Clinical trial NCT00444951: Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia
Official title: Evaluation of the Response to a Single Dose of Menactra® in Adolescents Aged 16 to 19 Years Who Previously Received One Dose of Quadrivalent (A, C, Y, W 135) and at Least One Dose of Bivalent (A, C) Meningococcal Polysaccharide Vaccine in Saudi Arabia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neisseria Meningitidis
Meningococcal Infections
Keywords: N meningitidis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-08
Enrollment: 450
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be conducted among adolescents in Saudi Arabia who previously received one dose of A, C, Y, W 135 and at least one dose of A, C meningococcal polysaccharide vaccine. This study will evaluate the booster administration of Menactra® (Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine) compared with Mencevax® (Meningococcal A, C, Y, and W 135 Polysaccharide vaccine)in terms of their serum bactericidal antibody responses.


Eligibility criteria: Inclusion Criteria:

* Healthy, as determined by medical history and physical examination.
* Aged between 16 to 19 years on the day of inclusion (from 16th birthday to 1 day before 20th birthday inclusive).
* For the Menactra® and Mencevax® groups, one dose of quadrivalent (A, C, Y, W 135) and at least one dose of bivalent (A, C) meningococcal polysaccharide vaccine with no meningococcal vaccine received less than 2 years prior to enrollment.
* For the Control group, no previous history of any meningococcal vaccination.
* Informed consent form signed by the parent(s) or other legal representative for subject under 18 years and signed by subject him/herself if subject above 18 years old
* 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 an 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 study 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 study vaccination, or scheduled to receive any vaccination during the 14-day period after study vaccination.
* Previous history of documented invasive meningococcal disease.
* 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.
* For female, known or suspected to be pregnant at the time of inclusion

Primary outcomes:
measure: Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
timeFrame: Baseline (Day 0) and Day 28 after vaccination
Secondary outcomes:
measure: Percentage of Participants With At Least a 4-Fold Rise in Titers Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Post-Menatcra® Vaccination
timeFrame: Baseline (Day 0) and Day 28 After Vaccination
measure: Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
timeFrame: Day 0 to Day 7 Post-vaccination
Other outcomes:
Locations:
city: Helal Ahmar
country: Saudi Arabia
state: Mecca
city: Iskan
country: Saudi Arabia
state: Mecca
city: AlKhaleej
country: Saudi Arabia
state: Qassim
city: AlRabwa
country: Saudi Arabia
state: Qassim
city: S. Buraida
country: Saudi Arabia
state: Qassim
city: Safra-Al Midhnab
country: Saudi Arabia
state: Qassim
city: Makkah
country: Saudi Arabia
Study officials:
affiliation: Sanofi Pasteur Inc
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Khalil M, Al-Mazrou Y, Findlow H, Chadha H, Bosch Castells V, Oster P, Borrow R. Meningococcal serogroup C serum and salivary antibody responses to meningococcal quadrivalent conjugate vaccine in Saudi Arabian adolescents previously vaccinated with bivalent and quadrivalent meningococcal polysaccharide vaccine. Vaccine. 2014 Sep 29;32(43):5715-21. doi: 10.1016/j.vaccine.2014.08.026. Epub 2014 Aug 20.