Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers

Study Overview
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Brief Summary
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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.

Official Title
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Safety Study of Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) When Administered With Other Pediatric Vaccines to Healthy Toddlers

Conditions
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Meningococcal Meningitis, Measles, Mumps, Rubella, Varicella

Intervention / Treatment
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* Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
* Biological: Measles-mumps-rubella-varicella vaccine
* Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV)
* Biological: Routine paediatric vaccine - Hepatitis A


Participation Criteria
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Eligibility Criteria
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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 bleeding disorder contraindicating intramuscular (IM) vaccination. Parent or legal guardian unable or unwilling to comply with the study procedures. Participation in another interventional clinical trial in the 30 days preceding enrollment, or participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period. Diagnosed with any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine. Received any vaccine in the 30-day period prior to receipt of the study vaccine(s), or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccine(s). Personal or family history of Guillain-Barré Syndrome (GBS). History of seizures, including febrile seizures, or any other neurologic disorder. Known hypersensitivity to dry natural rubber latex. For the subjects scheduled to provide blood samples: - Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to either of the study blood draws. Topical antibiotics and antibiotic drops are not included in this exclusion criterion.

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: Menactra® and Routine Pediatric Vaccines<br>Participants received Menactra® alone at age 9 months and Menactra® concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate [PCV], and hepatitis A [HepA]) at age 12 months. | Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate<br>* 0.5 mL, IM at age 9 and 12 months<br>* Other names: Menactra®;Biological: Measles-mumps-rubella-varicella vaccine<br>* 0.5 mL, intramuscular at 12 months of age<br>* Other names: MMRV: ProQuad;Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV)<br>* 0.5 mL, Intramuscular at age 12 months<br>* Other names: Pneumococcal conjugate (PCV),;Biological: Routine paediatric vaccine - Hepatitis A<br>* 0.5 mL, Intramuscular at age 12 months<br>* Other names: Hepatitis A;|
| Other: Group 2: Routine Pediatric Vaccines<br>Participants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months. | Biological: Measles-mumps-rubella-varicella vaccine<br>* 0.5 mL, intramuscular at 12 months of age<br>* Other names: MMRV: ProQuad;Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV)<br>* 0.5 mL, Intramuscular at age 12 months<br>* Other names: Pneumococcal conjugate (PCV),;Biological: Routine paediatric vaccine - Hepatitis A<br>* 0.5 mL, Intramuscular at age 12 months<br>* Other names: Hepatitis A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability | Day 0 to 7 Post-vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menactra® vaccine, Meningococcal meningitis, Measles, Mumps, Rubella, Varicella virus, Haemophilus influenzae type b, Pneumococcal conjugate vaccine