Tetanus Clinical Trial
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.
Verified date | August 2011 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 882 |
Est. completion date | July 2009 |
Est. primary completion date | June 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 7 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 |
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