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
NCT ID: NCT04142242
Last Updated: 2025-09-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
471 participants
INTERVENTIONAL
2019-10-04
2022-05-25
Brief Summary
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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.
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Detailed Description
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Study duration per participant in Group 3 and 4 was approximately 2 years and 30 days including: 1 day of screening, 1 day of vaccination 2 years later, a phone call and a safety-follow up/end of study visit at Day 8 and Day 30 after vaccine administration, respectively.
Study duration per participant in Group 5 and 6 was 1 day.
Safety assessment includes solicited reactions within 7 days after vaccination, unsolicited adverse events (AEs), serious adverse events (SAEs) and adverse event of special interest (AESI)s throughout the study "active phase" (i.e., period of time from revaccination with MenACYW Conjugate vaccine to the end of the short-term \[i.e., \~30 days\] follow-up after the vaccination).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)
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).
Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Pharmaceutical form: Solution for injection; Route of administration: Intramuscular
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)
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).
Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Pharmaceutical form: Solution for injection; Route of administration: Intramuscular
Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)
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).
Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Pharmaceutical form: Solution for injection; Route of administration: Intramuscular
Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)
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).
Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Pharmaceutical form: Solution for injection; Route of administration: Intramuscular
Group 5: Menomune-primed Participants (MET44)
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).
Blood sample
Blood sample for assessment of antibody persistence.
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)
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).
Blood sample
Blood sample for assessment of antibody persistence.
Interventions
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Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Pharmaceutical form: Solution for injection; Route of administration: Intramuscular
Blood sample
Blood sample for assessment of antibody persistence.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to attend all scheduled visits and to comply with all study procedures.
Exclusion Criteria
* 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).
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion (excluding participants in Group 5 and Group 6), contraindicating IM vaccination in the Investigator's opinion.
* 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.
* 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.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
59 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Investigational Site Number 8400026
Chandler, Arizona, United States
Investigational Site Number 8400003
San Diego, California, United States
Investigational Site Number 8400028
Waterbury, Connecticut, United States
Investigational Site Number 8400038
Clearwater, Florida, United States
Investigational Site Number 8400023
DeLand, Florida, United States
Investigational Site Number 8400007
Jacksonville, Florida, United States
Investigational Site Number 8400015
Jacksonville, Florida, United States
Investigational Site Number 8400022
Ponte Vedra, Florida, United States
Investigational Site Number 8400032
Port Orange, Florida, United States
Investigational Site Number 8400020
West Palm Beach, Florida, United States
Investigational Site Number 8400027
Newton, Kansas, United States
Investigational Site Number 8400017
Wichita, Kansas, United States
Investigational Site Number 8400016
Metairie, Louisiana, United States
Investigational Site Number 8400010
Elkridge, Maryland, United States
Investigational Site Number 8400031
Richfield, Minnesota, United States
Investigational Site Number 8400030
St Louis, Missouri, United States
Investigational Site Number 8400019
Endwell, New York, United States
Investigational Site Number 8400021
Greensboro, North Carolina, United States
Investigational Site Number 8400012
Raleigh, North Carolina, United States
Investigational Site Number 8400033
Winston-Salem, North Carolina, United States
Investigational Site Number 8400013
Fargo, North Dakota, United States
Investigational Site Number 8400035
Cincinnati, Ohio, United States
Investigational Site Number 8400005
Cincinnati, Ohio, United States
Investigational Site Number 8400011
Columbus, Ohio, United States
Investigational Site Number 8400014
Uniontown, Pennsylvania, United States
Investigational Site Number 8400018
Anderson, South Carolina, United States
Investigational Site Number 8400034
Mt. Pleasant, South Carolina, United States
Investigational Site Number 8400036
Mt. Pleasant, South Carolina, United States
Investigational Site Number 8400024
Dallas, Texas, United States
Investigational Site Number 8400001
Murray, Utah, United States
Investigational Site Number 8400002
Salt Lake City, Utah, United States
Investigational Site Number 8400025
West Jordan, Utah, United States
Investigational Site Number 8400004
Charlottesville, Virginia, United States
Investigational Site Number 6300001
San Juan, , Puerto Rico
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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MEQ00066 Plain Language Results Summary
Other Identifiers
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U1111-1217-2058
Identifier Type: OTHER
Identifier Source: secondary_id
MEQ00066
Identifier Type: -
Identifier Source: org_study_id
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