Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-26

Study Completion Date

2010-08-16

Brief Summary

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The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine, against dengue disease.

Primary Objectives:

* To describe the humoral immune response to dengue before and after each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years) previously vaccinated with yellow fever (YF) vaccine.
* To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years).
* To describe viremia after the first and second vaccinations with dengue vaccine in a subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30 participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5 years).

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Detailed Description

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Participants were randomized to receive either three injections of CYD dengue vaccine or two injections of placebo, and one injection of a pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively.

Conditions

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Dengue Virus Dengue Fever Dengue Hemorrhagic Fever Dengue Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The observer-blind design was implemented. The person who performed vaccinations knew which product was administered while neither the participant nor the Investigator in charge of safety evaluation knew which product was injected. To maintain the blind and minimize any potential bias, the control group used the same route and schedule as the study vaccine.

Study Groups

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CYD Dengue vaccine group

Participants received three injections of the CYD Dengue vaccine at 0, 6, and 12 months. Participants were followed for 6 months after the last vaccination (up to 18 months).

Group Type EXPERIMENTAL

CYD Dengue Vaccine Serotypes 1, 2, 3, and 4

Intervention Type BIOLOGICAL

0.5 mL, Subcutaneous (SC)

Control group

Participants received two injections of placebo, and one injection of pneumococcal polysaccharide vaccine (Pneumo23®) at 0, 6, and 12 months, respectively. Participants were followed for 6 months after the last vaccination (up to 18 months).

Group Type PLACEBO_COMPARATOR

Pneumococcal polysaccharide vaccine

Intervention Type BIOLOGICAL

0.5 mL, SC

Interventions

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CYD Dengue Vaccine Serotypes 1, 2, 3, and 4

0.5 mL, Subcutaneous (SC)

Intervention Type BIOLOGICAL

Pneumococcal polysaccharide vaccine

0.5 mL, SC

Intervention Type BIOLOGICAL

Other Intervention Names

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ChimeriVax™ Pneumo23®

Eligibility Criteria

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Inclusion Criteria

* Aged 2 to 11 years on the day of inclusion.
* Participant in good health, based on medical history, physical examination and laboratory parameters.
* Provision of Assent Form signed by the participants (for participants \>=8 years old) and Informed Consent Form signed by the parents or another legally acceptable representative (and by an independent witness for illiterate parent\[s\]).
* Participant and parents/legally acceptable representative able to attend all scheduled visits and to comply with all trial procedures.
* For a female participant of child-bearing potential (girls post-menarche), 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.
* Documented receipt of yellow fever vaccine since at least one month before the first vaccination.

Exclusion Criteria

* Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia.
* For a female participant of child-bearing potential (girls post-menarche), known pregnancy.
* For a female participant of child-bearing potential (girls post-menarche), known pregnancy or positive pregnancy test in blood sample taken at Screening.
* 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 trial.
* 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 vaccines components or history of a life-threatening reaction to the trial vaccines or to a vaccine containing any of the same substances.
* Systemic hypersensitivity to YF vaccine or history of a life-threatening reaction to YF vaccine.
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator.
* Current or past alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures.
* Receipt of any blood or blood-derived products in the past 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.
* Human Immunodeficiency Virus, hepatitis B antigen, or hepatitis C seropositivity in blood sample taken at Screening.
* Clinically significant laboratory abnormalities (as determined by the Investigator) in blood sample taken at Screening.
* Known previous vaccination with pneumococcal polysaccharide vaccine.

Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes