Study of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01374516
First received: June 14, 2011
Last updated: February 25, 2014
Last verified: February 2014
  Purpose

The aim of the study is to assess the efficacy of sanofi pasteur's CYD dengue vaccine in preventing symptomatic virologically-confirmed dengue cases for dengue-endemic areas of Latin America.

Primary Objective:

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 and adolescents aged 9 to 16 years at the time of inclusion.

Secondary Objectives:

To describe the occurrence of serious adverse events (SAEs), including SAEs of special interest in all subjects throughout the trial period.

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

Condition Intervention Phase
Dengue Fever
Dengue Hemorrhagic Fever
Dengue
Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus
Biological: Placebo: NaCl 0.9% solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in Latin America

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 last vaccination ] [ Designated as safety issue: No ]
    Acute febrile illness is temperature ≥ 38°C on at least 2 consecutive days


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20875
Study Start Date: June 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CYD Dengue Vaccine Group
Participants will receive a dose of CYD dengue vaccine at 0, 6, and 12 months, respectively.
Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus
0.5 mL, Subcutaneous
Other Name: CYD Dengue Vaccine
Placebo Comparator: Control Group
Participants will receive a dose of placebo vaccine at 0, 6, and 12 months, respectively.
Biological: Placebo: NaCl 0.9% solution
0.5 mL, Subcutaneous

Detailed Description:

Participants will be randomized to either receive a total of 3 injections of CYD dengue vaccine or a placebo at 0, 6, and 12 months, respectively.

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 yellow fewer antibody levels.

  Eligibility

Ages Eligible for Study:   9 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 9 to 16 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 may interfere with the subject's 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374516

Locations
Brazil
Fortaleza, CE, Brazil, 60430 270
Vitória, ES, Brazil, 29040 09
Goiania, GO, Brazil, 74675 020
Campo Grande, MS, Brazil, 79074 460
Natal, RN, Brazil, 59025 600
Colombia
Aguazul, Casanare, Colombia
Yopal, Casanare, Colombia
Girardot, Cundinamarca, Colombia
Acacias, Meta, Colombia
Armenia, Quindío, Colombia
Calarcá, Quindío, Colombia
La Tebaida, Quindío, Colombia
Montenegro, Quindío, Colombia
Bucaramanga, Santander, Colombia
Honduras
Tegucigalpa, Municipalidad del Distrito Central, Honduras
Mexico
Temixco, Morelos, Mexico
Municipio de Cd. Mante, Tamaulipas, Mexico
Veracruz Puerto, Veracruz, Mexico
Tizimin, Yucatán, Mexico
Valladolid, Yucatán, Mexico
Puerto Rico
Guayama, Puerto Rico, 00784
San Juan, Puerto Rico, 00918
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01374516     History of Changes
Other Study ID Numbers: CYD15, UTN: U1111-1116-4986
Study First Received: June 14, 2011
Last Updated: February 25, 2014
Health Authority: United States: Food and Drug Administration
Brazil: Ministry of Health
Mexico: Ministry of Health
Puerto Rico: General Directorate of Pharmaceuticals, Devices and Drugs

Keywords provided by Sanofi:
Dengue Virus
Dengue fever
Dengue Hemorrhagic Fever
CYD dengue vaccine
Flavivirus
Dengue Disease

Additional relevant MeSH terms:
Dengue
Fever
Severe Dengue
Hemorrhagic Fevers, Viral
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014