Immunogenicity and Safety of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Children and Adolescents in Latin America

Sanofi Pasteur, a Sanofi Company600 enrolled

Overview

Primary objectives: * To describe the immune response to each dengue serotype before and after each vaccination with sanofi pasteur's CYD dengue vaccine. * To evaluate the safety of each vaccination with sanofi pasteur's CYD dengue vaccine.

The antibody levels against each serotype will be measured before and after each vaccination. The subjects will be followed for 28 days after each vaccination for solicited and unsolicited safety parameters. Serious adverse events (SAEs) will be collected throughout the study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

600

Conditions

Dengue Dengue Hemorrhagic Fever Dengue Virus Dengue Fever

Interventions

CYD Dengue VaccineBIOLOGICAL

0.5 mL, Subcutaneous at Day 0, 6 and 12 months

Tetanus Toxoid Reduced Diphtheria Toxoid Acellular PertussisBIOLOGICAL

NaCl: 0.5 mL, Intramuscular at Day 0 and 6 months; Adacel®: 0.5 mL, Intramuscular at 12 months

Eligibility

Sex: ALLMin age: 9 YearsMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria : * Aged 9 to 16 years on the day of inclusion * Subject in good health, based on medical history and physical examination * Provision of assent form/informed consent form signed by the subject and by the parent(s) or another legally acceptable representative * Subject and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures * For a female subject of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination until at least 4 weeks after the last vaccination. Exclusion Criteria : * Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia * For a female subject of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1 * Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination * Breast-feeding woman * Planned participation in another clinical trial during the present trial period * Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy * Known systemic hypersensitivity to any of the components of any of the trial vaccines or history of a life-threatening reaction to any of the trial vaccines or to a vaccine containing any of the same substances * Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator * Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures * Receipt of blood or blood-derived products in the preceding 3 months that might interfere with the assessment of immune response * Receipt of any vaccine in the 4 weeks preceding the first trial vaccination * Planned receipt of any vaccine in the 4 weeks following the first trial vaccination * Subject deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent * Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment * Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination * Severe diseases with or without fever, convulsions or neurological abnormalities without treatment or in progression.

Locations (4)

Unnamed facility

Bucaramanga, Colombia

Unnamed facility

Tegucigalpa, Honduras

Unnamed facility

Cuernavaca, Mexico

Unnamed facility

San Juan, Puerto Rico

Outcomes

Primary Outcomes

Percentage of Participants With Antibody Titers of ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination

Percentage of Flavi Virus-Immune Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) immune participants at baseline are defined as those participants with ≥ 10 1/dil for at least one serotype with the parental dengue virus strain or for Yellow Fever titer.

Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination

Percentage of Flavi Virus-Naive Participants at Baseline With Antibody Titers ≥10 1/Dil Against Each Parental Dengue Virus Serotype Strain Before and Following Each Injection With Sanofi Pasteur's CYD Dengue Vaccine

Neutralizing antibody levels against each of the 4 parental dengue virus strains of Sanofi Pasteur's CYD dengue vaccine constructs were measured using the dengue plaque reduction neutralization test (PRNT). Flavi virus (FV) naïve participants are defined as those participants with \< 10 1/dil for all serotypes with parental dengue virus strains and for Yellow Fever titer.

Time frame: Day 0 (pre-each vaccination) and Day 28 post-each vaccination

Percentage of Participants With Antibody Titers of ≥10 1/Dil Against At Least 1, 2, 3, or 4 Serotypes With Parental Dengue Virus Strain Before and Following Each Injection With Either Sanofi Pasteur's CYD Dengue Vaccine or A Placebo Vaccine

Data from ClinicalTrials.gov

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