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Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America

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: NCT01187433
Recruitment Status : Completed
First Posted : August 24, 2010
Results First Posted : November 11, 2016
Last Update Posted : November 11, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description
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Brief Summary:

The purpose of this study is to generate immunogenicity and safety data in preparation for efficacy studies in Latin America.

Primary Objectives:

  • To describe the immune response to dengue viruses before and after each vaccination with CYD dengue vaccine.
  • To evaluate the safety of each vaccination with CYD dengue vaccine.

Condition or disease Intervention/treatment Phase
Dengue Dengue Hemorrhagic Fever Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus Biological: NaCl 0.9% Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed Biological: Meningococcal A+C vaccine Phase 2

Detailed Description:
Participants in the Dengue Vaccine Group will receive 3 vaccinations with CYD Dengue vaccine. Participants in the Control Group will receive placebo vaccinations for the first 2 vaccinations, followed by tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed (ADACEL®) (in Venezuela) or Meningococcal A+C vaccine (in Brazil) as a way of providing therapeutic benefit to the participants in the control group.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America
Study Start Date : August 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dengue

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dengue Vaccine Group
Participants will receive Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus vaccine
 Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
0.5 mL, Subcutaneous (SC)
Other Name: CYD Dengue Vaccine
Placebo Comparator: Control Group
Participants will receive a placebo, NaCl 0.9%.
 Biological: NaCl 0.9%
0.5 mL, Subcutaneous

Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed
0.5 mL, Intramuscular
Other Name: ADACEL®

Biological: Meningococcal A+C vaccine
0.5 mL, Intramuscular


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Before and 28 days after each injection ]
    Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).

  2. Percentage of Flavivirus Immune Participants With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Before and 28 days after each injection ]
    Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.

  3. Percentage of Flavivirus Naïve Subjects With Seropositivity Against Each Serotype With the Parental Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Before and 28 Days after each injection ]
    Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.

  4. Percentage of Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Before and 28 days after each injection ]
    Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).

  5. Percentage of Flavivirus Immune Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Before and 28 days after each injection ]
    Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.

  6. Percentage of Flavivirus Naïve Subjects With Seropositivity Against At Least 1, 2, 3, or 4 Parental Dengue Virus Serotypes Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Before and 28 days after each injection ]
    Seropositivity was defined as participants achieving neutralizing antibody titers ≥10 (1/dil) against each serotype and was assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.

  7. Geometric Mean Titer Ratios (GMTRs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Before and 28 days after each injection ]
    Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).

  8. Geometric Mean Titers (GMTs) Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Before and 28 days after each injection ]
    Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).

  9. Geometric Mean Titers (GMTs) of Flavivirus Immune Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Before and 28 days after each injection ]
    Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus immune subjects at baseline are defined as those subjects with ≥10 (1/dil) for at least 1 serotype with the parental dengue virus strain or for the yellow fever titer.

  10. Geometric Mean Titer Ratios (GMTRs) of Flavivirus naïve Subjects Against Each Serotype With the Parental of Dengue Virus Strains Before and After Vaccinations With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Before and 28 days after each injection ]
    Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT). Flavivirus naïve subjects at baseline are defined as those subjects with <10 (1/dil) for all serotypes with parental dengue virus strains and for yellow fever titer.

  11. Percentage of Participants Reporting Solicited Injection-Site and Systemic Reactions Following Any and Each Vaccination With Either CYD Dengue Vaccine or a Placebo [ Time Frame: Day 0 up to Day 14 post each vaccination ]
    Injection-site reactions: Pain, Erythema, and Swelling. Systemic reactions: Fever, Headache, Malaise, Myalgia, and Asthenia. Grade 3 Injection-site reactions (9 to 11 years): Pain, Incapacitating, unable to perform usual activities; Erythema and Swelling, ≥5 cm. Grade 3 Injection site reactions (≥12 years): Pain, Significant; prevents daily activity; Erythema and Swelling, >10 cm. Grade 3 Systemic reactions: Fever, ≥39˚C; Headache, Malaise, Myalgia, and Asthenia, Significant; prevents daily activity.


Eligibility Criteria
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Ages Eligible for Study:   9 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria :

  • Aged 9 to 16 years on the day of inclusion
  • Participant in good health, based on medical history and physical examination
  • Provision of assent form/informed consent form signed by the participant and by the parent(s) or another legally acceptable representative
  • Participant and parent(s)/legally acceptable representative(s) able to attend all scheduled visits and to comply with all trial procedures
  • For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) for at least 4 weeks prior to first vaccination until at least 4 weeks after the last vaccination

Exclusion Criteria :

  • Personal or family history of thymic pathology (thymoma), thymectomy, or myasthenia
  • For a female participant of child-bearing potential, known pregnancy or positive urine pregnancy test at Visit 1
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
  • Breast-feeding woman
  • Planned participation in another clinical trial during the present trial period
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy
  • Known systemic hypersensitivity to any of the components of any of the trial vaccines or history of a life-threatening reaction to any of the trial vaccines or to a vaccine containing any of the same substances
  • Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
  • Current alcohol abuse or drug addiction that may interfere with the participant's ability to comply with trial procedures
  • Receipt of blood or blood-derived products in the preceding 3 months that might interfere with the assessment of immune response
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination
  • Planned receipt of any vaccine in the 4 weeks following the first trial vaccination
  • Participant deprived of freedom by administrative or court order, or in an emergency setting, or hospitalized without his/her consent
  • Febrile illness (temperature ≥ 38.0 ºC) or moderate or severe acute illness/infection on the day of vaccination, according to Investigator judgment
  • Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination
  • Severe diseases with or without fever, convulsions or neurological abnormalities without treatment or in progression.
Contacts and Locations
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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): NCT01187433


Locations
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Brazil
Vitória, Brazil, ES, 29040-091
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
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Study Director: Medical Director Sanofi Pasteur Inc.
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sanofi Pasteur, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01187433    
Other Study ID Numbers: CYD30
UTN: U1111-1111-6073 ( Other Identifier: WHO )
First Posted: August 24, 2010    Key Record Dates
Results First Posted: November 11, 2016
Last Update Posted: November 11, 2016
Last Verified: September 2016
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 hemorrhagic fever
CYD Dengue Vaccines
Additional relevant MeSH terms:
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Dengue
Hemorrhagic Fevers, Viral
Severe Dengue
Arbovirus Infections
Virus Diseases
Flavivirus Infections
 Flaviviridae Infections
RNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs