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Booster vaccine for meningitis shows promise in seniors

NCT ID NCT04142242

Vaccine Sponsor: Sanofi Pasteur, a Sanofi Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a single booster dose of the MenACYW conjugate vaccine in 471 older adults who had received either an older or the same vaccine at least 3 years earlier. The goal was to see if the booster triggered a strong immune response against four meningitis-causing bacteria groups. Results showed that the booster effectively raised antibody levels, suggesting it could help maintain protection in older adults.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW, MenQuadfi)
What this could lead to
If successful, this could confirm that a booster dose of MenACYW vaccine effectively protects older adults against meningococcal infection years after their first shot.
What could go wrong
This trial is completed and focused on immune response, not long-term disease prevention. Results may not apply to all older adults or different vaccine schedules.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

471 people

The number who actually took part.

Started

Oct 2019

Finished

May 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

59 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * 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. Exclusion criteria: * 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. Note: "Active phase" refers to the 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. Accordingly, following the blood draw at Visit 1, participants in Group 3 and Group 4 will have a 2-year inactive phase prior to Visit 2. Prior to Visit 2, participants in Group 3 and Group 4 will have inclusion and exclusion criteria reassessed and will continue with or be excluded from further participation in the trial as appropriate. * 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.

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Conditions

The condition(s) this trial relates to.

meningococcal infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Meningococcal infection (healthy volunteers)

Contacts and locations

Locations

  • Investigational Site Number 6300001

    San Juan, 00981, Puerto Rico

  • Investigational Site Number 8400001

    Murray, Utah, 84123, United States

  • Investigational Site Number 8400002

    Salt Lake City, Utah, 84107, United States

  • Investigational Site Number 8400003

    San Diego, California, 92123-1881, United States

  • Investigational Site Number 8400004

    Charlottesville, Virginia, 22911, United States

  • Investigational Site Number 8400005

    Cincinnati, Ohio, 45246, United States

  • Investigational Site Number 8400007

    Jacksonville, Florida, 32205, United States

  • Investigational Site Number 8400010

    Elkridge, Maryland, 21075, United States

  • Investigational Site Number 8400011

    Columbus, Ohio, 43212, United States

  • Investigational Site Number 8400012

    Raleigh, North Carolina, 27612, United States

  • Investigational Site Number 8400013

    Fargo, North Dakota, 58104, United States

  • Investigational Site Number 8400014

    Uniontown, Pennsylvania, 15401, United States

  • Investigational Site Number 8400015

    Jacksonville, Florida, 32216, United States

  • Investigational Site Number 8400016

    Metairie, Louisiana, 70006, United States

  • Investigational Site Number 8400017

    Wichita, Kansas, 67205, United States

  • Investigational Site Number 8400018

    Anderson, South Carolina, 29621, United States

  • Investigational Site Number 8400019

    Endwell, New York, 13760, United States

  • Investigational Site Number 8400020

    West Palm Beach, Florida, 33409, United States

  • Investigational Site Number 8400021

    Greensboro, North Carolina, 27408, United States

  • Investigational Site Number 8400022

    Ponte Vedra, Florida, 32081, United States

  • Investigational Site Number 8400023

    DeLand, Florida, 32720, United States

  • Investigational Site Number 8400024

    Dallas, Texas, 75231, United States

  • Investigational Site Number 8400025

    West Jordan, Utah, 84088-8865, United States

  • Investigational Site Number 8400026

    Chandler, Arizona, 85225, United States

  • Investigational Site Number 8400027

    Newton, Kansas, 67114, United States

  • Investigational Site Number 8400028

    Waterbury, Connecticut, 06708, United States

  • Investigational Site Number 8400030

    St Louis, Missouri, 63141, United States

  • Investigational Site Number 8400031

    Richfield, Minnesota, 55423, United States

  • Investigational Site Number 8400032

    Port Orange, Florida, 32127, United States

  • Investigational Site Number 8400033

    Winston-Salem, North Carolina, 27103, United States

  • Investigational Site Number 8400034

    Mt. Pleasant, South Carolina, 29464, United States

  • Investigational Site Number 8400035

    Cincinnati, Ohio, 45241, United States

  • Investigational Site Number 8400036

    Mt. Pleasant, South Carolina, 29464, United States

  • Investigational Site Number 8400038

    Clearwater, Florida, 33756, United States