Clinical trial NCT00355121: Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Meningitis
Tetanus
Diphtheria
Pertussis
Poliomyelitis
Keywords: Meningococcal meningitis
Tetanus
Diphtheria
Pertussis
Poliomyelitis
Neisseria meningitidis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-07-21
Enrollment: 882
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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).

Primary outcomes:
measure: Number of Participants With Antibodies Against Diphtheria and Tetanus at ≥ 1.0 IU/mL After DAPTACEL Vaccination
timeFrame: Day 30 post-vaccination (Visit 1)
measure: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W-135 After Menactra Vaccination at Visit 1.
timeFrame: Day 30 post-vaccination (Visit 1)
Secondary outcomes:
measure: Geometric Mean Concentrations (GMCs) of Antibodies Against the Pertussis Antigens After DAPTACEL Vaccination at Visit 1
timeFrame: Day 30 post-vaccination 1
measure: Serum Bactericidal Assay Using Human Complement Geometric Mean Titers for Serogroups A, C, Y, and W-135 After Menactra Vaccination
timeFrame: Day 30 post-vaccination
measure: Number of Participants Reporting Fever When DAPTACEL and Menactra Vaccines Were Administered Concomitantly and Those Reporting When DAPTACEL Was Administered With IPOL Vaccine
timeFrame: Day 0 through Day 7 post-vaccination at Visit 1
Other outcomes:
measure: Geometric Mean Titers Against Poliovirus After IPOL Vaccination.
timeFrame: Day 30 post-vaccination
measure: Number of Participants Reporting Solicited Injection Site and Systemic Reactions After Vaccinations at Visit 1
timeFrame: Day 0 through Day 7 post-vaccination
measure: Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination at Visit 2
timeFrame: Day 0 through Day 7 post-vaccination
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Boulder
country: United States
state: Colorado
city: Atlanta
country: United States
state: Georgia
city: Layton, UT 84041
country: United States
state: Georgia
city: Bardstown
country: United States
state: Kentucky
city: Woburn
country: United States
state: Massachusetts
city: Bridgeton
country: United States
state: Missouri
city: St. Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Rochester
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: University Heights
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Sellersville
country: United States
state: Pennsylvania
city: Kingsport
country: United States
state: Tennessee
city: Layton
country: United States
state: Utah
city: Ogden
country: United States
state: Utah
city: Pleasant Grove
country: United States
state: Utah
city: Provo
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: