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

Phase 4

Completed

• Conditions: Meningitis; Meningococcemia; Pertussis; Tetanus; Diphtheria
• Interventions: Biological: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.; Biological: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.; Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap

• Registration Number: NCT00777257
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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 Description

Not available

Study Timeline

• Study Start: 2005-04
• Primary Completion: 2007-03
• Study Completion: 2007-09
• Study First Submitted: 2008-10-21
• Study First Submitted QC: 2008-10-21
• Study First Posted: 2008-10-22
• Results First Submitted: 2009-09-24
• Results First Submitted QC: 2009-12-01
• Results First Posted: 2009-12-31
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-21
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1345

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Study Group A	T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.	Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later
Study Group B	Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.	Tdap vaccine + Menactra® vaccine concomitantly on Day 0; placebo 28 days later
Study Group C	Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap	Menactra® vaccine + placebo concomitantly on Day 0; Tdap vaccine 28 days later

Primary Outcome Measures

Name	Time	Method
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.	Day 0 to Day 28 post-vaccination
Geometric Mean Concentrations (GMCs) of Pertussis Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.	Day 0 and Day 28 Post-vaccination
Geometric Mean Concentrations (GMCs) of Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.	Day 0 and Day 28 post-vaccination

Secondary Outcome Measures

Name	Time	Method
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.	0 to 7 days post-vaccination	Solicited injection sites reactions: Erythema, swelling, and pain. Solicited systemic reactions: Fever (temperature), headache, malaise, and myalgia.