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

Immunogenicity and Safety of Meningococcal (Serogroups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Children Aged 4 to 6 Years in the US When Administered Concomitantly With a Fifth Dose Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed.

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.

Study Overview

• Status: Completed
• Conditions: Pertussis; Tetanus; Diphtheria; Poliomyelitis; Meningococcal Meningitis
• Intervention / Treatment: Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine

• Study Type: Interventional
• Enrollment (Actual): 882
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
  • Colorado
    • Boulder, Colorado, United States, 80304
  • Georgia
    • Atlanta, Georgia, United States, 30322
    • Layton, UT 84041, Georgia, United States, 30062
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
  • Massachusetts
    • Woburn, Massachusetts, United States, 01801
  • Missouri
    • Bridgeton, Missouri, United States, 63044
    • St. Louis, Missouri, United States, 63141
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
  • New York
    • Rochester, New York, United States, 14620
    • Syracuse, New York, United States, 13210
  • Ohio
    • Akron, Ohio, United States, 44308
    • Cincinnati, Ohio, United States, 45229
    • Columbus, Ohio, United States, 43205
    • University Heights, Ohio, United States, 44118
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
    • Sellersville, Pennsylvania, United States, 18960
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
  • Utah
    • Layton, Utah, United States, 84041
    • Ogden, Utah, United States, 84405
    • Pleasant Grove, Utah, United States, 84062
    • Provo, Utah, United States, 84604
    • Salt Lake City, Utah, United States, 84123
    • South Jordan, Utah, United States, 84095
  • Virginia
    • Norfolk, Virginia, United States, 23510
  • Washington
    • Spokane, Washington, United States, 99220

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; DAPTACEL® + IPOL on Day 0 and Menactra on Day 30	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30); Other Names: Menactra®; DAPTACEL®; IPOL; Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30); Other Names: Menactra®; DAPTACEL®; IPOL; Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30); Other Names: Menactra®; DAPTACEL®; IPOL
Experimental: Group 2; DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30); Other Names: Menactra®; DAPTACEL®; IPOL; Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30); Other Names: Menactra®; DAPTACEL®; IPOL; Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30); Other Names: Menactra®; DAPTACEL®; IPOL
Experimental: Group 3; Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30); Other Names: Menactra®; DAPTACEL®; IPOL; Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30); Other Names: Menactra®; DAPTACEL®; IPOL; Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine; 0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30); Other Names: Menactra®; DAPTACEL®; IPOL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1	Serum antibody titers against pertussis were assessed for pertussis toxoid (PT), filamentous hemagglutinin (FHA), Fimbriae types 2 and 3 (FIM), and pertactin (RN) by enzyme linked immunosorbent assay (ELISA).	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	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
Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine	Fever was defined as a maximum oral temperature of ≥ 100.4ºF.	Day 0 through Day 7 post-vaccination at Visit 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric Mean Titers Against Poliovirus After IPOL Vaccination.	Serum antibodies were assessed for poliovirus types 1, 2, and 3 by serum neutralization assay.	Day 30 post-vaccination
Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1	Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.	Day 0 through Day 7 post-vaccination
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2	Solicited Injection Site Reactions: Pain, Erythema, and Redness. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, and Myalgia.	Day 0 through Day 7 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 1, 2006
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 20, 2006
• First Submitted That Met QC Criteria: July 20, 2006
• First Posted (Estimate): July 21, 2006

Study Record Updates

• Last Update Posted (Estimate): August 24, 2011
• Last Update Submitted That Met QC Criteria: August 22, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Meningococcal meningitis; Pertussis; Diphtheria; Tetanus; Poliomyelitis; Neisseria meningitidis
• Additional Relevant MeSH Terms: Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neurologic Manifestations; Neuromuscular Diseases; Central Nervous System Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Actinomycetales Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Corynebacterium Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Neisseriaceae Infections; Myelitis; Whooping Cough; Tetanus; Diphtheria; Tetany; Meningitis, Meningococcal; Meningitis; Poliomyelitis; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: MTA43