Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia
This trial is active, not recruiting.
|Conditions||dengue, dengue fever, dengue hemorrhagic fever|
|Treatments||live, attenuated, dengue serotype 1, 2, 3, 4 virus, placebo: nacl 0.9%|
|Sponsor||Sanofi Pasteur, a Sanofi Company|
|Start date||June 2011|
|End date||August 2014|
|Trial size||10278 participants|
|Trial identifier||NCT01373281, CYD14, UTN: U1111-1116-4957|
The aim of this trial is to assess the efficacy of the CYD dengue vaccine in preventing symptomatic, virologically-confirmed dengue cases.
To assess the efficacy of CYD dengue vaccine after 3 vaccinations at 0, 6, and 12 months in preventing symptomatic virologically-confirmed dengue cases, regardless of the severity, due to any of the four serotypes in children aged 2 to 14 years at the time of inclusion.
To describe the efficacy of CYD dengue vaccine after each dose in:
- Preventing symptomatic virologically-confirmed dengue cases due to any of the four serotypes
- Preventing symptomatic dengue cases, either virologically-confirmed or probable based on serological criteria, due to any of the four serotypes
To describe the occurrence of serious adverse events (SAEs), including serious adverse events of special interest in all subjects throughout the trial period.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Denpasar, Indonesia 80114||not available||no longer recruiting|
|Bandung, Indonesia 40161||not available||no longer recruiting|
|Jakarta, Indonesia 10430||not available||no longer recruiting|
|Kuala Lumpur, Malaysia 50586||not available||no longer recruiting|
|Penang, Malaysia 10450||not available||no longer recruiting|
|Cebu City, Philippines 6000||not available||no longer recruiting|
|San Pablo City, Philippines||not available||no longer recruiting|
|Muang District, Thailand 6200||not available||no longer recruiting|
|Ban Pong Districts, Thailand 70110||not available||no longer recruiting|
|Photharam Districts, Thailand 70120||not available||no longer recruiting|
|Long Xuyen City, Vietnam||not available||no longer recruiting|
|My Tho City, Vietnam||not available||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Information on the symptomatic virologically confirmed dengue cases occurring > 28 days after Dose 3 (during the active phase) in terms of (i) Acute febrile illness, and (ii) Virologically confirmed
time frame: 28 Days post-vaccination 3
Information on the occurrence of serious adverse events (SAEs), including SAEs of special interest in all subjects throughout the trial period
time frame: Day 0 up to 12 months post vaccination
Information on the efficacy of CYD dengue vaccine in preventing symptomatic dengue cases either virologically confirmed or probable based on serological criteria, due to any of the four serotypes after each dose.
time frame: 28 Days after each vaccination
Male or female participants from 2 years up to 14 years old.
Inclusion Criteria: - Aged 2 to 14 years on the day of inclusion and resident of the site zone - Subject in good health, based on medical history and physical examination - Assent form or informed consent form has been signed and dated by the subject (based on local regulations), and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (and by an independent witness if required by local regulations) - Subject able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: - Subject is pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination). - 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 present trial period - Self-reported 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 corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) - Self-reported seropositivity for Human Immunodeficiency Virus (HIV) infection - Self-reported systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances - Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion - Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response - Planned receipt of any vaccine in the 4 weeks following any trial vaccination - Deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized involuntarily - Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures - Identified as a site employee 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, as well as a family member (i.e., immediate, husband, wife and their children, adopted or natural) of the site employees or the Investigator.
|Official title||Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia|
|Description||Participants will be randomized to either receive 3 injections of CYD dengue vaccine or a placebo at 0, 6, and 12 months. A subset of participants from each country will also be evaluated for reactogenicity and immunogenicity to enable the generation of country-specific data on reactogenicity, immunogenicity, and baseline dengue and JE antibody levels.|
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