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

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ClinicalTrials.gov Identifier: NCT00355121
Recruitment Status : Completed
First Posted : July 21, 2006
Results First Posted : August 23, 2011
Last Update Posted : August 24, 2011
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE July 20, 2006
First Posted Date  ICMJE July 21, 2006
Results First Submitted Date  ICMJE July 25, 2011
Results First Posted Date  ICMJE August 23, 2011
Last Update Posted Date August 24, 2011
Study Start Date  ICMJE October 2006
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2011)
  • Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination [ Time Frame: Day 30 post-vaccination (Visit 1) ]
    Serum antibody titers were assessed for diphtheria by a seroneutralization assay and for tetanus by enzyme linked immunosorbent assay.
  • Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1. [ Time Frame: Day 30 post-vaccination (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)
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00355121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2011)
  • Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1 [ Time Frame: Day 30 post-vaccination 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).
  • Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination [ Time Frame: Day 30 post-vaccination ]
    Serum antibody titers against meningococcal serogroups A, C, Y, and W-135 were assessed by serum bactericidal assay using human complement (SBA HC)
  • Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine [ Time Frame: Day 0 through Day 7 post-vaccination at Visit 1 ]
    Fever was defined as a maximum oral temperature of ≥ 100.4ºF.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningococcal Meningitis
  • Tetanus
  • Diphtheria
  • Pertussis
  • Poliomyelitis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Group 1
    DAPTACEL® + IPOL on Day 0 and Menactra on Day 30
    Intervention: Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
  • Experimental: Group 2
    DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30
    Intervention: Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
  • Experimental: Group 3
    Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30
    Intervention: Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 22, 2010)
882
Original Enrollment  ICMJE
 (submitted: July 20, 2006)
1024
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00355121
Other Study ID Numbers  ICMJE MTA43
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP