Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia
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.
1 other identifier
interventional
450
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2007
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 7, 2007
CompletedFirst Posted
Study publicly available on registry
March 8, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedResults Posted
Study results publicly available
March 4, 2011
CompletedJuly 14, 2015
June 1, 2015
1 year
March 7, 2007
February 9, 2011
June 16, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination
Baseline (Day 0) and Day 28 after vaccination
Secondary Outcomes (2)
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
Baseline (Day 0) and Day 28 After Vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination
Day 0 to Day 7 Post-vaccination
Study Arms (3)
Menactra® group
EXPERIMENTALHave received previously a dose of an A, C, Y, W 135 and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, will receive a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.
Mencevax® group
EXPERIMENTALHave received previously a dose of an A, C, Y, W 135 and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, will receive a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
Control group
EXPERIMENTALParticipants have not previously received any meningococcal vaccine, will receive a booster dose of Menactra® (Meningococcal \[serogroups A, C, Y, W-135\] polysaccharide diphtheria toxoid conjugate) vaccine.
Interventions
0.5 mL, Intramuscular
0.5 mL, Subcutaneous
Eligibility Criteria
You may qualify if:
- Healthy, as determined by medical history and physical examination.
- 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
You may not qualify if:
- Serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.)
- Known or suspected impairment of immunologic function.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
AlKhaleej, Al-Qassim Region, Saudi Arabia
Unknown Facility
AlRabwa, Al-Qassim Region, Saudi Arabia
Unknown Facility
S. Buraida, Al-Qassim Region, Saudi Arabia
Unknown Facility
Safra-Al Midhnab, Al-Qassim Region, Saudi Arabia
Unknown Facility
Helal Ahmar, Mecca Region, Saudi Arabia
Unknown Facility
Iskan, Mecca Region, Saudi Arabia
Unknown Facility
Mecca, Mecca Region, Saudi Arabia
Related Publications (1)
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.
PMID: 25151042BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Sanofi Pasteur Inc.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Sanofi Pasteur Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2007
First Posted
March 8, 2007
Study Start
February 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2009
Last Updated
July 14, 2015
Results First Posted
March 4, 2011
Record last verified: 2015-06