Immunology and Safety of Menactra® in Children in Saudi Arabia

NCT ID: NCT00539032

Last Updated: 2016-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-02-28

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.

Conditions

Meningitis; Meningococcemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

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.

Group Type: EXPERIMENTAL

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Menactra® Vaccine; Menactra® Vaccine

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

AlKhaleej, Al-Qassim Region, Saudi Arabia

AlRabwa, Al-Qassim Region, Saudi Arabia

S. Buraida, Al-Qassim Region, Saudi Arabia

Safra-Al Midhnab, Al-Qassim Region, Saudi Arabia

Countries

Saudi Arabia

References

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. doi: 10.1128/CVI.00260-12. Epub 2012 Aug 1.

Reference Type: DERIVED

PMID: 22855388 (View on PubMed)

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

MTA47

Identifier Type: -

Identifier Source: org_study_id