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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00355121

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: Polysaccharide Diphtheria Toxoid Conjugate Vaccine	Phase II

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

Drug Information available for: Meningococcal Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

To provide information concerning the immune response of DAPTACEL®. [ Time Frame: 30 Days post-vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To provide information concerning the safety after concomitant administration of DAPTACEL® and Menactra® vaccines. [ Time Frame: 30 Days post-vaccination ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1024
Study Start Date:	October 2006
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL IM of each vaccine. (DAPTACEL® + IPOL on Day 0 and Menactra on Day 30)
2: Experimental	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL, IM of each vaccine. (DAPTACEL® + Menactra® on Day 0 and IPOL on Day 30)
3: Experimental	Biological: Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL, IM of each vaccine (Menactra® + IPOL on Day 0 and DAPTACEL® on Day 30)

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

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi Pasteur Inc ( Medical Director )
Study ID Numbers:	MTA43
Study First Received:	July 20, 2006
Last Updated:	June 27, 2008
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
Gram-Positive Bacterial Infections
Respiratory Tract Diseases
Respiratory Tract Infections
Neuromuscular Diseases
Meningococcal Infections
Motor Neuron Disease

Neisseriaceae Infections
Meningitis, Bacterial
Cough
Central Nervous System Diseases
Picornaviridae Infections
Degenerative motor system disease
Diphtheria
Motor neuron disease
Meningococcal infection
Virus Diseases
Central Nervous System Infections
Poliomyelitis
Myelitis
Enterovirus Infections
Clostridium Infections

Additional relevant MeSH terms:

Bordetella Infections
RNA Virus Infections
Corynebacterium Infections
Nervous System Diseases

Central Nervous System Bacterial Infections
Central Nervous System Viral Diseases
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on January 14, 2009