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 ]
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