHASE3
Safety and Immune Response to Two Doses of rDEN2/4delta30 Dengue Vaccine
NCT00920517
COMPLETED
PHASE1