Study of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia

Sanofi

Status and phase

Completed

Phase 3

Conditions

Dengue Hemorrhagic Fever

Dengue Fever

Treatments

Biological: Placebo: NaCl 0.9%

Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus

Study type

Interventional

Funder types

Industry

Identifiers

NCT01254422

CYD32

UTN: U1111-1115-6579 (Other Identifier)

Details and patient eligibility

About

The purpose of this study was to evaluate the safety and immunogenicity of Phase III lots of the CYD dengue vaccine in a pediatric population in Malaysia.

Primary Objectives:

To describe the safety (in terms of solicited and unsolicited adverse events) of the CYD dengue vaccine in all participants after each injection.
To describe the antibody response to each dengue virus serotype post-injection 2 and post-injection 3.

Full description

Healthy participants aged 2 to 11 years received 3 vaccinations at pre-determined schedules and were followed-up for at least 6 months after the last vaccination.

Enrollment

250 patients

Sex

All

Ages

2 to 11 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged 2 to 11 years on the day of inclusion
Assent form was signed and dated by the participant (for participants ≥ 7 years) and informed consent form was signed and dated by the parent(s) or another legally accepted representative, and by an independent witness if the two parents or legally accepted representative were illiterate
Participant and parent/legally accepted representative were able to attend all scheduled visits to comply with all trial procedures
Participants in good health, based on medical history and physical examination
For a female participant of childbearing potential, use of an effective method of contraception or abstinence for at least 4 weeks prior to the first vaccination, until at least 4 weeks after the last vaccination

Exclusion criteria

Known pregnancy, or a positive urine pregnancy test (for female participant of child-bearing potential only)
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Planned receipt of any vaccine in the 4 weeks following the trial first vaccination, except for pandemic influenza vaccination
Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Seropositivity for human immunodeficiency virus (HIV) reported by the parent/legally acceptable representative
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion
Participants who plan to move to another country/region within the 18 coming months
Identified as a child (adopted or natural) of the Investigator or of site employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center.