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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Immunogenicity and Safety of CYD Dengue Vaccine in Healthy Children and Adolescents Aged 9 to 16 Years in South America

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.

Detailed Summary: 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.
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome:

  • 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).
  • 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.
  • 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

    Original Primary Outcome:

    • Information concerning the immunogenicity of CYD dengue vaccine after primary vaccination. [ Time Frame: 28 days post-vaccination ]
    • 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 ]


    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Sanofi

    Dates:
    Date Received: August 20, 2010
    Date Started: August 2010
    Date Completion:
    Last Updated: September 25, 2016
    Last Verified: September 2016