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

NCT ID: NCT02752906

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 810 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-15
• Study Completion Date: 2016-12-19

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.

Detailed Description

Healthy adolescents and adults who had received 1 dose of a quadrivalent meningococcal Conjugate vaccine 4 to 10 years previously were randomized to receive either 1 dose of MenACYW Conjugate vaccine or licensed Menactra®. All participants underwent immunogenicity assessment at baseline (pre-vaccination) and post-vaccination and were also evaluated for safety up to Day 180 post-vaccination. In addition, a subset had an additional blood sample collected at 6 days post-vaccination for immunogenicity assessment.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

MenACYW Conjugate Vaccine

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 milliliter (mL), Intramuscular

Menactra®

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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

0.5 milliliter (mL), Intramuscular

Intervention Type: BIOLOGICAL

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

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

MenACYW Conjugate vaccine; Menactra®

Eligibility Criteria

Inclusion Criteria

• Aged >= 15 years on the day of inclusion.
• 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.

Exclusion Criteria

• 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.
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 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.
• Moderate or severe acute illness/infection (according to the Investigator's judgment) on the day of vaccination or febrile illness (temperature >= 100.4°Fahrenheit [F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has 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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Investigational Site Number 016

Birmingham, Alabama, United States

Investigational Site Number 032

Dothan, Alabama, United States

Investigational Site Number 026

Mesa, Arizona, United States

Investigational Site Number 022

Jonesboro, Arkansas, United States

Investigational Site Number 005

Downey, California, United States

Investigational Site Number 014

La Puente, California, United States

Investigational Site Number 029

San Diego, California, United States

Investigational Site Number 001

San Diego, California, United States

Investigational Site Number 013

Bardstown, Kentucky, United States

Investigational Site Number 027

Nicholasville, Kentucky, United States

Investigational Site Number 015

Metairie, Louisiana, United States

Investigational Site Number 018

Woburn, Massachusetts, United States

Investigational Site Number 010

Troy, Michigan, United States

Investigational Site Number 008

Kansas City, Missouri, United States

Investigational Site Number 028

St Louis, Missouri, United States

Investigational Site Number 023

Lincoln, Nebraska, United States

Investigational Site Number 031

Omaha, Nebraska, United States

Investigational Site Number 006

Rochester, New York, United States

Investigational Site Number 012

Fargo, North Dakota, United States

Investigational Site Number 019

Cincinnati, Ohio, United States

Investigational Site Number 011

Fairfield, Ohio, United States

Investigational Site Number 025

Huber Heights, Ohio, United States

Investigational Site Number 021

Kettering, Ohio, United States

Investigational Site Number 009

Erie, Pennsylvania, United States

Investigational Site Number 007

Hermitage, Pennsylvania, United States

Investigational Site Number 024

Tullahoma, Tennessee, United States

Investigational Site Number 020

Salt Lake City, Utah, United States

Investigational Site Number 003

Salt Lake City, Utah, United States

Investigational Site Number 017

South Jordan, Utah, United States

Investigational Site Number 030

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

References

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.

Reference Type: RESULT

PMID: 32209015 (View on PubMed)

Other Identifiers

U1111-1161-2710

Identifier Type: OTHER

Identifier Source: secondary_id

2018-001470-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MET56

Identifier Type: -

Identifier Source: org_study_id