Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Potential Pilgrims Aged 56 Years and Older

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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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.