Clinical Trial: Study of a Booster Injection of Pentaxim™ Vaccine Administered With Dengue Vaccine in Healthy Toddlers

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

Official Title: Immunogenicity and Safety of a Booster Injection of DTaP-IPV//Hib (Pentaxim™) Administered Concomitantly With Tetravalent Dengue Vaccine in Healthy Toddlers Aged 15 to 18 Months in Mexico

Brief Summary:

The aim of the study is to assess whether the second CYD dengue vaccination could be administered concomitantly with the booster vaccination of a pediatric combination vaccine (Pentaxim™) during the same day and visit but in 2 different sites of administration.

Primary Objective:

  • To demonstrate the non-inferiority of the antibody response against all antigens (diphtheria, tetanus, pertussis, polio and Hib) in participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine compared to subjects receiving one booster dose of Pentaxim™ vaccine administered concomitantly with placebo.

Secondary Objectives:

  • To describe the safety of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine, or administered concomitantly with placebo.
  • To describe the safety of the CYD dengue vaccine in all subjects after each dose.
  • To describe the antibody response to each dengue virus serotype (post-Dose 2 and post-Dose 3) after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim vaccine or administered alone.
  • To describe the antibody response to each dengue virus serotype post-Dose 2 and post-Dose 3 in all subjects.

Detailed Summary: Participants will require 8 or 9 clinic visits and will receive a total of 7 injections. The dengue post-vaccinal viremia will be assessed at Visit 2 from a subset of toddlers. The dengue immunogenicity will be assessed 28 days after CYD dengue dose 2 and dose 3 from a subset of toddlers. All participants will be followed-up for safety after each vaccine dose and for 6 months after the last dengue vaccination.
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome: Information on the antibody to diphtheria toxoid, tetanus toxoid, pertussis, Filamentous haemagglutinin, polyribosylribitol phosphate (PRP) and polio post-Pentaxim booster vaccination [ Time Frame: 28 days post-Pentaxim vaccination ]

Levels of antibodies to diphtheria toxoid, tetanus toxoid, pertussis toxoid (PT), filamentous hemagglutinin (FHA), polyribosylribitol phosphate (PRP) and polio antigens will be measured post-Pentaxim booster vaccination.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Information concerning the safety in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events post vaccination with Pentaxim and CYD vaccines. [ Time Frame: 28 days post-vaccination ]
    Solicited injection site reactions: Tenderness, Erythema, Swelling, and Extensive Swelling of Vaccinated Limb; Solicited Systemic reactions: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of appetite, and Irritability.
  • Information concerning the immunogenicity of CYD dengue vaccine post-vaccination [ Time Frame: 28 days post-dose 2 and dose 3 ]
    Neutralizing antibody levels against each of the 4 dengue virus serotype strains contained in the CYD dengue vaccine will be measured in sera collected from a randomized subset of participants using the dengue plaque reduction neutralization test (PRNT).


Original Secondary Outcome: Same as current

Information By: Sanofi

Dates:
Date Received: August 3, 2011
Date Started: July 2011
Date Completion:
Last Updated: January 9, 2015
Last Verified: January 2015