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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00483574
First received: June 6, 2007
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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 Intervention 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) and Hepatitis A
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

Enrollment: 1378
Study Start Date: May 2007
Study Completion Date: April 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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) and Hepatitis A
0.5 mL, Intramuscular at age 12 months
Other Names:
  • Pneumococcal conjugate (PCV),
  • Hepatitis A
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.
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) and Hepatitis A
0.5 mL, Intramuscular at age 12 months
Other Names:
  • Pneumococcal conjugate (PCV),
  • Hepatitis A

  Eligibility

Ages Eligible for Study:   9 Months to 12 Months
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00483574

  Show 80 Study Locations
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00483574     History of Changes
Other Study ID Numbers: MTA48
Study First Received: June 6, 2007
Results First Received: May 10, 2011
Last Updated: January 20, 2014
Health Authority: United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile

Keywords provided by Sanofi:
Menactra® vaccine
Meningococcal meningitis
Measles
Mumps
Rubella
Varicella virus
Haemophilus influenzae type b
Pneumococcal conjugate vaccine

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Rubella
Bacterial Infections
Central Nervous System Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Meningitis, Bacterial
Meningococcal Infections
Neisseriaceae Infections
Nervous System Diseases
RNA Virus Infections
Rubivirus Infections
Togaviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014