Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) in Older Adults in Turkey and Lebanon
- Conditions
- Healthy Volunteers (Meningococcal Infection)
- Interventions
- Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine
- Registration Number
- NCT03869866
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
The primary objectives of this study are:
* To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using baby rabbit complement (rSBA) before and after a single dose of MenACYW conjugate vaccine
* To describe the antibody response to meningococcal serogroups A, C, W, and Y measured by serum bactericidal assay using human complement (hSBA) before and after a single dose of MenACYW conjugate vaccine
* To describe the antibody responses against tetanus toxoid at baseline and after a single dose of MenACYW conjugate vaccine
* To describe the safety profile of a single dose of MenACYW conjugate vaccine
- Detailed Description
Study duration per participant is approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 290
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MenACYW conjugate vaccine Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine MenACYW conjugate single injection at Day 0
- Primary Outcome Measures
Name Time Method Percentage of Participants With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, W, and Y Day 30 post-dose Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the rSBA. Seroprotection rate is defined as percentage of participants with rSBA titer \>=1.8 who received MenACYW conjugate vaccine. Percentages are rounded off to the tenth decimal place.
Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA Day 30 post-dose Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the rSBA and the results were expressed as geometric mean titers.
Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Day 30 post-dose Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.
Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid Pre-dose Day 0 and Day 30 post-dose Tetanus toxoid was contained in the investigational vaccine as a carrier protein. Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate.
Percentage of Participants Who Achieved Seroprotective Levels Pre-dose Day 0 and Day 30 post-dose Seroprotective levels defined as antibody titers \>= 0.01 IU/mL and \>= 0.1 IU/mL of antibody concentrations to tetanus toxoid. Tetanus toxoid was contained in the investigational vaccine as a carrier protein. Anti-tetanus antibodies were measured by ECL assay. The captured antibodies were then detected using a sulfotag-conjugated anti-human IgG conjugate. Percentages are rounded off to the tenth decimal place.
Number of Participants With Unsolicited Systemic Adverse Events (AEs) Within 30 minutes post-dose An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions \[i.e.pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination\].
Number of Participants With Unsolicited Non-Serious Adverse Events Up to Day 30 post-dose An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e. pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination).
Number of Participants With Serious Adverse Events (SAEs) From Day 0 up to end of study, approximately 44 days A SAEs is defined as any untoward medical occurrence, at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other important medical event.
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions Up to 7 days post-dose All noxious and unintended responses to a study vaccine related to any dose was considered adverse reactions (AR). A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An injection site reaction is an AR at and around the injection site. Injection site reactions are commonly inflammatory reactions. They were considered to be related to the study vaccine administered. Systemic reactions were all ARs that were not injection or administration site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination or administration site.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Investigational Site Number : 4220001
🇱🇧Beirut, Lebanon
Investigational Site Number : 7920002
🇹🇷Ankara, Turkey
Investigational Site Number : 7920001
🇹🇷Ankara, Turkey