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Trial record 1 of 1 for:    MTA47
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Immunology and Safety of Menactra® in Children in Saudi Arabia

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

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.

Condition or disease Intervention/treatment Phase
Meningitis Meningococcemia Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 238 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Meningitis Vaccines

Arm Intervention/treatment
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.
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra® Vaccine

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.
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
Other Name: Menactra® Vaccine

Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Other Outcome Measures:
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

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 identifier (NCT number): NCT00539032

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Saudi Arabia
AlKhaleej, Qassim, Saudi Arabia
AlRabwa, Qassim, Saudi Arabia
S. Buraida, Qassim, Saudi Arabia
Safra-Al Midhnab, Qassim, Saudi Arabia
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
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Study Director: Medical Director Sanofi Pasteur Inc.
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanofi Pasteur, a Sanofi Company Identifier: NCT00539032    
Other Study ID Numbers: MTA47
First Posted: October 3, 2007    Key Record Dates
Results First Posted: January 24, 2011
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):
N. meningitidis
Additional relevant MeSH terms:
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Central Nervous System Diseases
Nervous System Diseases
Immunologic Factors
Physiological Effects of Drugs