Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine in Older Adults Who Received a Primary Vaccination (3 or More Years Earlier) in Study MET49

NCT04142242 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: MEQ00066U1111-1217-2058
• Study Type: interventional
• Target: 471
• Locations: 2 countries
• Sites: 34

Brief Summary

Primary Objective: To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine to Group 1 participants (who received primary vaccination with Menomune vaccine greater than or equal to \[\>= 3\] years earlier at \>= 56 years of age in Study MET49). Secondary Objectives: Secondary Objective 1 - To demonstrate sufficiency of the vaccine seroresponse to meningococcal serogroups A, C, W, and Y following administration of a single dose of MenACYW Conjugate vaccine to Group 2 participants (who received primary vaccination with MenACYW Conjugate vaccine \>= 3 years earlier at \>= 56 years of age in Study MET49). Secondary Objective 2 - To describe vaccine seroresponse rates with respect to serogroups A, C, W, and Y in serum specimens collected 6 days (window, 5-7) post-vaccination in approximately 60 participants from Group 1 (Menomune-primed) and approximately 60 participants from Group 2 (MenACYW Conjugate vaccine-primed). Secondary Objective 3 - To describe antibody persistence \>= 3 years after primary vaccination with Menomune vaccine or MenACYW Conjugate vaccine for participants from all groups.

Conditions

Meningococcal Infection (Healthy Volunteers)

Outcome Measures

Primary Outcomes (1)

• Stage I: Percentage of Participants With Seroresponse for Meningococcal Serogroups A, C, W & Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 1 (Menomune-primed)

  Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.

  Day 30 (post-vaccination) in study MEQ00066

Secondary Outcomes (9)

• Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 2 (MenACYW Conjugate Vaccine-primed Participants)

  Day 30 (post-vaccination) in study MEQ00066

• Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA at Day 6 After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Groups 1 and 2

  Day 6 (post-vaccination) in study MEQ00066

• Stage I: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Before and After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066 (Groups 1 to 4)

  Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MEQ00066

• Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6

  Day 0 (pre-vaccination in MEQ00066)

• Stage I: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 1 to 6

  Day 0 (pre-vaccination) in study MEQ00066

Study Arms (6)

Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)

EXPERIMENTAL

Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0, during Stage I in the present study (MEQ00066).

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

Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)

EXPERIMENTAL

Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence (at enrollment \[Day 0\]) followed by a single IM dose of MenACYW Conjugate vaccine at Day 0, during Stage I in the present study (MEQ00066).

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

Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)

EXPERIMENTAL

Participants who received a single dose of Menomune vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).

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

Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)

EXPERIMENTAL

Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET49, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066), followed by receiving a single IM dose of MenACYW Conjugate vaccine at Stage II in the present study (MEQ00066).

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

Group 5: Menomune-primed Participants (MET44)

OTHER

Participants who received a single dose of Menomune vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).

Other: Blood sample

Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)

OTHER

Participants who received a single dose of MenACYW Conjugate vaccine in a previous study MET44, provided a blood sample for assessment of antibody persistence at enrollment (Day 0) during Stage I in the present study (MEQ00066). These participants did not receive any vaccination in the present study (MEQ00066).

Other: Blood sample

Interventions

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

Pharmaceutical form: Solution for injection; Route of administration: Intramuscular

Also known as: MenACYW Conjugate vaccine, MenQuadfi

Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants); Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants); Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants); Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)

Blood sample OTHER

Blood sample for assessment of antibody persistence.

Group 5: Menomune-primed Participants (MET44); Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)

Eligibility Criteria

• Age: 59 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Received primary vaccination in Study MET49 or Study MET44 at \>= 56 years of age with either Menomune vaccine or MenACYW Conjugate vaccine, as assigned by randomization. ("\>= 56 years" means from the day of the 56th birthday onwards).
• Able to attend all scheduled visits and to comply with all study procedures.

You may not qualify if:

• 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 and until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, or surgically sterile.
• Participation in the 4 weeks preceding study enrollment/vaccination or planned participation during the active phase of the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks (28 days) preceding the study vaccination or planned receipt of any vaccine during the active phase of the present study except for influenza vaccination, which might be received at least 2 weeks before or after study vaccine. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
• Receipt or planned receipt of any meningococcal vaccine since receipt of a single dose of MenACYW Conjugate vaccine or Menomune vaccine in Study MET49 or Study MET44.
• Receipt of immune globulins, blood, or blood-derived products in the 3 months prior to either enrollment or MenACYW Conjugate vaccination in the current study.
• 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 prior either to enrollment or MenACYW conjugate vaccination in the current study).
• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
• At high risk for meningococcal infection during the study (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 used in the study or to a vaccine containing any of the same substances (excluding participants in Group 5 and Group 6).
• Verbal report of thrombocytopenia, contraindicating IM vaccination, in the Investigator's opinion (excluding participants in Group 5 and Group 6).
• Personal history of Guillain-Barré Syndrome (GBS) (excluding participants in Group 5 and Group 6).
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination (excluding participants in Group 5 and Group 6).
• Current alcohol abuse or drug addiction.
• Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion.
• Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature \>= 100.4°F). A prospective participant should not be included in the study or receive study vaccination until the condition has resolved or the febrile event has subsided.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (34)

Investigational Site Number 8400026

Chandler, Arizona, 85225, United States

Location

Investigational Site Number 8400003

San Diego, California, 92123-1881, United States

Location

Investigational Site Number 8400028

Waterbury, Connecticut, 06708, United States

Location

Investigational Site Number 8400038

Clearwater, Florida, 33756, United States

Location

Investigational Site Number 8400023

DeLand, Florida, 32720, United States

Location

Investigational Site Number 8400007

Jacksonville, Florida, 32205, United States

Location

Investigational Site Number 8400015

Jacksonville, Florida, 32216, United States

Location

Investigational Site Number 8400022

Ponte Vedra, Florida, 32081, United States

Location

Investigational Site Number 8400032

Port Orange, Florida, 32127, United States

Location

Investigational Site Number 8400020

West Palm Beach, Florida, 33409, United States

Location

Investigational Site Number 8400027

Newton, Kansas, 67114, United States

Location

Investigational Site Number 8400017

Wichita, Kansas, 67205, United States

Location

Investigational Site Number 8400016

Metairie, Louisiana, 70006, United States

Location

Investigational Site Number 8400010

Elkridge, Maryland, 21075, United States

Location

Investigational Site Number 8400031

Richfield, Minnesota, 55423, United States

Location

Investigational Site Number 8400030

St Louis, Missouri, 63141, United States

Location

Investigational Site Number 8400019

Endwell, New York, 13760, United States

Location

Investigational Site Number 8400021

Greensboro, North Carolina, 27408, United States

Location

Investigational Site Number 8400012

Raleigh, North Carolina, 27612, United States

Location

Investigational Site Number 8400033

Winston-Salem, North Carolina, 27103, United States

Location

Investigational Site Number 8400013

Fargo, North Dakota, 58104, United States

Location

Investigational Site Number 8400035

Cincinnati, Ohio, 45241, United States

Location

Investigational Site Number 8400005

Cincinnati, Ohio, 45246, United States

Location

Investigational Site Number 8400011

Columbus, Ohio, 43212, United States

Location

Investigational Site Number 8400014

Uniontown, Pennsylvania, 15401, United States

Location

Investigational Site Number 8400018

Anderson, South Carolina, 29621, United States

Location

Investigational Site Number 8400034

Mt. Pleasant, South Carolina, 29464, United States

Location

Investigational Site Number 8400036

Mt. Pleasant, South Carolina, 29464, United States

Location

Investigational Site Number 8400024

Dallas, Texas, 75231, United States

Location

Investigational Site Number 8400001

Murray, Utah, 84123, United States

Location

Investigational Site Number 8400002

Salt Lake City, Utah, 84107, United States

Location

Investigational Site Number 8400025

West Jordan, Utah, 84088-8865, United States

Location

Investigational Site Number 8400004

Charlottesville, Virginia, 22911, United States

Location

Investigational Site Number 6300001

San Juan, 00981, Puerto Rico

Location

Related Publications (2)

• Robertson CA, Jacqmein J, Selmani A, Galarza K, Oster P. Immune persistence and booster response of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) 5 years after primary vaccination of adults at >/=56 years of age. Hum Vaccin Immunother. 2024 Dec 31;20(1):2426868. doi: 10.1080/21645515.2024.2426868. Epub 2024 Nov 18.

  PMID: 39555800 DERIVED

• Robertson CA, Jacqmein J, Selmani A, Galarza K, Oster P. Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered as a booster to adults aged >/=59 years: A phase III randomized study. Hum Vaccin Immunother. 2023 Dec 31;19(1):2160600. doi: 10.1080/21645515.2022.2160600. Epub 2023 Jan 11.

  PMID: 36632042 DERIVED

Related Links

• MEQ00066 Plain Language Results Summary

MeSH Terms

Conditions

Meningococcal Infections

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  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: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 29, 2019
• Study Start: October 4, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 25, 2022
• Last Updated: September 11, 2025
• Results First Posted: April 26, 2021

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); US (33)