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