Dengue MedDRA version: 20.0 Level: LLT Classification code 10012309 Term: Dengue System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Dengue 1,2,3,4 (Attenuated) Vaccine
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: NA
Other descriptive name: Live-attenuated Dengue (serotype 4) rDENV
Sponsors
Instituto Butantan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children who have completed 24 months of age, adolescents and adults who have not completed 60 years of age; 2. Agree with periodic contacts, either/or by phone, electronic means, and home visits. 3. Show voluntary intention to participate in the study, documented by the participant's or participant's legal representative's signature of the informed consent form. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. For women: Pregnancy (confirmed by positive beta-hCG test) or breastfeeding; 2. Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as per clinical history and/or physical examination; 3. Compromised immune system diseases including: decompensated diabetes mellitus, cancer (except basal cell carcinoma), congenital or acquired immune deficiencies and not controlled autoimmune, as per clinical history and/or physical examination; 4. Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements; 5. Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history; 6. History of severe allergic reactions or anaphylaxis to the vaccine or to components of the vaccine in study; 7. History of asplenia; 8. Use of any investigational product within 28 days before or after receiving this study vaccination; 9. Has participated in another clinical trial six months prior to inclusion in the study or planning to participate in another clinical trial within 2 years following inclusion; 10. Use of immunosuppressant drugs such as: antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use (except topical or nasal). For this protocol will be considered for exclusion use of corticosteroids 3 months prior to the inclusion in the study and 6 months prior to the inclusion for the other therapies mentioned, and planned use of any immunosuppressant therapy within 2 years following inclusion in the study. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose =20 mg of prednisone per day for adults and the equivalent of prednisone at 2 mg/kg/day for children for over 7 days; 11. Have received blood products in the past three months, including transfusions or immunoglobulin, or scheduled administration of blood products or immunoglobulin for the following 2 years after vaccination; 12. Fever or suspected fever within 72 hours prior to vaccination or axillary temperature greater than 37,8°C on the day of vaccination (inclusion might be postponed until participant has completed 72 hours of no fever); 13. Have received live virus vaccine within 28 days or killed virus vaccine in the last 14 days prior to vaccination, or have a scheduled immunization during the first 28 days after receiving the investigational product; 14. Any other condition that might put in risk the safety/rights of a potential participant or hurdle his/her compliance with this protocol in investigator's opinion or his representative physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the overall efficacy of a single dose of the Dengue 1,2,3,4 (attenuated) vaccine produced by Instituto Butantan containing 103 PFU of each vaccine virus against virologically confirmed symptomatic dengue 28 days after vaccination in subjects ranging from 2 to 59 years of age, regardless of their prior exposure to dengue viruses. 2. To describe the onset of adverse reactions associated with administration of a single dose of Dengue 1,2,3,4 (attenuated) Vaccine produced by Instituto Butantan containing 103 PFU of each vaccine virus up to 21 days post-vaccination in subjects from 2 to 59 years of age, regardless of their prior exposure to dengue viruses.;Secondary Objective: 1. Evaluate efficacy of a single dose of the Dengue 1,2,3,4 (attenuated) Vaccine against symptomatic infection 28 days after vaccination with respect to prior exposure to dengue viruses. 2. Evaluate efficacy of a single dose of the Dengue 1,2,3,4 (attenuated) Vaccine against symptomatic infection 28 days after vaccination with respect to the four dengue serotypes. 3. Evaluate efficacy of a single dose of the Dengue 1,2,3,4 (attenuated) Vaccine 28 days after vaccination with respect to the onset of laboratory-confirmed dengue with warning signs and severe dengue. 4. Describe adverse reactions within the first 21 days post-vaccination. 5. Evaluate the immune response 4 weeks after vaccination with 3 consecutive batches of dengue 1, 2, 3, 4 (attenuated) vaccine in a subject subgroup with no prior exposure to dengue. 6. Evaluate the immune response 4 weeks after vaccination with batches produced with the simplified formulation in subjects with no prior exposure to dengue. ;Primary end point(s): 1. Efficacy (incidence density of symptomatic dengue cases, virologically confirmed) 2. Safety (adverse reactions) ;Timepoint(s) of evaluation of this end point: 1. Five years post vaccination, all cases after 28 days post-vaccination 2. In the first 21 days post-vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Efficacy (incidence density of dengue cases confirmed virologically, regarding previous exposure to dengue viruses. ) 2. Efficacy (incidence density of dengue cases confirmed virologically, regarding the viral serotype) 3. Efficacy (incidence density of cases of severe dengue and/or with alarm signs, including cases hospitalized or not) 4. Safety ( frequency of solicited and unsolicited local and systemic adverse reactions in participants regarding previous exposure to dengue viruses ) 5. Safety (frequency of unsolicited adverse reactions) 6. Immunogenicity (consistency of the immune response to different batches of the vaccine ) 7. Immunogenicity (non-inferiority between simplified formulation vs. conventional formulation) ;Timepoint(s) of evaluation of this end point: 1. at five years post vaccination, all cases after 28 days post-vaccination 2. Five years post vaccination, all cases after 28 days post-vaccination 3. Five years post vaccination, all cases after 28 days post-vaccination 4. Time Frame: In the first 21 days post-vaccination 5. Five years post vaccination, all cases after the first 21 days post-vaccination 6. 4 weeks post vaccination 7. 4 weeks post vaccination | — |
Countries
Brazil
Contacts
Public ContactMaria Alejandra Esteves Jaramillo
Merck Sharp & Dohme LLC
Outcome results
None listed