Phase 3 N=3,344 Randomized Double-blind Prevention

Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

Meningitis · Meningococcal Meningitis · Meningococcal Infections

Bottom Line

View on ClinicalTrials.gov: NCT02842853 ↗

Enrolled (actual)

3,344

Serious AEs

1.0%

Results posted

Mar 2020

Primary outcome: Primary: Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine — 84.9; 96.5; 97.9; 326 Titer (1/dilution)

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (Biological); Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Biological)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: Sanofi Pasteur, a Sanofi Company
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine	84.9; 96.5; 97.9; 326; 305; 352	—
PRIMARY Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine	73.8; 54.6; 88.8; 47.9; 91.4; 73.4	—
SECONDARY Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults	73.5; 53.9; 83.4; 42.3; 88.1; 60.8	—
SECONDARY Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adolescents	74.0; 55.3; 95.6; 53.3; 95.6; 85.7	—
SECONDARY Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine	71.1; 76.5; 73.7; 90.5; 89.1; 86.7	—
SECONDARY Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra®	92.9; 48.1; 328; 40.7; 214; 66.4	—

Summary

The purpose of the study was to evaluate immune lot consistency of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine and the immune non-inferiority compared to the licensed vaccine Menactra®, and describe the safety and additional immunogenicity of these study vaccines in adolescents and adults 10 to 55 years of age in the United States (US). Primary Objectives: * To demonstrate the immune lot consistency of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine with respect to serum bactericidal assay using human complement (hSBA) geometric mean titers (GMTs). * 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 MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra®. Secondary 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 MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra® in the adult population (18 to 55 years old). * 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 MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra® in the adolescent population (10 to 17 years old). * To compare the hSBA vaccine seroresponses of meningococcal serogroups A, C, Y, and W for each of 3 lots of MenACYW Conjugate vaccine 30 days (+14 days) after vaccination. * To compare the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of Menactra®. Observational Objectives: * To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed Menactra®.

Eligibility Criteria

Inclusion Criteria

Aged 10 to 55 years on the day of inclusion.
Informed consent form was signed and dated by the participant (aged 18 to 55 years) or assent form was signed and dated by the participant and informed consent form was signed and dated by the parent(s) or guardian (for participants aged 10 to = 18 years) or participant (10 to = 100.4 degree Fahrenheit [°F]). A prospective participant was not be included in the study until the condition was resolved or the febrile event had subsided.
Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
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 (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.

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Data sourced from ClinicalTrials.gov (NCT02842853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.