The MEQ00074 study was a Phase III, open-label, single-center study aimed at describing the immunogenicity and safety of a single dose of investigational quadrivalent Meningococcal Polysaccharide (serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine (MenACYW conjugate vaccine) in participants aged 12 months and older in Vietnam. The primary objectives of the study were: * To describe the antibody responses to meningococcal serogroups A, C, W, and Y before and 30 days after the administration of a single dose of MenACYW conjugate vaccine * To describe the safety profile of a single dose of MenACYW conjugate vaccine The duration of each participant's participation will be approximately 30 to 44 days.
The duration of each participant's participation was approximately 30 to 44 days.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
447
Pharmaceutical form:Liquid solution-Route of administration:Intramuscular injection
Investigational Site Number : 7040001
Hanoi, Vietnam
Investigational Site Number : 7040002
Thái Bình, Vietnam
Investigational Site Number : 7040003
Thái Bình, Vietnam
Investigational Site Number : 7040004
Thái Bình, Vietnam
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured in a serum bactericidal assay utilizing the human complement (hSBA).
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=4-Fold Rise From Pre-Vaccination to Post-Vaccination
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured by hSBA. Percentages are rounded off to the tenth decimal place.
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured by hSBA. Percentages are rounded off to the tenth decimal place.
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Percentage of Participants With Serum Bactericidal Assay Using Human Complement Vaccine Seroresponse for Serogroups A, C, Y, and W
Functional meningococcal antibody activity against serogroups A, C, Y, and W was measured by hSBA. hSBA vaccine seroresponse was defined as follows: for a participant with a pre-vaccination titer \<1:8, the post-vaccination titer must be \>=1:16, and for a participant with a pre-vaccination titer \>=1:8, the post-vaccination titer must be at least 4-fold greater than the pre-vaccination titer. Percentages are rounded off to the tenth decimal place.
Time frame: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)
Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the case report form (CRF) in terms of diagnosis and onset window post-vaccination. Immediate events were recorded to capture medically relevant unsolicited systemic AEs (including those related to the study vaccine administered) which occurred within the first 30 minutes after vaccination.
Time frame: Up to 30 minutes post-vaccination on Day 1
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions
A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRF. An injection site reaction was an AR at and around the injection site considered to be related to the study vaccine administered and were commonly inflammatory reactions. Systemic ARs were all ARs that were not injection site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations.
Time frame: From the study vaccine administration (Day 1) up to 7 days post-vaccination, up to Day 8
Number of Participants With Unsolicited Non-Serious Adverse Events
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE was an observed AE that did not fulfill the conditions of solicited reactions, i.e., pre-listed in the CRF in terms of diagnosis and onset window post-vaccination.
Time frame: From the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An SAE was any AE that, at any dose, resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was other medically important event. An AESI (serious or non-serious) was one of scientific and medical concern specific to the Sponsor's study vaccine or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor was appropriate.
Time frame: From the study vaccine administration (Day 1) up to 30 days post-vaccination (Day 31)
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