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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01254422
First received: December 3, 2010
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

The purpose of this study is 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 subjects after each dose.
  • To describe the antibody response to each dengue virus serotype post-Dose 2 and post-Dose 3

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity of a Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 11 Years in Malaysia

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Information concerning the safety of CYD Dengue vaccine following each dose of vaccine [ Time Frame: Up to 6 months post-dose 3 ] [ Designated as safety issue: No ]
    Safety parameters: solicited injection site pain, erythema, and swelling; solicited systemic reactions - fever (temperature), headache, malaise, myalgia, and asthenia; and unsolicited adverse events.

  • Information on the antibody levels against each of the four parental dengue virus strains of CYD dengue vaccine constructs post Dose 2 and post Dose 3 [ Time Frame: 28 days post dose 2 and 3, respectively. ] [ Designated as safety issue: No ]

Enrollment: 250
Study Start Date: December 2010
Study Completion Date: January 2013
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dengue Vaccine Group
Participants will receive 3 doses of CYD dengue vaccine
Biological: Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus
0.5 mL (at 0, 6, and 12 months), Subcutaneous
Other Name: CYD Dengue vaccine
Placebo Comparator: Control Group
Participants will receive 3 doses of saline
Biological: Placebo: NaCl 0.9%
0.5 mL (at 0, 6, and 12 months), Subcutaneous
Other Name: Saline

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   2 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 2 to 11 years on the day of inclusion
  • Assent form has been signed and dated by the subject (for subjects ≥ 7 years) and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative, and by an independent witness if the two parents or legally acceptable representative are illiterate
  • Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
  • Subject in good health, based on medical history and physical examination
  • For a female subject 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 subject 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, is at a stage where it might interfere with trial conduct or completion
  • Subjects 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.
  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: NCT01254422

Locations
Malaysia
Ipoh, Perak, Malaysia, 30990
Kuala Lumpur, Malaysia, 59100
Kuching, Sarawak, Malaysia, 93586
Negeri Sembilan, Malaysia, 70300
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur Singapore
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01254422     History of Changes
Other Study ID Numbers: CYD32, UTN: U1111-1115-6579
Study First Received: December 3, 2010
Last Updated: February 5, 2013
Health Authority: Malaysia: Ministry of Health

Keywords provided by Sanofi:
Dengue fever
Dengue hemorrhagic fever
CYD dengue vaccine

Additional relevant MeSH terms:
Dengue
Dengue Hemorrhagic Fever
Fever
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 July 20, 2014