Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healt… (NCT00483574) | Clinical Trial Compass
CompletedPhase 3
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
United States1,378 participantsStarted 2007-05
Plain-language summary
This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US.
Safety Objective:
To describe the safety profile of two doses of Menactra® Vaccine.
Who can participate
Age range9 Months – 12 Months
SexALL
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Inclusion Criteria :
* Healthy, as determined by medical history and physical examination
* Aged 9 months (249 to 305 days) or 12 months (365 to 400 days) at the time of enrollment
* The parent or legal guardian has signed and dated the Independent Ethics Committee (IEC)-/Institutional Review Board (IRB)-approved informed consent form.
Exclusion Criteria :
* Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion.
* Known or suspected impairment of immunologic function.
* Acute medical illness within the last 72 hours or a temperature ≥ 100.4ºF (≥ 38.0ºC) at the time of enrollment.
* History of documented invasive meningococcal disease or previous meningococcal vaccination.
* Has received the fourth dose of Prevnar, or the first dose of measles-mumps-rubella (MMR), varicella, or hepatitis A (HepA) vaccine.
* Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian.
* Received either immune globulin or other blood products within the last 3 months.
* Suspected or known hypersensitivity to any of the vaccine components.
* Thrombocytopenia or a blee…
What they're measuring
1
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.