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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01187433
First received: August 20, 2010
Last updated: September 25, 2016
Last verified: September 2016

August 20, 2010
September 25, 2016
August 2010
October 2012   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    Geometric mean titer ratios were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
  • 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 ] [ Designated as safety issue: No ]
    Geometric mean titers were assessed using the Dengue Plaque Reduction Neutralization Test (PRNT).
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • 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 ] [ Designated as safety issue: No ]
    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.
  • Information concerning the immunogenicity of CYD dengue vaccine after primary vaccination. [ Time Frame: 28 days post-vaccination ] [ Designated as safety issue: No ]
  • Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events and serious adverse events post-vaccination with CYD dengue vaccine. [ Time Frame: 0-14 days post-vaccination and entire study duration ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01187433 on ClinicalTrials.gov Archive Site
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Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America
Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America

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.
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Dengue
  • Dengue Hemorrhagic Fever
  • Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
    0.5 mL, Subcutaneous (SC)
    Other Name: CYD Dengue Vaccine
  • 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
  • Experimental: Dengue Vaccine Group
    Participants will receive Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus vaccine
    Intervention: Biological: Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus
  • Placebo Comparator: Control Group
    Participants will receive a placebo, NaCl 0.9%.
    Interventions:
    • Biological: NaCl 0.9%
    • Biological: Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed
    • Biological: Meningococcal A+C vaccine
Dayan GH, Garbes P, Noriega F, Izoton de Sadovsky AD, Rodrigues PM, Giuberti C, Dietze R. Immunogenicity and safety of a recombinant tetravalent dengue vaccine in children and adolescents ages 9-16 years in Brazil. Am J Trop Med Hyg. 2013 Dec;89(6):1058-65. doi: 10.4269/ajtmh.13-0304.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
December 2012
October 2012   (final data collection date for primary outcome measure)

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.
Both
9 Years to 16 Years   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01187433
CYD30, UTN: U1111-1111-6073
Yes
Yes
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.
Sanofi Pasteur, a Sanofi Company
Sanofi Pasteur, a Sanofi Company
Not Provided
Study Director: Medical Director Sanofi Pasteur Inc.
Sanofi
September 2016

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