Purpose

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.


Condition Intervention Phase
Meningococcal Meningitis
Tetanus
Diphtheria
Pertussis
Poliomyelitis
Biological: Menactra®: Polysaccharide Diphtheria Conjugate Vaccine
Phase II

Genetics Home Reference related topics:   Neurologic Diseases  

MedlinePlus related topics:   Diphtheria   Meningitis   Polio and Post-Polio Syndrome   Tetanus   Whooping Cough  

ChemIDplus related topics:   Meningococcal Vaccines  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Estimated Enrollment:   1024
Study Start Date:   October 2006

  Eligibility
Ages Eligible for Study:   4 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355121

 Show 26 Study Locations

Sponsors and Collaborators
Sanofi-Aventis

Investigators
Study Director:     Clinical Trials     sanofi pasteur    
Sanofi-Aventis
Study Director:     Clinical Trials     sanofi pasteur    
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 
Related Info  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   MTA43
First Received:   July 20, 2006
Last Updated:   June 25, 2007
ClinicalTrials.gov Identifier:   NCT00355121
Health Authority:   United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:
Meningococcal meningitis  
Tetanus  
Diphtheria  
Pertussis
Poliomyelitis
Neisseria meningitidis

Study placed in the following topic categories:
Bacterial Infections
Spinal Cord Diseases
Meningitis, Meningococcal
Whooping Cough
Neisseria meningitidis
Tetanus
Whooping cough
Gram-Negative Bacterial Infections
Meningitis
Mycoses
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Neuromuscular Diseases
Meningococcal Infections
Motor Neuron Disease
Neisseriaceae Infections
Meningitis, Bacterial
Cough
Central Nervous System Diseases
Picornaviridae Infections

Additional relevant MeSH terms:
Clostridium Infections
Virus Diseases
Bordetella Infections
RNA Virus Infections
Respiratory Tract Diseases
Corynebacterium Infections
Bacterial Infections and Mycoses
Nervous System Diseases
Central Nervous System Bacterial Infections
Central Nervous System Viral Diseases
Infection
Actinomycetales Infections

Source: National Library of Medicine (NLM) June 26, 2008