Clinical Trial: Study of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Adacel® in Healthy Subjects Aged 9 to 60 Years in the Philippines

Brief Summary:

The aim of the study is investigate the immunogenicity and safety of CYD dengue vaccine and Tdap vaccine when both vaccines are administered concomitantly or sequentially.

Primary Objectives:

• To demonstrate the non-inferiority of the humoral immune response to the Tdap booster dose concomitantly administered with the first dose of CYD dengue vaccine as compared to sequential administration, measured 28 days after Tdap booster dose
• To demonstrate the non-inferiority of the humoral immune response to the first dose of CYD dengue vaccine concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the first dose of CYD dengue vaccine.

Secondary Objectives:

• To demonstrate the non-inferiority of the humoral immune response of 3 doses of CYD dengue vaccine with the first dose concomitantly administered with Tdap as compared to sequential administration, measured 28 days after the third dose of CYD dengue vaccine.
• To describe the humoral immune response at baseline and 28 days after the first and third doses of CYD dengue vaccine, in each and any group.
• To describe the humoral immune response of Tdap vaccine at baseline and 28 days after concomitant administration with the first dose of CYD dengue vaccine as compared to the sequential administration, in each and any group.
• To describe the safety of the CYD dengue vaccine and of the Tdap booster dose after each and any injection in each group.

Detailed Summary:

All participants will receive the CYD dengue vaccine according to a 3-dose schedule to be administered 6 months apart, with the first dose of CYD dengue vaccine administered either concomitantly or sequentially with a booster dose of the Tdap vaccine, Adacel®.

They will be assessed for immunogenicity and safety.

Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome:

• Antibody concentrations against pertussis antigens (Pertussis toxoid, Filamentous hemagglutinin, Pertactin, and Fimbriae 2+3) 28 days after the dose of Tdap vaccine administered concomitantly or sequentially with CYD Dengue vaccine [ Time Frame: 28 Days post the dose of Tdap vaccine ]
  Pertussis antibodies will be measured by enzyme linked immunosorbent assay (ELISA)
• Percentage of subjects with seroprotection against Diphtheria and Tetanus antigens following vaccination with Tdap vaccine administered either concomitantly or sequentially with CYD Dengue vaccine [ Time Frame: 28 Days post the dose of Tdap vaccine ]
  Tetanus antibodies will be measured by enzyme linked immunosorbent assay (ELISA), Diphtheria antibodies will be measured by Micrometabolic Inhibition Test Toxin Neutralization assay (MIT TNA)
• Neutralizing antibody titers against each dengue virus serotype at baseline and 28 days after the first CYD Dengue injection given concomitantly or sequentially with Tdap vaccine [ Time Frame: Day 28 post first CYD Dengue vaccine injection ]
  Neutralizing antibody levels against each dengue virus serotype will be measured using dengue 50% plaque reduction neutralization test (PRNT50)

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Neutralizing antibody titers against each dengue virus serotype at baseline and 28 days after the third CYD Dengue injection given concomitantly or sequentially with Tdap vaccine [ Time Frame: Day 28 post the third CYD Dengue vaccine injection ]
  Neutralizing antibody levels against each dengue virus serotype will be measured using dengue 50% plaque reduction neutralization test (PRNT50)
• Antibody concentrations against Tetanus, Diphtheria, and Pertussis Antigens Before and 28 Days After the Dose of Tdap Vaccine [ Time Frame: Day O and Day 28 Post Tdap Vaccine Injection ]
  Pertussis and tetanus Antibodies will be measured by enzyme linked immunosorbent assay (ELISA) Tetanus antibodies will be measured by and by Micrometabolic Inhibition Test Toxin Neutralization assay (MIT TNA).
• Number of participants reporting solicited injection site reactions, solicited systemic reactions, unsolicited adverse events, and serious adverse events occurring during trial [ Time Frame: Day 0 up to 19 months post vaccination ]
  Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Asthenia
• Neutralizing antibody titers against each of the four dengue virus serotype at baseline and 28 days after the first and third CYD Dengue injection given concomitantly or sequentially with Tdap vaccine [ Time Frame: Day 28 post first and third CYD Dengue vaccine injection ]
  Neutralizing antibody levels against each dengue virus serotype will be measured using dengue 50% plaque reduction neutralization test (PRNT50)

Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: December 12, 2016
Date Started: December 2016
Date Completion: March 2019
Last Updated: December 12, 2016
Last Verified: December 2016