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

Summary

The aim of the study was 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 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 Haemophilus influenzae type b (Hib)) in participants receiving one booster dose of Pentaxim™ vaccine administered concomitantly with the second dose of CYD dengue vaccine compared to participants 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 after the second dose of CYD dengue vaccine administered concomitantly with Pentaxim™ vaccine (at Visit 05) or administered alone (at Visit 06).
* To describe the safety of the CYD dengue vaccine in all participants 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 (at Visit 05) or administered alone (at Visit 06).
* To describe the antibody response to each dengue virus serotype post-Dose 2 and post-Dose 3.

Conditions

• Dengue
• Dengue Hemorrhagic Fever

Interventions

BIOLOGICAL

Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus

0.5 mL, subcutaneous at age 9 to 12, 15 to 18 and 21 to 24 months.

BIOLOGICAL

DTaP IPV//Hib vaccine

0.5 mL, intramuscular

BIOLOGICAL

Placebo

0.5 mL, subcutaneous

BIOLOGICAL

Measles, mumps, and rubella vaccine

0.5 mL, subcutaneous

BIOLOGICAL

Pneumococcal vaccine

0.5 mL, intramuscular

BIOLOGICAL

Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus

0.5 mL, subcutaneous at age 9 to 12, 16 to 19 and 21 to 24 months

BIOLOGICAL

DTaP IPV//Hib vaccine

0.5 mL, intramuscular

BIOLOGICAL

Placebo

0.5 mL, subcutaneously

BIOLOGICAL

Measles, mumps, and rubella vaccine

0.5 mL, subcutaneous

BIOLOGICAL

Pneumococcal vaccine

0.5 mL, intramuscular

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company

  lead INDUSTRY

Principal Investigators

• Medical Director · Sanofi Pasteur SA

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

9 Months

Max Age

12 Months

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-07-18

Primary Completion

2014-02-04

Completion

2014-04-30

Countries

• Mexico

Study Locations