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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01254422
Recruitment Status : Completed
First Posted : December 6, 2010
Last Update Posted : September 19, 2014
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment 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

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : December 2010
Primary Completion Date : September 2012
Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue Fever
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Information concerning the safety of CYD Dengue vaccine following each dose of vaccine [ Time Frame: Up to 6 months post-dose 3 ]
    Safety parameters: solicited injection site pain, erythema, and swelling; solicited systemic reactions - fever (temperature), headache, malaise, myalgia, and asthenia; and unsolicited adverse events.

  2. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01254422

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

Additional Information:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01254422     History of Changes
Other Study ID Numbers: CYD32
UTN: U1111-1115-6579 ( Other Identifier: WHO )
First Posted: December 6, 2010    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014

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

Additional relevant MeSH terms:
Hemorrhagic Fevers, Viral
Severe Dengue
Body Temperature Changes
Signs and Symptoms
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Immunologic Factors
Physiological Effects of Drugs