Immunogenicity and Safety of Menactra® Vaccine in Adolescents in Saudi Arabia

• ClinicalTrials.gov Identifier: NCT00444951
• Recruitment Status: Completed
• First Posted: March 8, 2007
• Results First Posted: March 4, 2011
• Last Update Posted: July 14, 2015
• Sponsor: Sanofi Pasteur, a Sanofi Company
• Information provided by (Responsible Party): Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Neisseria Meningitidis; Meningococcal Infections	Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine; Biological: Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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 Start Date: February 2007
• Actual Primary Completion Date: February 2008
• Actual Study Completion Date: February 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Menactra® group; Have 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.	Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine; 0.5 mL, Intramuscular; Other Name: Menactra®
Experimental: Mencevax® group; Have 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.	Biological: Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine; 0.5 mL, Subcutaneous; Other Name: Mencevax®
Experimental: Control group; Participants 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.	Biological: Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine; 0.5 mL, Intramuscular; Other Name: Menactra®

Outcome Measures

Primary Outcome Measures :

1. Geometric Mean Titers (GMTs) of Vaccine Serogroups Determined by Serum Bactericidal Activity Using Baby Rabbit Complement (SBA-BR) Pre- and Post-Menactra® Vaccination [ Time Frame: Baseline (Day 0) and Day 28 after vaccination ]

Secondary Outcome Measures :

1. 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 [ Time Frame: Baseline (Day 0) and Day 28 After Vaccination ]
2. Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination [ Time Frame: Day 0 to Day 7 Post-vaccination ]

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 19 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Saudi Arabia

Helal Ahmar, Mecca, Saudi Arabia

Iskan, Mecca, Saudi Arabia

AlKhaleej, Qassim, Saudi Arabia

AlRabwa, Qassim, Saudi Arabia

S. Buraida, Qassim, Saudi Arabia

Safra-Al Midhnab, Qassim, Saudi Arabia

Makkah, Saudi Arabia

Sponsors and Collaborators

Sanofi Pasteur, a Sanofi Company

Investigators

• Study Director: Medical Monitor; Sanofi Pasteur Inc

More Information

Additional Information:

Related Info 

Publications:

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.

• Responsible Party: Sanofi Pasteur, a Sanofi Company
• ClinicalTrials.gov Identifier: NCT00444951
• Other Study ID Numbers: MTA40
• First Posted: March 8, 2007
• Results First Posted: March 4, 2011
• Last Update Posted: July 14, 2015
• Last Verified: June 2015

Keywords provided by Sanofi ( Sanofi Pasteur, a Sanofi Company ):

N meningitidis

Additional relevant MeSH terms:

Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs