Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine

NCT02752906 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: MET56U1111-1161-27102018-001470-18
• Study Type: interventional
• Target: 810
• Locations: 2 countries
• Sites: 30

Brief Summary

The aim of the study was to describe the safety and antibody response to booster administration with Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in participants who received their first quadrivalent meningococcal Conjugate vaccine dose in the past 4-10 years. Primary Objective:

• To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW Conjugate vaccine compared to those observed following the administration of a booster dose of Menactra® in participants who were first vaccinated with 1 dose of a quadrivalent meningococcal vaccine 4 to 10 years before the booster dose. Secondary Objectives:
• To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after vaccination in a subset of 120 participants.
• To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination. Observational Objectives:
• To describe the antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination.
• To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days after vaccination with MenACYW Conjugate vaccine or Menactra® measured by rabbit serum bactericidal assay (rSBA) in a subset of participants.
• To describe the safety profile of MenACYW Conjugate vaccine compared to that of a licensed Menactra® after booster vaccination.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Keywords

Meningitis; Meningococcal Meningitis; Meningococcal Infections; MenACYW Conjugate vaccine; Licensed Meningococcal Conjugate Vaccine (MCV4)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine

  The serum bactericidal assay using human complement (hSBA) vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>= 1:16 for participants with pre-vaccination hSBA titers \< 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>= 1:8.

  Day 30 (post-vaccination)

Secondary Outcomes (3)

• Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 6 After Vaccination

  Day 6 (post-vaccination)

• Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine

  Day 30 (post-vaccination)

• Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine

  Within 7 days post-vaccination

Study Arms (2)

MenACYW Conjugate Vaccine

EXPERIMENTAL

Healthy, meningococcal vaccine-primed adolescents (greater than or equal to \[\>=\] 15 to less than \[\< \]18 years) or adults (\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.

Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine

Menactra®

ACTIVE COMPARATOR

Healthy, meningococcal- vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of Menactra ® vaccine on Day 0.

Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine

Interventions

Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine BIOLOGICAL

0.5 milliliter (mL), Intramuscular

Also known as: MenACYW Conjugate vaccine

MenACYW Conjugate Vaccine

Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®

Menactra®

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has documented record of having received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years prior to study vaccination.
• Participant aged 15 to \< 18 years: assent form signed and dated by the participant and informed consent form (ICF) signed and dated by the parent or guardian.
• Participant aged \>=18 years: ICF signed and dated by the participant.
• Participants aged 15 to \< 18 years: both the participant and parent / guardian were able to attend all scheduled visits and to comply with all trial procedures.
• Participants aged \>= 18 years: able to attend all scheduled visits and to comply with all trial procedures.

You may not qualify if:

• Participant was pregnant, lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).
• Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine before Day 30 visit except for influenza vaccination, which may be received at least 2 weeks before study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• Previous vaccination against meningococcal disease with either an investigational or approved meningococcal B vaccine.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
• At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease).
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances.
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
• Personal history of Guillain-Barré syndrome.
• Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the Investigator's opinion.
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• Current alcohol abuse or drug addiction.
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (30)

Investigational Site Number 016

Birmingham, Alabama, 35205, United States

Location

Investigational Site Number 032

Dothan, Alabama, 36305, United States

Location

Investigational Site Number 026

Mesa, Arizona, 85213, United States

Location

Investigational Site Number 022

Jonesboro, Arkansas, 72401, United States

Location

Investigational Site Number 005

Downey, California, 90241, United States

Location

Investigational Site Number 014

La Puente, California, 91744, United States

Location

Investigational Site Number 029

San Diego, California, 92108, United States

Location

Investigational Site Number 001

San Diego, California, 92123-1881, United States

Location

Investigational Site Number 013

Bardstown, Kentucky, 40004, United States

Location

Investigational Site Number 027

Nicholasville, Kentucky, 40356, United States

Location

Investigational Site Number 015

Metairie, Louisiana, 70006, United States

Location

Investigational Site Number 018

Woburn, Massachusetts, 01801, United States

Location

Investigational Site Number 010

Troy, Michigan, 48098, United States

Location

Investigational Site Number 008

Kansas City, Missouri, 64114, United States

Location

Investigational Site Number 028

St Louis, Missouri, 63141, United States

Location

Investigational Site Number 023

Lincoln, Nebraska, 68504, United States

Location

Investigational Site Number 031

Omaha, Nebraska, 68144, United States

Location

Investigational Site Number 006

Rochester, New York, 14609, United States

Location

Investigational Site Number 012

Fargo, North Dakota, 58104, United States

Location

Investigational Site Number 019

Cincinnati, Ohio, 45245, United States

Location

Investigational Site Number 011

Fairfield, Ohio, 45014, United States

Location

Investigational Site Number 025

Huber Heights, Ohio, 45424, United States

Location

Investigational Site Number 021

Kettering, Ohio, 45429, United States

Location

Investigational Site Number 009

Erie, Pennsylvania, 16508, United States

Location

Investigational Site Number 007

Hermitage, Pennsylvania, 16148, United States

Location

Investigational Site Number 024

Tullahoma, Tennessee, 37388, United States

Location

Investigational Site Number 020

Salt Lake City, Utah, 84109, United States

Location

Investigational Site Number 003

Salt Lake City, Utah, 84121, United States

Location

Investigational Site Number 017

South Jordan, Utah, 84095, United States

Location

Investigational Site Number 030

San Juan, 00981, Puerto Rico

Location

Related Publications (1)

• Anez G, Hedrick J, Simon MW, Christensen S, Jeanfreau R, Yau E, Pan J, Jordanov E, Dhingra MS. Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study. Hum Vaccin Immunother. 2020 Jun 2;16(6):1292-1298. doi: 10.1080/21645515.2020.1733867. Epub 2020 Mar 25.

  PMID: 32209015 RESULT

MeSH Terms

Conditions

Meningitis; Meningitis, Meningococcal; Meningococcal Infections

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur Inc.

Contact-US@sanofi.com

800-633-1610

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: April 27, 2016
• Study Start: April 15, 2016
• Primary Completion: December 19, 2016
• Study Completion: December 19, 2016
• Last Updated: April 5, 2022
• Results First Posted: June 5, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (29); PR (1)