Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®

NCT00355121 | Completed Phase 2 Results

• 1 other identifier: MTA43
• Study Type: interventional
• Target: 882
• Locations: 1 country
• Sites: 26

Brief Summary

The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone. Safety: To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.

Conditions

Meningococcal Meningitis; Tetanus; Diphtheria; Pertussis; Poliomyelitis

Keywords

Meningococcal meningitis; Tetanus; Diphtheria; Pertussis; Poliomyelitis; Neisseria meningitidis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination

  Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.

  Day 30 post-vaccination (Visit 1)

• Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.

  Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)

  Day 30 post-vaccination (Visit 1)

Secondary Outcomes (3)

• Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1

  Day 30 post-vaccination 1

• Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination

  Day 30 post-vaccination

• Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine

  Day 0 through Day 7 post-vaccination at Visit 1

Other Outcomes (3)

• Geometric Mean Titers Against Poliovirus After IPOL Vaccination.

  Day 30 post-vaccination

• Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1

  Day 0 through Day 7 post-vaccination

• Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2

  Day 0 through Day 7 post-vaccination

Study Arms (3)

Group 1

EXPERIMENTAL

DAPTACEL® + IPOL on Day 0 and Menactra on Day 30

Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Group 2

EXPERIMENTAL

DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30

Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Group 3

EXPERIMENTAL

Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30

Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Interventions

Polysaccharide Diphtheria Toxoid Conjugate Vaccine BIOLOGICAL

0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)

Also known as: Menactra®, DAPTACEL®, IPOL

Group 1

Eligibility Criteria

• Age: 4 Years - 7 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 4 to \< 7 years at the time of study vaccination on Day 0.
• Informed consent form that has been approved by the Institutional Review Board (IRB) and signed/dated by the parent or legal guardian.
• Previous documented vaccination history of 4th dose diphtheria, tetanus and acellular pertussis (DTaP) series.

You may not qualify if:

• Serious chronic disease (e.g. cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, hematologic)
• Known or suspected impairment of immunologic function
• Acute medical illness with or without fever within the last 72 hours or temperature ≥ 100.4°F (≥ 38°C) at the time of enrollment
• History of documented invasive meningococcal disease or previous meningococcal vaccination
• Received a 5th dose vaccination with any tetanus, diphtheria or pertussis vaccine, or 4th dose of IPV prior to this study.
• 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 enrollment.
• Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw.
• Suspected or known hypersensitivity to any of the study vaccine components, history of serious or life-threatening reaction to the trial vaccines or a vaccine containing the same substances.
• Thrombocytopenia or a bleeding disorder contraindicating IM vaccination.
• 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 physician investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
• Received any other vaccine 30 days prior to the first study vaccination or scheduled to receive any vaccination during the course of the study.
• Personal or family history of Guillain-Barré Syndrome (GBS).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (26)

Unknown Facility

Little Rock, Arkansas, 72205, United States

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Boulder, Colorado, 80304, United States

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Atlanta, Georgia, 30322, United States

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Layton, UT 84041, Georgia, 30062, United States

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Bardstown, Kentucky, 40004, United States

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Woburn, Massachusetts, 01801, United States

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Bridgeton, Missouri, 63044, United States

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St Louis, Missouri, 63141, United States

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Albuquerque, New Mexico, 87108, United States

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Rochester, New York, 14620, United States

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Syracuse, New York, 13210, United States

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Akron, Ohio, 44308, United States

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Cincinnati, Ohio, 45229, United States

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Columbus, Ohio, 43205, United States

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University Heights, Ohio, 44118, 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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Layton, Utah, 84041, United States

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Ogden, Utah, 84405, United States

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Pleasant Grove, Utah, 84062, United States

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Provo, Utah, 84604, United States

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Salt Lake City, Utah, 84123, United States

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South Jordan, Utah, 84095, United States

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Norfolk, Virginia, 23510, United States

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Spokane, Washington, 99220, United States

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Related Links

• Related Info

MeSH Terms

Conditions

Meningitis, Meningococcal; Tetanus; Diphtheria; Whooping Cough; Poliomyelitis

Interventions

Haemophilus influenzae type b-polysaccharide vaccine-diphtheria toxoid conjugate; Meningococcal Vaccines; Diphtheria-Tetanus-acellular Pertussis Vaccines

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases; Clostridium Infections; Gram-Positive Bacterial Infections; Corynebacterium Infections; Actinomycetales Infections; Bordetella Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Myelitis; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Spinal Cord Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Pertussis Vaccine; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Results Point of Contact

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

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2006
• First Posted: July 21, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 24, 2011
• Results First Posted: August 23, 2011

Record last verified: 2011-08

Locations

US (26)