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Clinical Trials/NCT00483574
NCT00483574
Completed
Phase 3

Safety Study of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered With Other Pediatric Vaccines to Healthy Toddlers

Sanofi Pasteur, a Sanofi Company0 sites1,378 target enrollmentMay 2007
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ConditionsMeningococcal MeningitisMeaslesMumpsRubellaVaricella

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Meningococcal Meningitis
Sponsor
Sanofi Pasteur, a Sanofi Company
Enrollment
1378
Primary Endpoint
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 2007
End Date
April 2009
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.

Time Frame: Day 0 to 7 Post-vaccination

Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability

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