Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore

Sanofi

Status and phase: Completed; Phase 2

Conditions: Dengue Hemorrhagic Fever; Dengue Fever; Dengue Virus; Dengue Diseases

Treatments: Biological: NaCl + influenza virus or hepatitis A vaccine; Biological: CYD Dengue vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00880893

2014-001713-26 (EudraCT Number)

CYD28

Details and patient eligibility

About

Primary Objectives:

• To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity.
• To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period.
• To evaluate the humoral immune response to each CYD Dengue serotype after each vaccination in a subset of participants.

Secondary Objectives:

• To evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.

Full description

This was a multicenter trial involving three vaccinations one each at 0, 6 and 12 months over a period of 1 year, and a 4-year follow-up following the last vaccination.

Enrollment: 1,198 patients

Sex: All

Ages: 2 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• Aged from 2 to 45 years on the day of inclusion.
• Participant in good health, based on medical history and physical examination.
• Provision of informed consent form (and assent form for participants aged 6 to 12 years) signed by the participant and by the parent(s) or another legally acceptable representative for participants aged less than 21 years.
• Participants and parent(s)/legally acceptable representative able to attend all scheduled visits and comply with all trial procedures.
• For a woman of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks before the first vaccination until 4 weeks after the last vaccination.

Exclusion Criteria :

• Febrile illness (temperature >= 37.5°C) or moderate or severe acute illness/infection on the day of the first vaccination, according to Investigator judgment.
• For a woman of child-bearing potential, known pregnancy or positive urine pregnancy test on the day of inclusion.
• Breast-feeding woman.
• Known systemic hypersensitivity to any of the components of the trial vaccines (especially egg proteins or neomycin) or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
• Personal or family history of thymic pathology or myasthenia.
• Previous hepatitis A vaccination (for children only).
• Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the past 6 months, or long-term systemic corticosteroid therapy.
• Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
• Receipt of blood or blood-derived products in the past 3 months that might interfere with the assessment of immune response.
• Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination.
• Planned participation in another clinical trial during the 18 coming months.
• 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.
• Participant deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
• Current or past alcohol abuse or drug addiction that may interfere with the participants ability to comply with trial procedures.
• Participant who plans to move to another country within the 18 coming months.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,198 participants in 2 patient groups

CYD Dengue Vaccine Group

Experimental group

Description:

Participant's received the CYD Dengue Vaccine at 0, 6, and 12 months as first, second, and third vaccinations, respectively.

Treatment:

Biological: CYD Dengue vaccine

Placebo Group

Sham Comparator group

Description:

All participants received a placebo at first vaccination (Month 0). Participants <12 years received hepatitis A at second (Month 6) and third (Month 12) vaccinations. Participants >= 12 years received influenza vaccine of Northern and Southern hemisphere formulations at second (Month 6) and third (Month 12) vaccinations.

Treatment:

Biological: NaCl + influenza virus or hepatitis A vaccine