Trial record 1 of 1 for:
MTA48
Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
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| ClinicalTrials.gov Identifier: NCT00483574 |
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Recruitment Status :
Completed
First Posted : June 7, 2007
Results First Posted : July 6, 2011
Last Update Posted : May 16, 2016
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Sponsor:
Sanofi Pasteur, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Meningococcal Meningitis Measles Mumps Rubella Varicella | 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 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1378 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Prevention |
| Official Title: | 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 |
| Study Start Date : | May 2007 |
| Actual Primary Completion Date : | January 2009 |
| Actual Study Completion Date : | April 2009 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Shingles
MedlinePlus related topics:
Vaccines
| Arm | Intervention/treatment |
|---|---|
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Experimental: Group 1: Menactra® and Routine Pediatric Vaccines
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.
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Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, IM at age 9 and 12 months
Other Name: Menactra® Biological: Measles-mumps-rubella-varicella vaccine 0.5 mL, intramuscular at 12 months of age
Other Name: MMRV: ProQuad Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV) 0.5 mL, Intramuscular at age 12 months
Other Name: Pneumococcal conjugate (PCV), Biological: Routine paediatric vaccine - Hepatitis A 0.5 mL, Intramuscular at age 12 months
Other Name: Hepatitis A |
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Group 2: Routine Pediatric Vaccines
Participants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months.
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Biological: Measles-mumps-rubella-varicella vaccine
0.5 mL, intramuscular at 12 months of age
Other Name: MMRV: ProQuad Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV) 0.5 mL, Intramuscular at age 12 months
Other Name: Pneumococcal conjugate (PCV), Biological: Routine paediatric vaccine - Hepatitis A 0.5 mL, Intramuscular at age 12 months
Other Name: Hepatitis A |
Primary Outcome Measures :
- Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. [ Time Frame: Day 0 to 7 Post-vaccination ]
Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling.
Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability
Other Outcome Measures:
- Safety Overview After Any Vaccination in Participants Who Received MMR+V [ Time Frame: Day 0 to 7 Post-vaccination ]
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| Ages Eligible for Study: | 9 Months to 12 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00483574
Locations
Show 80 study locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
| Study Director: | Medical Director | Sanofi Pasteur Inc |
Additional Information:
| Responsible Party: | Sanofi Pasteur, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT00483574 |
| Other Study ID Numbers: |
MTA48 |
| First Posted: | June 7, 2007 Key Record Dates |
| Results First Posted: | July 6, 2011 |
| Last Update Posted: | May 16, 2016 |
| Last Verified: | April 2016 |
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
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Menactra® vaccine Meningococcal meningitis Measles Mumps |
Rubella Varicella virus Haemophilus influenzae type b Pneumococcal conjugate vaccine |
Additional relevant MeSH terms:
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Measles Chickenpox Herpes Zoster Rubella Meningitis, Meningococcal Meningitis Central Nervous System Diseases Nervous System Diseases Morbillivirus Infections Paramyxoviridae Infections Mononegavirales Infections RNA Virus Infections Virus Diseases Infections Varicella Zoster Virus Infection |
Herpesviridae Infections DNA Virus Infections Rubivirus Infections Togaviridae Infections Meningitis, Bacterial Central Nervous System Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections Central Nervous System Infections Vaccines Immunologic Factors Physiological Effects of Drugs |