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

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ClinicalTrials.gov Identifier: NCT01373281
Recruitment Status : Completed
First Posted : June 14, 2011
Results First Posted : November 16, 2015
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Brief Summary:

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 (VCD) 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 in preventing symptomatic VCD cases after the third dose to the end of the Active Phase, after at least 1 dose, and after 2 doses.
  • To describe the occurrence of serious adverse events (SAEs), including SAEs of special interest in all subjects throughout the trial period.

Condition or disease Intervention/treatment Phase
Dengue Dengue Fever Dengue Hemorrhagic Fever Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus Biological: Placebo: Sodium chloride (NaCl) 0.9% Phase 3

Detailed Description:

Participants were 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 were also evaluated for reactogenicity and immunogenicity to enable the generation of country-specific data on reactogenicity, immunogenicity.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10275 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy and Safety of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia
Actual Study Start Date : June 1, 2011
Actual Primary Completion Date : August 1, 2014
Actual Study Completion Date : November 21, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arm Intervention/treatment
Experimental: Dengue Vaccine Group
Participants are to receive CYD dengue vaccine at 0, 6, and 12 months
Biological: Live, attenuated, dengue serotype 1, 2, 3, 4 virus
0.5 mL, Subcutaneous
Other Name: CYD Dengue Vaccine

Placebo Comparator: Control Group
Participants are to receive a placebo vaccine at 0, 6, and 12 months
Biological: Placebo: Sodium chloride (NaCl) 0.9%
0.5 mL, Subcutaneous




Primary Outcome Measures :
  1. Number of Symptomatic Virologically Confirmed Dengue (VCD) Cases Due to Any Serotype During the Active Phase Post-dose 3 Following Injection With Either CYD Dengue Vaccine or a Placebo [ Time Frame: 28 days and up to 13 months post-dose 3 ]
    Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature ≥38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue non-structural protein (NS) 1 antigen enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.


Secondary Outcome Measures :
  1. Geometric Mean Titers of Antibodies Against Each Serotype With the Parental Dengue Virus Strain Before and Following Injection With Either CYD Dengue Tetravalent Vaccine or a Placebo [ Time Frame: Pre-injection 1 and 28 days post Injections 2 and 3 ]
    Geometric mean titers against each serotypes of the dengue virus strains were assessed using the plaque reduction neutralization test (PRNT) in a pre-defined subset of 2,000 participants.

  2. Percentage of Participants With Antibody Titers ≥10 1/Dil Against Each Dengue Virus Serotype Strain Before and Following Injection With CYD Dengue Vaccine or Placebo [ Time Frame: Pre-injection 1 and 28 days post-injections 2 and 3 ]
    Percentage of participants with antibody titers≥10 1/dil against each serotypes of the dengue virus strains were assessed using PRNT in a pre-defined subset of 2,000 subjects.

  3. Number of Symptomatic VCD Cases Due to Any Serotype Post-dose 1 Following Injection With Either CYD Dengue Vaccine or a Placebo. [ Time Frame: 28 days post-injection 1 and up to 13 months post-injection 3 ]
    Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature ≥38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.

  4. Number of Symptomatic VCD Cases Due to Any Serotype Post-dose 2 Following Injection With Either CYD Dengue Vaccine or a Placebo. [ Time Frame: 28 days post-injection 2 and up to 13 months post-injection 3 ]
    Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature ≥38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.

  5. Number of Symptomatic VCD Cases Due to Any Serotype During the Active Phase Following Injection With Either CYD Dengue Vaccine or a Placebo. [ Time Frame: Day 0 up to 13 months post-injection 3 ]
    Symptomatic VCD cases were defined as occurrence of acute febrile illness (temperature ≥38°C on at least 2 consecutive days) and confirmation of dengue virus infection by dengue reverse transcriptase polymerase chain reaction and/or dengue NS1 enzyme-linked immunosorbent assay. Vaccine efficacy was defined as 1 minus the ratio of density incidence due to any serotype after at least 1 dose in the CYD Dengue Vaccine Group over the density incidence of the Placebo Vaccine Group.

  6. Number of Symptomatic VCD Cases Meeting World Health Organization (WHO) Criteria During the Active Phase Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo. [ Time Frame: Day 0 up to 13 months post-injection 3 ]

    Dengue hemorrhagic fever cases defined as number of subjects with at least one symptomatic VCD episode meeting the pre-specified WHO criteria from Day 0 to the end of active phase.

    (a) Fever: acute onset, high (≥ 38°C) and continuous, lasting 2 to 7 days and (b) any of the pre-listed hemorrhagic manifestations: Dengue hemorrhagic fever was graded as follows: Grade I: Fever accompanied by non-specific constitutional symptoms; the only hemorrhagic manifestation is a positive tourniquet test; Grade II: Spontaneous bleeding in addition to the manifestations of Grade I patients, usually in the form of skin and/or other hemorrhages; Grade III: Circulatory failure manifested by rapid and weak pulse, narrowing of pulse pressure (20 mmHg or less) or hypotension, with the presence of cold clammy skin and restlessness; and Grade IV: Profound shock with undetectable blood pressure and pulse


  7. Number of Clinically Severe VCD Cases During the Active Phase Due to Any Serotype Following Injection With Either CYD Dengue Vaccine or a Placebo. [ Time Frame: Day 0 up to 13 months post-injection 3 ]
    The severity of VCD cases was assessed by an Independent Data Monitoring Committee using pre-defined standardized criteria and base on a medical review.

  8. Number of Participants With Solicited Injection Site Reactions Following Any and Each Injection With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Within 7 days after injection ]
    Solicited injection site reactions: Pain, Erythema, and Swelling. Grade 3 reactions (2-11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥50 mm. Grade 3 Solicited injection site reactions (12-14 years): Pain, Significant, prevents daily activity; Erythema and Swelling, >100 mm.

  9. Number of Participants With Systemic Reactions Following Any and Each Injection With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Within 14 days after injection ]
    Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Asthenia. Grade 3 reactions: Fever, ≥39°C; Headache, Malaise, Myalgia, and Asthenia, Significant, prevents daily activity.



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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT01373281


Locations
Indonesia
Denpasar, Bali, Indonesia, 80114
Bandung, West Java, Indonesia, 40161
Jakarta, Indonesia, 10430
Malaysia
Kuala Lumpur, Malaysia, 50586
Pulau Pinang, Malaysia, 10450
Philippines
Cebu City, Philippines, 6000
San Pablo City, Philippines, 4000
Thailand
Nai Muang, Kamphaeng Phet Province, Thailand, 6200
Ban Pong, Ratchaburi Province, Thailand, 70110
Photharam, Ratchaburi Province, Thailand, 70120
Vietnam
Long Xuyên, An Giang Province, Vietnam
Mỹ Tho, Tien Giang Province, Vietnam
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01373281     History of Changes
Other Study ID Numbers: CYD14
UTN: U1111-1116-4957 ( Other Identifier: WHO )
2014-001708-24 ( EudraCT Number )
First Posted: June 14, 2011    Key Record Dates
Results First Posted: November 16, 2015
Last Update Posted: October 9, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data (IPD) and supporting clinical documents are available for request at www.clinicalstudydatarequest.com. While making information available we continue to protect the privacy of the participants in our clinical trials and to remove commercially confidential information (CCI). Details on Data Sharing criteria and process for requesting access can be found at this web address: Clinicalstudydatarequest.com/Sanofi.

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
Dengue
Dengue fever
Dengue Hemorrhagic Fever
CYD dengue vaccine
Flavivirus

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