Immunology and Safety of Menactra® in Children in Saudi Arabia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00539032
First received: October 2, 2007
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Meningitis
Meningococcemia
Biological: Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra® [ Time Frame: Days 0-7 Post-vaccination ] [ Designated as safety issue: No ]
    Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia.


Enrollment: 238
Study Start Date: September 2007
Study Completion Date: February 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00539032

Locations
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
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00539032     History of Changes
Other Study ID Numbers: MTA47
Study First Received: October 2, 2007
Results First Received: September 9, 2009
Last Updated: January 20, 2014
Health Authority: Saudi Arabia: Ministry of Health

Keywords provided by Sanofi:
N. meningitidis
Meningitis
Meningococcemia

Additional relevant MeSH terms:
Meningitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 16, 2014