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

Phase 3

Completed

• Conditions: Varicella; Meningococcal Meningitis; Mumps; Measles; Rubella
• Interventions: Biological: Measles-mumps-rubella-varicella vaccine; Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV); Biological: Routine paediatric vaccine - Hepatitis A

• Registration Number: NCT00483574
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-06-06
• Study First Submitted QC: 2007-06-06
• Study First Posted: 2007-06-07
• Primary Completion: 2009-01
• Study Completion: 2009-04
• Disposition First Submitted: 2010-03-31
• Disposition First Submitted QC: 2010-03-31
• Disposition First Posted: 2010-04-02
• Results First Submitted: 2011-05-10
• Results First Submitted QC: 2011-06-08
• Results First Posted: 2011-07-06
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1378

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Menactra® and Routine Pediatric Vaccines	Measles-mumps-rubella-varicella vaccine	Participants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate \[PCV\], and hepatitis A \[HepA\]) at age 12 months.
Group 1: Menactra® and Routine Pediatric Vaccines	Routine paediatric vaccine - Hepatitis A	Participants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate \[PCV\], and hepatitis A \[HepA\]) at age 12 months.
Group 1: Menactra® and Routine Pediatric Vaccines	Routine paediatric vaccine - Pneumococcal conjugate (PCV)	Participants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate \[PCV\], and hepatitis A \[HepA\]) at age 12 months.
Group 2: Routine Pediatric Vaccines	Routine paediatric vaccine - Hepatitis A	Participants received routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate\[PCV\], and hepatitis A \[HepA\]) at age 12 months.
Group 2: Routine Pediatric Vaccines	Measles-mumps-rubella-varicella vaccine	Participants received routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate\[PCV\], and hepatitis A \[HepA\]) at age 12 months.
Group 2: Routine Pediatric Vaccines	Routine paediatric vaccine - Pneumococcal conjugate (PCV)	Participants received routine pediatric vaccines (measles-mumps-rubella-varicella \[MMRV: ProQuad\], pneumococcal conjugate\[PCV\], and hepatitis A \[HepA\]) at age 12 months.

Primary Outcome Measures

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