Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine

• Register: ClinicalTrials.gov
• Last refreshed on: 27 February 2024
• Main ID: NCT02406729
• Date of registration: 30/03/2015
• Prospective Registration: Yes
• Primary sponsor: Butantan Institute
• Public title: Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine
• Scientific title: Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Immunogenicity of the Dengue 1, 2, 3, 4 (Attenuated) Vaccine From Instituto Butantan
• Date of first enrolment: February 22, 2016
• Target sample size: 16935
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02406729
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Brazil

Contacts

• Name: Fernanda C Boulos, MD, PhD
• Affiliation: Instituto Butantan

Key inclusion & exclusion 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.

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.



Age minimum: 24 Months
Age maximum: 59 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dengue

Intervention(s)

Other: Placebo

Biological: Dengue 1,2,3,4 (attenuated) vaccine

Primary Outcome(s)

Efficacy (incidence density of symptomatic dengue cases, virologically confirmed) [Time Frame: Five years post vaccination, all cases after 28 days post-vaccination]

Safety (adverse reactions) [Time Frame: In the first 21 days post-vaccination]

Secondary Outcome(s)

Efficacy (incidence density of dengue cases confirmed virologically, regarding previous exposure to dengue viruses. ) [Time Frame: at five years post vaccination, all cases after 28 days post-vaccination]

Efficacy (incidence density of cases of severe dengue and/or with alarm signs, including cases hospitalized or not) [Time Frame: Five years post vaccination, all cases after 28 days post-vaccination]

Immunogenicity (non-inferiority between simplified formulation vs. conventional formulation) [Time Frame: 4 weeks post vaccination]

Safety (frequency of unsolicited adverse reactions) [Time Frame: Five years post vaccination, all cases after the first 21 days post-vaccination]

Immunogenicity (consistency of the immune response to different batches of the vaccine ) [Time Frame: 4 weeks post vaccination]

Efficacy (incidence density of dengue cases confirmed virologically, regarding the viral serotype) [Time Frame: Five years post vaccination, all cases after 28 days post-vaccination]

Safety ( frequency of solicited and unsolicited local and systemic adverse reactions in participants regarding previous exposure to dengue viruses ) [Time Frame: In the first 21 days post-vaccination]

Secondary ID(s)

DEN-03-IB

U1111-1168-8679

Source(s) of Monetary Support

Please refer to primary and secondary sponsors