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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-07

Study Completion Date

2014-10-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dengue Fever Dengue Hemorrhagic Fever Dengue Virus Dengue Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

An observer-design for the first vaccination and a single-blind design for the second and third vaccination were chosen to minimize the bias of the vaccine evaluation. The Investigator in charge of safety evaluation, the Sponsor, and the participants/parents did not know which vaccine was administrated at the first visit. For the second and third vaccinations, the participants/parents did not know which vaccine was administered.

Study Groups

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CYD Dengue Vaccine Group

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

Group Type EXPERIMENTAL

CYD Dengue vaccine

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous on Day 0, Months 6 and 12

Placebo Group

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.

Group Type SHAM_COMPARATOR

NaCl + influenza virus or hepatitis A vaccine

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)

Interventions

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CYD Dengue vaccine

0.5 mL, Subcutaneous on Day 0, Months 6 and 12

Intervention Type BIOLOGICAL

NaCl + influenza virus or hepatitis A vaccine

0.5 mL, Subcutaneous (Intramuscular - Hepatitis A)

Intervention Type BIOLOGICAL

Other Intervention Names

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Sanofi Pasteur's CYD Dengue Vaccine NaCl 0.9% Vaxigrip® Havrix® pediatric formulation

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes