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

NCT ID: NCT02842853

Last Updated: 2022-04-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3344 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-15
• Study Completion Date: 2017-02-28

Brief 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®.

Detailed Description

Healthy meningococcal-vaccine naïve adolescents and adults were randomized and received a single dose of either MenACYW Conjugate vaccine from 1 of the 3 lots (Lot 1, Lot 2, or Lot 3) or Menactra®. They were assessed for immunogenicity at baseline (pre-vaccination) and at 30 to 44 days post-vaccination. Safety information were collected post-vaccination and throughout the entire study.

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 Lot 1

Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 1a) and adults aged 18 to 55 years (Group 1b) received a single dose of MenACYW conjugate vaccine from lot 1 on Day 0.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

MenACYW Conjugate Vaccine Lot 2

Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 2a) and adults aged 18 to 55 years (Group 2b) received a single dose of MenACYW conjugate vaccine from lot 2 on Day 0.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

MenACYW Conjugate Vaccine Lot 3

Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 3a) and adults aged 18 to 55 years (Group 3b) received a single dose of MenACYW conjugate vaccine from lot 3 on Day 0.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Menactra®

Healthy, meningococcal-vaccine naive adolescents aged 10 to 17 years (Group 4a) and adults aged 18 to 55 years (Group 4b) received a single dose of Menactra® 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 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 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).
• Participant (>= 18 years) or participant (10 to < 18 years) and parent / guardian were able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria

• Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must have been 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 prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or 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 traveling 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 vaccines used in the trial or to a vaccine containing any of the same substances.
• Verbal report of thrombocytopenia, as reported by the participant or the participant's parent / guardian, 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.
• Personal history of Guillain-Barre syndrome.
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study vaccination.
• 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, was at a stage where it might interfere with trial conduct or completion.
• Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 55 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

Birmingham, Alabama, United States

Dothan, Alabama, United States

Mobile, Alabama, United States

Glendale, Arizona, United States

Mesa, Arizona, United States

Phoenix, Arizona, United States

Harrisburg, Arkansas, United States

Jonesboro, Arkansas, United States

Anaheim, California, United States

Downey, California, United States

Los Angeles, California, United States

Paramount, California, United States

Redding, California, United States

Sacramento, California, United States

San Diego, California, United States

San Diego, California, United States

San Diego, California, United States

Santa Rosa, California, United States

Upland, California, United States

West Covina, California, United States

Littleton, Colorado, United States

DeLand, Florida, United States

Hialeah, Florida, United States

Hialeah, Florida, United States

Miami, Florida, United States

Orlando, Florida, United States

Sarasota, Florida, United States

South Miami, Florida, United States

St. Petersburg, Florida, United States

West Palm Beach, Florida, United States

Savannah, Georgia, United States

Meridian, Idaho, United States

Council Bluffs, Iowa, United States

Lenexa, Kansas, United States

Newton, Kansas, United States

Park City, Kansas, United States

Wichita, Kansas, United States

Wichita, Kansas, United States

Bardstown, Kentucky, United States

Metairie, Louisiana, United States

Bridgeton, Missouri, United States

Kansas City, Missouri, United States

St Louis, Missouri, United States

Lincoln, Nebraska, United States

Lincoln, Nebraska, United States

Omaha, Nebraska, United States

Omaha, Nebraska, United States

Charlotte, North Carolina, United States

Raleigh, North Carolina, United States

Raleigh, North Carolina, United States

Salisbury, North Carolina, United States

Fargo, North Dakota, United States

Cincinnati, Ohio, United States

Cincinnati, Ohio, United States

Cleveland, Ohio, United States

Dayton, Ohio, United States

Dayton, Ohio, United States

Corvallis, Oregon, United States

Grants Pass, Oregon, United States

Erie, Pennsylvania, United States

Hermitage, Pennsylvania, United States

McMurray, Pennsylvania, United States

Upper Saint Clair, Pennsylvania, United States

Warwick, Rhode Island, United States

Charleston, South Carolina, United States

Charleston, South Carolina, United States

Mt. Pleasant, South Carolina, United States

Jackson, Tennessee, United States

Nashville, Tennessee, United States

Tullahoma, Tennessee, United States

Corpus Christi, Texas, United States

Fort Worth, Texas, United States

Fort Worth, Texas, United States

San Antonio, Texas, United States

Waxahachie, Texas, United States

Draper, Utah, United States

Layton, Utah, United States

Murray, Utah, United States

Orem, Utah, United States

Salt Lake City, Utah, United States

Salt Lake City, Utah, United States

South Jordan, Utah, United States

West Jordan, Utah, United States

West Jordan, Utah, United States

Burke, Virginia, United States

Charlottesville, Virginia, United States

Charlottesville, Virginia, United States

Midlothian, Virginia, United States

Richmond, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

U1111-1161-3060

Identifier Type: OTHER

Identifier Source: secondary_id

MET43

Identifier Type: -

Identifier Source: org_study_id