Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine)
BiologicalPharmaceutical form: Liquid solution Route of administration: IM
NCT Number: NCT04368429
Primary Objective:
To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) compared with those observed following the administration of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine).
Secondary Objective:
Immunogenicity: To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) after vaccination with MenACYW Conjugate vaccine or Menactra®.
Safety: To describe the safety profile of MenACYW Conjugate vaccine and that of Menactra®.
Looking for future studies?
Notify Me2 year–55 year
All sexes
Interventional
Phase 3
Investigational Site Number 3920001, Koganeishi, Japan
The duration of each participant's participation in the study was approximately 30 to 44 days.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
*Effective methods of contraception included oral contraception (pill), intrauterine device, or condoms used with spermicide.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Pharmaceutical form: Liquid solution Route of administration: IM
Pharmaceutical form: Liquid solution Route of administration: IM
Other names: Menactra®
Time frame: Day 30 (post-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by serum bactericidal assay using human complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (>=) 1:16 for participants with pre-vaccination hSBA titer less than (<) 1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >= 1:8.
Time frame: Day 30 (post-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer >=1:16 for participants with pre-vaccination hSBA titer <1:8, or a >= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer >= 1:8.
Time frame: Day 0 (pre-vaccination); Day 30 (post-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Percentage of participants With hSBA antibody titers >=1:4 and >=1:8 for serogroups A, C, Y, and W were reported in the outcome measure.
Time frame: Day 0 (pre-vaccination); Day 30 (post-vaccination)
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Time frame: Day 30 (post-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Percentage of participants with hSBA titers <1:4, 1:4, 1:8, 1:16,1:32, 1:64, 1:128, 1:256, 1:512, 1:1024, 1:2048 and 1:4096 for serogroups A, C, Y, and W; with hSBA titers of 1:8192 for serogroup Y; and with hSBA titers of 1:8192, 1:16384, 1:32768 for serogroup C were reported.
Time frame: From Baseline (Day 0) to Day 30 (post-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Time frame: Within 30 minutes post-vaccination
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Time frame: Within 7 days post-vaccination
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions included pain, erythema, swelling, and induration. Solicited systemic reactions included fever, headache, malaise and myalgia.
Time frame: Up to 30 days post-vaccination
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.
Time frame: From Day 0 up to 30 days post-vaccination
An SAE was any untoward medical occurrence 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 an important medical event.
Sanofi
Industry
Immunogenicity and Safety of a Single Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03890367
Meningococcal Immunisation (Healthy Volunteers)
Aarhus, Denmark
View Trial DetailsNCT04084769
Meningococcal Immunisation (Healthy Volunteers)
Birmingham, Alabama, United States
View Trial Details