Clinical Trial: Study of Yellow Fever Vaccine Administered With Tetravalent Dengue Vaccine in Healthy Toddlers

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

Official Title: Immunogenicity and Safety of Yellow Fever Vaccine (Stamaril®) Administered Concomitantly With Tetravalent Dengue Vaccine in Healthy Toddlers at 12-13 Months of Age in Colombia and Peru

Brief Summary:

The study is designed to evaluate whether the first CYD dengue vaccination can be administered concomitantly with Stamaril® yellow fever vaccine during the same day and visit, but at 2 different sites of administration.

Primary Objective:

  • To demonstrate the non-inferiority of the immune response against Yellow Fever in flavivirus (FV)-naïve subjects at baseline receiving one dose of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine compared to subjects receiving one dose of Stamaril vaccine concomitantly with placebo.

Secondary Objectives:

  • To assess the non-inferiority of yellow fever immune response 28 days post-Stamaril vaccination based on seroconversion rates regardless of the FV status of subjects at baseline.
  • To describe the safety of Stamaril vaccine administered concomitantly with the first dose of CYD dengue vaccine, or Stamaril administered concomitantly with placebo.
  • To describe the safety of CYD dengue vaccine after the first dose of CYD dengue vaccine administered concomitantly with Stamaril vaccine or CYD vaccine administered alone.

Detailed Summary: All participants will receive a total of 8 injections during the study. Vaccine immunogenicity assessments for dengue neutralizing antibodies will be performed in a randomized subset of participants. All participants will be followed-up for safety during the study and for 6 months after the last CYD dengue vaccination.
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: Information on the antibody to yellow fever virus post Stamaril vaccination [ Time Frame: 28 days post-vaccination ]

Yellow Fever antibodies will be determined by a yellow fever virus plaque reduction neutralization test (YF PRNT50) assay


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Information concerning the immunogenicity of CYD dengue vaccine post vaccination [ Time Frame: 28 days post-CYD dengue vaccination ]
    Dengue antibodies will be determined by a dengue virus plaque reduction neutralization test (PRNT50) assay
  • Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post-vaccination with yellow fever and CYD dengue vaccines [ Time Frame: Day 0 up to 6 months post-final vaccination ]
    Solicited injection site reactions: Tenderness, Erythema, and Swelling; Solicited Systemic Reactions: Fever (temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: September 7, 2011
Date Started: September 2011
Date Completion:
Last Updated: April 1, 2014
Last Verified: April 2014