Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine
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|ClinicalTrials.gov Identifier: NCT02406729|
Recruitment Status : Active, not recruiting
First Posted : April 2, 2015
Last Update Posted : January 31, 2020
This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that will evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine produced by Butantan Institute.
The study will be carried out in multiple sites in Brazil. The study will be community-based in select urban areas where there's dengue transmission.
Study's intervention will be a single dose of the tetravalent dengue vaccine or placebo in a ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days post-vaccination in the entire population of 16944 participants.
For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21 days after vaccination is analysed for 450 participants in 7-to17-ys age group, the following group, of 2 to 6 ys, will start.
The study's hypothesis is that the vaccine under investigation and produced by Butantan Institute is safe and provides protection against dengue symptomatic disease of 80% or more with a lower bound of the 95% confidence interval of 25%. This way, the expected number of dengue cases virologically confirmed is 24 or more which will provide a response in terms of vaccine efficacy.
All participants will be followed up for five years to verify dengue incidence, regardless severity.
|Condition or disease||Intervention/treatment||Phase|
|Dengue||Biological: Dengue 1,2,3,4 (attenuated) vaccine Other: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16944 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase III Trial to Evaluate Efficacy and Safety of a Dengue 1,2,3,4 (Attenuated) Vaccine|
|Actual Study Start Date :||February 2016|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2024|
Experimental: Dengue 1,2,3,4 (attenuated) vaccine
Dengue 1,2,3,4 (attenuated) vaccine Single dose, SC
Biological: Dengue 1,2,3,4 (attenuated) vaccine
Dose 1000 PFU per virus (1,2,3,4) Route:subcutaneous
Placebo Comparator: Placebo
Placebo Single dose, SC
- Efficacy (incidence density of symptomatic dengue cases, virologically confirmed) [ Time Frame: at 52 weeks post vaccination, all cases after 28 days post-vaccination ]• The primary efficacy outcome is incidence density of symptomatic dengue cases, virologically confirmed, after 28 days post-vaccination. Virological confirmation might be done by viral isolation, RT-PCR and/or detection of NS1.
- Safety (adverse reactions) [ Time Frame: in the first 21 days post-vaccination ]• The primary safety outcome is the frequency of local and systemic adverse reactions, solicited and non-solicited in the three age groups, within the first 21 days post-vaccination. Adverse reactions are defined as adverse events that have a reasonable causal relationship with vaccination.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406729
|Fundação de Medicina Tropical Doutor Heitor Vieira Dourado|
|Manaus, Amazonas, Brazil, 69040-000|
|Instituto Gonçalo Muniz - Fiocruz Bahia|
|Simões Filho, BA, Brazil, 43700-000|
|Universidade Federal do Ceará|
|Fortaleza, CE, Brazil, 60430-160|
|Universidade de Brasília|
|Brasilia, DF, Brazil, 71691-082|
|Universidade Federal de Minas Gerais|
|Belo Horizonte, MG, Brazil, 30750-140|
|Hospital Universitário Júlio Müller da Universidade Federal de Mato Grosso|
|Cuiabá, Mount, Brazil, 78048-610|
|Universidade Federal de Mato Grosso do Sul|
|Campo Grande, MS, Brazil, 79070-900|
|Centro de Pesquisas Aggeu Magalhães - Fiocruz Pernambuco|
|Recife, Pernambuco, Brazil, 50740-465|
|Universidade Federal de Roraima - UFRR|
|Boa Vista, Roraima, Brazil, 69304-000|
|Centro de Pesquisas em Medicina Tropical de Rondônia (CEPEM)|
|Porto Velho, RO, Brazil, 78918-791|
|Hospital São Lucas da Pontificia Universidade Catolica do Rio Grande do Sul|
|Porto Alegre, RS, Brazil, 90619-900|
|Universidade Federal de Sergipe|
|Laranjeiras, SE, Brazil, 49170-000|
|Santa Casa de Misericórdia de São Paulo - CSEBF|
|São Paulo, SP, Brazil, 01133-020|
|Faculdade de Medicina de São José do Rio Preto - FAMERP|
|São José Do Rio Preto, São Paulo, Brazil, 15090-000|
|Instituto de Infectologia Evandro Chagas - Fiocruz|
|Rio De Janeiro, Brazil, 21710-232|
|São Paulo, Brazil, 05403-000|
|Study Director:||Ricardo Palacios, MD, PhD||Butantan Institute|
|Principal Investigator:||Esper G Kallas, MD, PhD||School of Medicine, University of São Paulo|