Clinical Trial: Study of Menactra® in US Adolescents When Administered Concomitantly With Tdap Vaccine

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Immunogenicity and Safety of Meningococcal (Groups A, C, Y, and W-135) Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Adolescents in the US When Administered Concomitantly With Tetanus Toxoid

Brief Summary:

The purpose of this study was to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and Tdap vaccine in adolescents aged 11 to 17 years.

Primary Objective:

To determine whether concomitant administration of two vaccines, Tdap and Menactra®, induces antibody responses that are similar to those observed when each vaccine is given separately.

Secondary Objective:

To compare the rates of injection site reactions at the Tdap injection site after Tdap and Menactra® vaccines are administered concomitantly to the corresponding rates of reactions when Tdap vaccine is administered alone.


Detailed Summary:
Sponsor: Sanofi Pasteur, a Sanofi Company

Current Primary Outcome:

  • Percentage of Participants With at Least a 4-fold Rise in Meningococcal Antibody Titer From Baseline (Day 0) to Day 28 Post-vaccination With Menactra® Vaccine. [ Time Frame: Day 0 to Day 28 post-vaccination ]
  • Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. [ Time Frame: Day 0 and Day 28 post-vaccination ]
  • Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine. [ Time Frame: Day 0 and Day 28 Post-vaccination ]


Original Primary Outcome: To provide information concerning immune response of Menactra® after concomitant vaccination with Tdap. [ Time Frame: 28 days post-vaccination ]

Current Secondary Outcome: Percentage of Participants Reporting Solicited Injections Site and Systemic Reactions Following Concomitant Administration of Tdap With Placebo; Menactra® With Tdap; and Menactra® With Placebo, Respectively. [ Time Frame: 0 to 7 days post-vaccination ]

Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.


Original Secondary Outcome: To provide information concerning the safety after concomitant administration of Menactra® with Tdap. [ Time Frame: 28 days post-vaccination and entire study period ]

Information By: Sanofi

Dates:
Date Received: October 21, 2008
Date Started: April 2005
Date Completion:
Last Updated: January 21, 2014
Last Verified: January 2014