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Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers

NCT00422292 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1664

Last updated 2016-04-14

Study results available
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Summary

This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.

Primary Objectives:

* To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine.
* To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine.

Observational Objectives:

Safety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination\[s\]) in subjects in the study groups.

Immunogenicity:

\- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.

Conditions

Interventions

BIOLOGICAL

Meningococcal Polysaccharide Diphtheria Conjugate Vaccine

0.5 mL dose, intramuscular (IM)

BIOLOGICAL

Meningococcal Polysaccharide Diphtheria Conjugate Vaccine

0.5 mL dose, IM

BIOLOGICAL

Meningococcal Polysaccharide Diphtheria Conjugate Vaccine

0.5 Ml dose, IM

BIOLOGICAL

Measles, Mumps, Rubella and Varicella

0.5 mL dose, SC

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
9 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2009-01-31
Completion
2009-04-30

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00422292 on ClinicalTrials.gov