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

NCT00777257 | Completed Phase 4 Results DMC

• 1 other identifier: MTA21
• Study Type: interventional
• Target: 1,345
• Locations: 1 country
• Sites: 20

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.

Conditions

Meningitis; Meningococcemia; Pertussis; Tetanus; Diphtheria

Keywords

Meningitis; Meningococcemia; Pertussis; Neisseria meningitidis; Tetanus; Diphtheria

Outcome Measures

Primary Outcomes (3)

• 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 Diphtheria and Tetanus Antibodies at Baseline and on Day 28 Post-vaccination With Tdap Vaccine.

  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.

  Day 0 and Day 28 Post-vaccination

Secondary Outcomes (1)

• 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

Study Arms (3)

Study Group A

EXPERIMENTAL

Tdap vaccine + placebo concomitantly on Day 0; Menactra® vaccine 28 days later

Biological: T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.

Study Group B

EXPERIMENTAL

Tdap vaccine + Menactra® vaccine concomitantly on Day 0; placebo 28 days later

Biological: Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj.

Study Group C

EXPERIMENTAL

Menactra® vaccine + placebo concomitantly on Day 0; Tdap vaccine 28 days later

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap

Interventions

T dap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. BIOLOGICAL

Day 0: 0.5 mL (T dap)+ Placebo, Intramuscular; Day 28: 0.5 mL (Menactra®) Intramuscular

Also known as: ADACEL®, Menactra®, Sterile Buffered 0.9% Sodium Chloride

Study Group A

Tdap + Meningococcal Polysaccharide Diphtheria Toxoid Conj. BIOLOGICAL

Day 0: 0.5 mL (T dap) + 0.5 mL (Menactra®) Intramuscular; Day 28: Placebo 0.5 mL Intramuscular

Also known as: Menactra®, Adacel®, Sterile Buffered 0.9% Sodium Chloride

Study Group B

Meningococcal Polysaccharide Diphtheria Toxoid Conj. + T dap BIOLOGICAL

Day 0: 0.5 mL (Menactra®)+0.5 mL Placebo, Intramuscular; Day 28: 0.5 mL (T dap) Intramuscular

Also known as: Menactra®, Adacel®, Sterile Buffered 0.9% Sodium Chloride

Study Group C

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy as determined by medical history and physical examination.
• Aged ≥ 11 to 17 years at the time of study vaccination on Day 0.
• Informed consent form that has been approved by the Institutional Review Board (IRB) signed by the parent or legal guardian.
• Informed assent form that has been approved by the IRB signed by the subject.
• Subject (female) agrees to use measures to prevent pregnancy during the study.

You may not qualify if:

• Serious chronic disease (i.e. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.).
• Known or suspected impairment of immunologic function.
• Acute medical illness with or without fever within the last 72 hours or an oral temperature ≥ 100.4°F (≥ 38.0°C) at the time of enrolment.
• History of documented invasive meningococcal disease or previous meningococcal vaccination.
• History of documented infection with Bordetella pertussis, Clostridium tetani, or Corynebacterium diphtheriae or vaccination with any tetanus, diphtheria or pertussis vaccine within the previous 5 years.
• Received either immune globulin or other blood products within the last 3 months; or received injected or oral corticosteroids, or other immunomodulator therapy, within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting \<7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last 2 weeks prior to enrolment.
• Received antibiotic therapy within the 72 hours prior to vaccination on Day 0.
• Received any vaccine 28 days prior to the 1st study vaccination or scheduled to receive any vaccination during the course of the study.
• Suspected or known hypersensitivity to either of the two study vaccines or their components.
• Unavailable for the entire study period, or unable to attend the scheduled visits or to comply with the study procedures.
• Enrolled in another clinical trial.
• Diagnosed with any condition, which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
• For all females, a positive or equivocal urine pregnancy test at time of study vaccination.
• Nursing mothers.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (20)

Unknown Facility

Jonesboro, Arkansas, 72401, United States

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Little Rock, Arkansas, 72205, United States

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Boulder, Colorado, 80303, United States

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Marietta, Georgia, 30062, United States

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Woodstock, Georgia, 30189, United States

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Bardstown, Kentucky, 40004, United States

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Baltimore, Maryland, 21201, United States

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Woburn, Massachusetts, 01801, United States

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Albuquerque, New Mexico, 87108, United States

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Syracuse, New York, 13210, United States

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Raleigh, North Carolina, 27609, United States

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Sylva, North Carolina, 28779, United States

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Akron, Ohio, 44308, United States

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Cleveland, Ohio, 44118, United States

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Columbus, Ohio, 43205, United States

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Dayton, Ohio, 45404, United States

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Pittsburgh, Pennsylvania, 15241, United States

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Sellersville, Pennsylvania, 18960, United States

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Kingsport, Tennessee, 37660, United States

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Spokane, Washington, 99202, United States

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Related Links

• Related Info

MeSH Terms

Conditions

Meningitis; Meningococcal Infections; Whooping Cough; Tetanus; Diphtheria

Interventions

adacel; Meningococcal Vaccines; Sodium Chloride

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Bordetella Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Monitor

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2008
• First Posted: October 22, 2008
• Study Start: April 1, 2005
• Primary Completion: March 1, 2007
• Study Completion: September 1, 2007
• Last Updated: February 14, 2014
• Results First Posted: December 31, 2009

Record last verified: 2014-01

Locations

US (20)