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Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers

NCT00483574 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1378

Last updated 2016-05-16

Study results available
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Summary

This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US.

Safety Objective:

To describe the safety profile of two doses of Menactra® Vaccine.

Conditions

Interventions

BIOLOGICAL

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

0.5 mL, IM at age 9 and 12 months

BIOLOGICAL

Measles-mumps-rubella-varicella vaccine

0.5 mL, intramuscular at 12 months of age

BIOLOGICAL

Routine paediatric vaccine - Pneumococcal conjugate (PCV)

0.5 mL, Intramuscular at age 12 months

BIOLOGICAL

Routine paediatric vaccine - Hepatitis A

0.5 mL, Intramuscular at age 12 months

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-01-31
Completion
2009-04-30

Countries

  • United States
  • Chile

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 NCT00483574 on ClinicalTrials.gov