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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00483574
Recruitment Status : Completed
First Posted : June 7, 2007
Results First Posted : July 6, 2011
Last Update Posted : May 16, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE June 6, 2007
First Posted Date  ICMJE June 7, 2007
Results First Submitted Date  ICMJE May 10, 2011
Results First Posted Date  ICMJE July 6, 2011
Last Update Posted Date May 16, 2016
Study Start Date  ICMJE May 2007
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2011)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00483574 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: January 20, 2014)
Safety Overview After Any Vaccination in Participants Who Received MMR+V [ Time Frame: Day 0 to 7 Post-vaccination ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety of Menactra® Vaccine When Administered With Other Pediatric Vaccines to Healthy Toddlers
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Meningococcal Meningitis
  • Measles
  • Mumps
  • Rubella
  • Varicella
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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
  • 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.
    Interventions:
    • Biological: Measles-mumps-rubella-varicella vaccine
    • Biological: Routine paediatric vaccine - Pneumococcal conjugate (PCV)
    • Biological: Routine paediatric vaccine - Hepatitis A
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 30, 2009)
1378
Original Estimated Enrollment  ICMJE
 (submitted: June 6, 2007)
1820
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Months to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00483574
Other Study ID Numbers  ICMJE MTA48
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP