Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years

NCT ID: NCT03077438

Last Updated: 2022-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-17
• Study Completion Date: 2017-10-10

Brief Summary

The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) vaccine in children 2 to 9 years of age in the United States (US) and Puerto Rico.

Primary objective:

• To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine compared to that observed following the administration of a single dose of MENVEO® in children aged 2 to 9 years.

Secondary objectives:

• To compare the serum bactericidal assay using human complement (hSBA) antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of MENVEO® in children 2 to 9 years of age.
• To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine and those observed following the administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively.
• To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively.

Observational objective:

• To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed MENVEO®.

Detailed Description

Healthy children were randomized and received a single dose of either MenACYW Conjugate vaccine or MENVEO®. They were assessed for immunogenicity at baseline (pre-vaccination) and at 30-44 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: QUADRUPLE

Study Groups

Group 1: MenACYW Conjugate Vaccine

Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.

Group Type: EXPERIMENTAL

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

Intervention Type: BIOLOGICAL

0.5 milliliter (mL), Intramuscular

Group 2: MENVEO® Vaccine

Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.

Group Type: ACTIVE_COMPARATOR

Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

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

0.5 milliliter (mL), Intramuscular

Intervention Type: BIOLOGICAL

Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

MenACYW Conjugate vaccine; MENVEO®

Eligibility Criteria

Inclusion Criteria

• Aged 2 to 9 years on the day of inclusion.
• Assent form had been signed and dated by the participant (as required by local regulations) and informed consent form had been signed and dated by parent(s) or guardian.
• Participant and parent/guardian were able to attend all scheduled visits and complied with all trial procedures.

Exclusion Criteria

• Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche.
• 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 might be received at least 2 weeks before or after the study investigational vaccines. This exception included monovalent, multivalent, live, and attenuated influenza vaccines.
• Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, Y, W; or meningococcal B serogroup containing 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, contraindicating intramuscular vaccination by the Investigator's judgment.
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion.
• Personal history of Guillain-Barré syndrome.
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
• 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's judgment) on the day of vaccination or febrile illness (temperature ≥100.4°F). A prospective participant should not be included in the study until the condition had 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 a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 9 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 Officer, MD

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Investigational Site

Birmingham, Alabama, United States

Investigational Site

Dothan, Alabama, United States

Investigational Site

Tucson, Arizona, United States

Investigational Site

Jonesboro, Arkansas, United States

Investigational Site

Anaheim, California, United States

Investigational Site

Downey, California, United States

Investigational Site

Paramount, California, United States

Investigational Site

San Diego, California, United States

Investigational Site

Council Bluffs, Iowa, United States

Investigational Site

Bardstown, Kentucky, United States

Investigational Site

Nicholasville, Kentucky, United States

Investigational Site

Metairie, Louisiana, United States

Investigational Site

Woburn, Massachusetts, United States

Investigational Site

Bridgeton, Missouri, United States

Investigational Site

Kansas City, Missouri, United States

Investigational Site

Omaha, Nebraska, United States

Investigational Site

Cincinnati, Ohio, United States

Investigational Site

Cleveland, Ohio, United States

Investigational Site

Dayton, Ohio, United States

Investigational Site

Fairfield, Ohio, United States

Investigational Site

Grants Pass, Oregon, United States

Investigational Site

Gresham, Oregon, United States

Investigational Site

Erie, Pennsylvania, United States

Investigational Site

Hermitage, Pennsylvania, United States

Investigational Site

Goodlettsville, Tennessee, United States

Investigational Site

Tullahoma, Tennessee, United States

Investigational Site

Layton, Utah, United States

Investigational Site

Orem, Utah, United States

Investigational Site

Roy, Utah, United States

Investigational Site

Salt Lake City, Utah, United States

Investigational Site

Salt Lake City, Utah, United States

Investigational Site

South Jordan, Utah, United States

Investigational Site

Syracuse, Utah, United States

Investigational Site

West Jordan, Utah, United States

Investigational Site

Midlothian, Virginia, United States

Investigational Site

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

References

Baccarini CI, Simon MW, Brandon D, Christensen S, Jordanov E, Dhingra MS. Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Meningococcal-Naive Children 2-9 Years of Age: A Phase III, Randomized Study. Pediatr Infect Dis J. 2020 Oct;39(10):955-960. doi: 10.1097/INF.0000000000002832.

Reference Type: DERIVED

PMID: 32852352 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

U1111 1161 2625

Identifier Type: OTHER

Identifier Source: secondary_id

MET35

Identifier Type: -

Identifier Source: org_study_id