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

Meningococcal Infections Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00444951
• Other study ID #: MTA40
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2007
• Last updated: June 16, 2015
• Start date: February 2007
• Est. completion date: February 2009

Study information

• Verified date: June 2015
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: February 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Infections
• Neisseria Meningitidis

Intervention

Biological:
• Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine
0.5 mL, Intramuscular
• Mencevax®: Group A, C, W135 and Y polysaccharide meningococcal vaccine
0.5 mL, Subcutaneous
• Menactra®: Meningococcal A, C, Y, and W 135 Polysaccharide Diphtheria Toxoid Conjugate vaccine
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, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Post-vaccination		Day 0 to Day 7 Post-vaccination	No

External Links

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