MeningitisPhase 2NCT01732627

Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older

A Phase 2 study testing Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine and Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined in people with Meningitis and Meningococcal Meningitis, run by Sanofi Pasteur, a Sanofi Company at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary objectives: To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein (MenACYW) Conjugate… Read more about this study

Who is it for?: Ages 56 years and olderHealthy volunteers can take part
Conditions the study is for: Meningitis, Meningococcal Meningitis, Meningococcal Infections
What is being tested?: Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine and Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 301 participants
Where: 12 sitesUnited States
Study dates: 12 Nov 2012to 17 Jan 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 56 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Aged 56 or older on the day of inclusion.
Informed consent form had been signed and dated.
Able to attend all scheduled visits and complied with all trial procedures.

Who cannot join

Participant was pregnant, or lactating, or of childbearing potential (were considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination).
Participation at the time of study enrollment (or 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 preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination except for influenza vaccination, which might be received at least 2 weeks before or after the study vaccines.
Previous vaccination against meningococcal disease with either a trial vaccine or another 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).

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History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
At high risk for meningococcal infection during the trial.
Known systemic hypersensitivity to latex or any of the vaccine components, or history of a severe reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
Personal history of Guillain-Barré syndrome.
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.
Self-reported thrombocytopenia, contraindicating IM vaccination.
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM 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°Fahrenheit [≥ 38.0°Celsius]). 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 3 days prior to any blood draw. Should a participant receive oral or injectable antibiotic therapy within 3 days prior to any blood draw, the Investigator would postpone the blood draw until it had been 3 days since the participant last received oral or injectable antibiotic therapy. Postponement must still be within the timeframe for blood draw indicated in the Table of Study Procedures, when possible.
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.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Study site
Anderson, South Carolina, 29621
Study site
Chandler, Arizona, 85224
Study site
Charlottesville, Virginia, 22911
Study site
Columbus, Ohio, 43212
Study site
Denver, Colorado, 80239
Study site
Edina, Minnesota, 55435
Study site
Milford, Connecticut, 06460
Study site
Murray, Utah, 84123
Study site
Salt Lake City, Utah, 84124
Study site
Scottsdale, Arizona, 85251
Study site
St Louis, Missouri, 63141
Study site
West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Subjects 56 Years of Age and Older

Primary objectives:

To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135.
To describe the safety profile of a single dose of MenACYW Conjugate vaccine or Menomune® - A/C/Y/W 135.

Read the detailed description

All participants received a single dose of their assigned vaccine on Day 0. They were assessed for immunogenicity on Day 0 and Day 30, and monitored for safety throughout the study.

Conditions: Meningitis, Meningococcal Meningitis, Meningococcal Infections, Invasive Meningococcal Disease
Being tested: Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine, Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined
Keywords: Meningitis, Meningococcal Meningitis, Menactra®, Menomune® A/C/Y/W 135
Medical subject headings: Meningitis, Meningitis, Meningococcal, Meningococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate VaccineBiological
Also called MenACYW Conjugate Vaccine
0.5 milliliter (mL), Intramuscular (IM)
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 CombinedBiological
Also called Menomune® A/C/Y/W 135
0.5 mL, Subcutaneous (SC)

Study groups in NCT01732627
Study group	Role	What they receive
Group 1: MenACYW Conjugate Vaccine	Experimental	Adult participants aged greater than or equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0. Receives: Biological: Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine
Group 2: Menomune® A/C/Y/W 135 vaccine	Active comparator	Adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined (Menomune®) vaccine on Day 0. Receives: Biological: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Measured: Day 0 (pre-vaccination)
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Measured: Day 30 (post-vaccination)
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.
Measured: Day 30 (post-vaccination)
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Measured: Day 0 (pre-vaccination)
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Measured: Day 30 (post-vaccination)
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Measured: Day 0 (pre-vaccination)
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Measured: Day 30 (post-vaccination)
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers <1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.
Measured: Day 30 (post-vaccination)
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
Measured: Day 0 (pre-vaccination)
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
Measured: Day 30 (post-vaccination)
Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.
Measured: Within 30 minutes after vaccination
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.
Measured: Within 7 days after vaccination
Number of Participants With Unsolicited Adverse Events After Vaccination
An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE.
Measured: Within 30 days after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 201217 Jan 2013

First posted26 Nov 2012 (estimated)
Study start12 Nov 2012
Primary completion17 Jan 2013
Study completion17 Jan 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MeningitisStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 301 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01732627
Sponsor's protocol ID: MET44
Other IDs: U1111-1127-6804
Status last verified: Mar 2022
First submitted: 13 Nov 2012
Last updated: 4 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

Kirstein J, Pina M, Pan J, Jordanov E, Dhingra MS. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized study. Hum Vaccin Immunother. 2020 Jun 2;16(6):1299-1305. doi: 10.1080/21645515.2020.1733868. Epub 2020 Apr 1.
PubMed 32233961

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Meningitis trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Subjects 56 Years of Age and Older
ClinicalTrials.gov ID: NCT01732627
Acronym / sponsor ID: MET44
Conditions: Meningitis, Meningococcal Meningitis, Meningococcal Infections, Invasive Meningococcal Disease
Keywords: Meningitis, Meningococcal Meningitis, Menactra®, Menomune® A/C/Y/W 135
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 301 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: 12 Nov 2012 (actual)
Primary completion: 17 Jan 2013 (actual)
Study completion: 17 Jan 2013 (actual)
First posted: 26 Nov 2012 (estimated)
Results: Posted 9 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary objectives:

To describe the antibody responses to meningococcal serogroups A, C, Y, and W 135, measured by serum bactericidal assay using human complement (hSBA) and baby rabbit complement (rSBA), induced by a single dose of Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein (MenACYW) Conjugate vaccine or Menomune® - A/C/Y/W 135.
To describe the safety profile of a single dose of MenACYW Conjugate vaccine or Menomune® - A/C/Y/W 135.

Detailed description

All participants received a single dose of their assigned vaccine on Day 0. They were assessed for immunogenicity on Day 0 and Day 30, and monitored for safety throughout the study.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1: MenACYW Conjugate Vaccine	Experimental	Biological: Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate VaccineAdult participants aged greater than or equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W 135) Tetanus Toxoid (MenACYW) Conjugate vaccine on Day 0.
Group 2: Menomune® A/C/Y/W 135 vaccine	Active comparator	Biological: Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 CombinedAdult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W 135 Combined (Menomune®) vaccine on Day 0.

Who may qualify

Ages: 56 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Aged 56 or older on the day of inclusion.
Informed consent form had been signed and dated.
Able to attend all scheduled visits and complied with all trial procedures.

Key exclusion criteria (19 listed)

Participant was pregnant, or lactating, or of childbearing potential (were considered of non-childbearing potential, a female must be post-menopausal for at least 1 year, surgically sterile, or used an effective method of contraception or abstinence from at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination).
Participation at the time of study enrollment (or 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 preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination except for influenza vaccination, which might be received at least 2 weeks before or after the study vaccines.
Previous vaccination against meningococcal disease with either a trial vaccine or another vaccine.
Receipt of immune globulins, blood or blood-derived products in the past 3 months.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate VaccineAlso: MenACYW Conjugate Vaccine0.5 milliliter (mL), Intramuscular (IM)	Biological	Group 1: MenACYW Conjugate Vaccine
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 CombinedAlso: Menomune® A/C/Y/W 1350.5 mL, Subcutaneous (SC)	Biological	Group 2: Menomune® A/C/Y/W 135 vaccine

Primary outcome

Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Time frame: Day 0 (pre-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Time frame: Day 30 (post-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Time frame: Day 30 (post-vaccination)
Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by hSBA assay method. Seroresponse was defined as post-vaccination hSBA titers ≥1:8 for participants with pre-vaccination hSBA titers less than (<) 1:8, or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers ≥1:8.
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Time frame: Day 0 (pre-vaccination)
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Time frame: Day 30 (post-vaccination)
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 were measured by hSBA assay method.
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune®
Time frame: Day 0 (pre-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Percentage of Participants With Antibody Titers ≥1:8 and ≥1:128 Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune®
Time frame: Day 30 (post-vaccination)
Antibody titers against meningococcal serogroups A, C, Y, and W 135 were measured by rSBA assay method.
Percentage of Participants With Vaccine Seroresponse Measured by rSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Time frame: Day 30 (post-vaccination)
Vaccine seroresponse for serogroups A, C, Y, and W 135 was measured by rSBA assay method. Seroresponse was defined as post-vaccination rSBA titers ≥1:8 for participants with pre-vaccination rSBA titers <1:8, or at least a 4-fold increase in rSBA titers from pre- to post-vaccination for participants with pre-vaccination rSBA titers ≥1:8.
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Time frame: Day 0 (pre-vaccination)
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by rSBA Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine
Time frame: Day 30 (post-vaccination)
GMTs of antibodies against meningococcal serogroups A, C, Y, and W 135 antibody titers were measured by rSBA assay method.
Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination
Time frame: Within 30 minutes after vaccination
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report form (CRF) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event (SAE) was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRF.
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
Time frame: Within 7 days after vaccination
A solicited reaction (SR) was an adverse reaction (AR) observed and reported under the conditions (symptom and onset) prelisted in the CRF. Solicited injection site reactions included: pain, erythema, and swelling. Solicited systemic reactions included: fever, headache, malaise and, myalgia.
Number of Participants With Unsolicited Adverse Events After Vaccination
Time frame: Within 30 days after vaccination
An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRF in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. Non-serious AE (AE excluding SAE) which was significant and prevented daily activity was considered as Grade 3 unsolicited non-serious AE.

Results and safety

Results posted to the registry on 9 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: MenACYW Conjugate Vaccine	201	200
Group 2: Menomune® A/C/Y/W 135 Vaccine	100	100

Primary outcome: Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine

Time frame: Day 0 (pre-vaccination). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 1: MenACYW Conjugate Vaccine n = 195	Group 2: Menomune® A/C/Y/W 135 Vaccine n = 94
Serogroup A: ≥1:4	95.9 (92.1 to 98.2)	96.8 (91.0 to 99.3)
Serogroup A: ≥1:8	76.4 (69.8 to 82.2)	79.8 (70.2 to 87.4)
Serogroup C: ≥1:4	27.7 (21.5 to 34.5)	30.9 (21.7 to 41.2)
Serogroup C: ≥1:8	17.4 (12.4 to 23.5)	10.6 (5.2 to 18.7)
Serogroup Y: ≥1:4	22.1 (16.4 to 28.5)	26.6 (18.0 to 36.7)
Serogroup Y: ≥1:8	13.3 (8.9 to 18.9)	24.5 (16.2 to 34.4)
Serogroup W 135: ≥1:4	26.2 (20.1 to 32.9)	26.6 (18.0 to 36.7)
Serogroup W 135: ≥1:8	13.3 (8.9 to 18.9)	8.5 (3.7 to 16.1)

Population analysed: Analysis was performed on Per-Protocol Analysis Set (PPAS) population which included participants who received at least one dose of the study vaccine, had any valid serology result, and no protocol deviations.

Primary outcome: Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine

Time frame: Day 30 (post-vaccination). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 1: MenACYW Conjugate Vaccine n = 195	Group 2: Menomune® A/C/Y/W 135 Vaccine n = 94
Serogroup A: ≥1:4	97.4 (94.1 to 99.2)	93.6 (86.6 to 97.6)
Serogroup A: ≥1:8	93.8 (89.5 to 96.8)	85.1 (76.3 to 91.6)
Serogroup C: ≥1:4	85.6 (79.9 to 90.2)	79.8 (70.2 to 87.4)
Serogroup C: ≥1:8	74.9 (68.2 to 80.8)	62.8 (52.2 to 72.5)
Serogroup Y: ≥1:4	87.2 (81.7 to 91.5)	73.4 (63.3 to 82.0)
Serogroup Y: ≥1:8	80.5 (74.2 to 85.8)	59.6 (49.0 to 69.6)
Serogroup W 135: ≥1:4	88.7 (83.4 to 92.8)	77.7 (67.9 to 85.6)
Serogroup W 135: ≥1:8	79.5 (73.1 to 84.9)	60.6 (50.0 to 70.6)

Population analysed: Analysis was performed on PPAS population.

Primary outcome: Percentage of Participants With Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W 135 Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine

Time frame: Day 30 (post-vaccination). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Group 1: MenACYW Conjugate Vaccine n = 195	Group 2: Menomune® A/C/Y/W 135 Vaccine n = 94
Serogroup A	65.1 (58.0 to 71.8)	46.8 (36.4 to 57.4)
Serogroup C	70.8 (63.8 to 77.0)	59.6 (49.0 to 69.6)
Serogroup Y	75.4 (68.7 to 81.3)	48.9 (38.5 to 59.5)
Serogroup W 135	74.4 (67.6 to 80.3)	55.3 (44.7 to 65.6)

Population analysed: Analysis was performed on PPAS population.

Primary outcome: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W 135 Measured by hSBA Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine

Time frame: Day 0 (pre-vaccination). Geometric mean (95% Confidence Interval). Unit: titers (1/dilution)

Measure	Group 1: MenACYW Conjugate Vaccine n = 195	Group 2: Menomune® A/C/Y/W 135 Vaccine n = 94
Serogroup A	9.73 (8.65 to 10.9)	10.4 (8.58 to 12.5)
Serogroup C	3.32 (2.87 to 3.85)	2.87 (2.49 to 3.31)
Serogroup Y	3.02 (2.63 to 3.47)	3.53 (2.84 to 4.38)
Serogroup W 135	2.83 (2.56 to 3.14)	2.83 (2.40 to 3.33)

Population analysed: Analysis was performed on PPAS population.

Adverse events

Time frame: Unsolicited AE data were collected from Day 0 up to Day 30 post-vaccination. The SRs were collected within 7 days post-vaccination. SAE information was collected throughout the trial (up to 30 days post-vaccination).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: MenACYW Conjugate Vaccine	0 of 199 (0%)	114 of 199 (57.3%)	0 of 199
Group 2: Menomune® A/C/Y/W 135 Vaccine	0 of 100 (0%)	54 of 100 (54%)	0 of 100

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 32233961Kirstein J, Pina M, Pan J, Jordanov E, Dhingra MS. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized study. Hum Vaccin Immunother. 2020 Jun 2;16(6):1299-1305. doi: 10.1080/21645515.2020.1733868. Epub 2020 Apr 1.
Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Sanofi Pasteur Inc.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Antibody Titers ≥1:4 and ≥1:8 Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W 135 Before Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine (time frame: Day 0 (pre-vaccination)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01732627, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.