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Immunology and Safety of Menactra® in Children in Saudi Arabia

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ClinicalTrials.gov Identifier: NCT00539032
Recruitment Status : Completed
First Posted : October 3, 2007
Results First Posted : January 24, 2011
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE October 2, 2007
First Posted Date  ICMJE October 3, 2007
Results First Submitted Date  ICMJE September 9, 2009
Results First Posted Date  ICMJE January 24, 2011
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE September 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2010)
  • Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination. [ Time Frame: Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination ]
  • Percentage of Participants With ≥ 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135. [ Time Frame: Day 28 Post-vaccination ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00539032 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)
Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® [ Time Frame: Days 0-7 Post-vaccination ]
Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunology and Safety of Menactra® in Children in Saudi Arabia
Official Title  ICMJE Evaluation of the Response to a Single Dose of Menactra® in Children Aged 5 to 8 Years Who Had Previously Received Two Doses of Quadrivalent (A, C, Y, W-135) Meningococcal Polysaccharide Vaccine Before Age 2 Years in Saudi Arabia
Brief Summary This study will be conducted among children in Saudi Arabia who previously received two doses of A, C, Y, W-135 polysaccharide vaccine before the age of 2 years, and in meningococcal vaccine-naïve children (Control Group). This study will evaluate the administration of Menactra® in terms of the serum bactericidal antibody it induces in the two study groups. Safety of Menactra® vaccine will be described.
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
  • Meningitis
  • Meningococcemia
Intervention  ICMJE Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra® Vaccine
Study Arms  ICMJE
  • Experimental: Group 1: Menactra® Booster Group
    Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
    Intervention: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
  • Experimental: Group 2: Menactra® Primary Vaccine (Control) Group
    Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
    Intervention: Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Publications * Khalil M, Al-Mazrou Y, Findlow H, Chadha H, Bosch Castells V, Johnson DR, Borrow R. Safety and immunogenicity of a meningococcal quadrivalent conjugate vaccine in five- to eight-year-old Saudi Arabian children previously vaccinated with two doses of a meningococcal quadrivalent polysaccharide vaccine. Clin Vaccine Immunol. 2012 Oct;19(10):1561-6. Epub 2012 Aug 1.

*   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: July 15, 2009)
238
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2007)
225
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria :

  • Healthy, as determined by medical history and physical examination.
  • Aged between 5 to 8 years on the day of inclusion (from 5th birthday to 1 day before 9th birthday inclusive).
  • For the Booster Group , two doses of a quadrivalent (A, C, Y, W-135) meningococcal polysaccharide vaccine received before age 2 years
  • For the Control Group , no previous history of any meningococcal vaccination
  • Informed consent form signed by the parent(s) or other legal representative
  • Able to provide a vaccination log or has available vaccination record in the Health Center.
  • Able to attend all scheduled visits and to comply with all trial procedures

Exclusion Criteria :

  • Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.)
  • Known or suspected impairment of immunologic function.
  • Acute medical illness with or without fever within the last 72 hours or a oral temperature ≥ 37.5°C at the time of inclusion.
  • Administration of immune globulin or other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the trial vaccine. Individuals on a tapering dose schedule of oral steroids lasting < 7 days may be included in the trial provided that they have not received more than one course within the last two weeks prior to enrollment.
  • Oral or injected antibiotic therapy within the 72 hours prior to vaccination.
  • Received any vaccine in the 14-day period prior to trial vaccination, or scheduled to receive any vaccination during the 14-day period after trial vaccination.
  • Previous history of documented invasive meningococcal disease.
  • For the Control Group, previous history of any meningococcal vaccination.
  • Systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances.
  • Participation in another clinical trial in the 4 weeks preceding the trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • 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.
  • Personal or family history of Guillain Barré syndrome.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00539032
Other Study ID Numbers  ICMJE MTA47
Has Data Monitoring Committee Not Provided
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