Subjects Adults = 56 years of age intending to go on a Hajj or Umrah pilgrimage (but not within the next 10 to 12 months after vaccination) will be enrolled in the study to receive a single dose of MenACYW conjugate vaccine. Meningitis prophylaxis
Conditions
Interventions
- Vaccination: Investigational Product: MenACYW conjugate vaccine
All subjects will receive a single dose of MenACYW conjugate vaccine at Visit 1 (D0).
Meningococcal Polysaccharide (Serogroups A, C, Y
at V1
at V1-V2
vaccination
Blood sample drawing
Sponsors
Sanofi Pasteur
Sanofi Pasteur-Liban
Eligibility
Sex/Gender
All
Age
56 Years to 90 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: An individual must fulfill all of the following criteria in order to be eligible for trial enrollment: 1) Aged = 56 years on the day of inclusion 2) Informed consent form has been signed and dated 3) Able to attend all scheduled visits and to comply with all trial procedures 4) Intending to go on a Hajj or Umrah pilgrimage (but not within the next 10 to 12 months after vaccination)
Exclusion criteria
Exclusion criteria: Exclusion criteria: An individual fulfilling any of the following criteria is to be excluded from trial enrollment: 1) Subject is pregnant, or lactating, or of childbearing potential 2) Participation in another clinical trial 3) Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination 4) Any previous vaccination against meningococcal disease with either the trial vaccine or another vaccine 5) Receipt of immune globulins, blood or blood-derived products in the past 3 months 6) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy 7) History of meningococcal infection 8) At high risk for meningococcal infection during the trial 9) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines 10) Personal history of Guillain-Barre syndrome (GBS) 11) Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine 12) Verbal report thrombocytopenia 13) Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion 14) Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily 15) Current alcohol abuse or drug addiction 16) Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion 17) Moderate or severe acute illness/infection on the day of vaccination or febrile illness (temperature = 38.0°C). 18) Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw 19) Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member of the Investigator or employee with direct involvement in the proposed study (Protocol page 14, 15)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Name: Immunogenicity;Timepoints: at 30 days (+14 days) after vaccination;Measure: Antibody titers = 1:8 against meningococcal serogroups A, C, W, and Y;Name: Safety;Timepoints: reported in the 30 minutes after vaccination.;Measure: any unsolicited systemic AEs ;Name: Safety;Timepoints: occurring up to 7 days after vaccination;Measure: injection site reactions;Name: Safety;Timepoints: occurring up to 7 days after vaccination.;Measure: systemic reactions ;Name: Safety;Timepoints: occurring up to Visit 2.;Measure: unsolicited non-serious AEs ;Name: Safety;Timepoints: throughout the trial;Measure: SAEs (including AESIs) | — |
Secondary
| Measure | Time frame |
|---|---|
| Name: NA;Timepoints: NA;Measure: NA | — |
Countries
Lebanon, Turkey
Contacts
Public ContactGhassan Dbaibo
American university of Beirut
Outcome results
None listed