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Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01373281
First received: June 8, 2011
Last updated: September 18, 2014
Last verified: September 2014

June 8, 2011
September 18, 2014
June 2011
August 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01373281 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia
Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia

The aim of this trial is to assess the efficacy of the CYD dengue vaccine in preventing symptomatic, virologically-confirmed dengue cases.

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 aged 2 to 14 years at the time of inclusion.

Secondary Objectives:

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Dengue
  • Dengue Fever
  • Dengue Hemorrhagic Fever
  • Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus
    0.5 mL, Subcutaneous
    Other Name: CYD Dengue Vaccine
  • Biological: Placebo: NaCl 0.9%
    0.5 mL, Subcutaneous
  • Experimental: Dengue Vaccine Group
    Participants will receive CYD dengue vaccine at 0, 6, and 12 months
    Intervention: Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus
  • Placebo Comparator: Control Group
    Participants will receive a placebo vaccine at 0, 6, and 12 months
    Intervention: Biological: Placebo: NaCl 0.9%
Capeding MR, Tran NH, Hadinegoro SR, Ismail HI, Chotpitayasunondh T, Chua MN, Luong CQ, Rusmil K, Wirawan DN, Nallusamy R, Pitisuttithum P, Thisyakorn U, Yoon IK, van der Vliet D, Langevin E, Laot T, Hutagalung Y, Frago C, Boaz M, Wartel TA, Tornieporth NG, Saville M, Bouckenooghe A; the CYD14 Study Group. Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial. Lancet. 2014 Jul 10. pii: S0140-6736(14)61060-6. doi: 10.1016/S0140-6736(14)61060-6. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10278
November 2017
August 2014   (final data collection date for primary outcome measure)

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.
Both
2 Years to 14 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Indonesia,   Malaysia,   Philippines,   Thailand,   Vietnam
 
NCT01373281
CYD14, UTN: U1111-1116-4957
Yes
Sanofi ( Sanofi Pasteur, a Sanofi Company )
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur SA
Sanofi
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP