Immunology and Safety of Menactra® in Children in Saudi Arabia

Meningitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00539032
• Other study ID #: MTA47
• Status: Completed
• Phase: Phase 3
• First received: October 2, 2007
• Last updated: April 12, 2016
• Start date: September 2007
• Est. completion date: February 2009

Study information

• Verified date: April 2016
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: February 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 8 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Meningococcemia

Intervention

Biological:
• Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular
• Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Reporting At Least 1 Solicited Injection Site or Systemic Reaction Post-Vaccination With Menactra®	Solicited injection Site reactions: Pain, erythema, and swelling; Solicited systemic reactions: Fever, headache, malaise and myalgia.	Days 0-7 Post-vaccination	No
Primary	Geometric Mean Titers (GMTs) as Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination.		Day 0 (baseline or pre-vaccination) and Day 28 Post-vaccination	No
Primary	Percentage of Participants With = 4-Fold Rise in Titers for the Menactra® Vaccine Serogroups A, C, Y, and W-135.		Day 28 Post-vaccination	No

External Links

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