Trial Outcomes & Findings for Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) in Older Adults in Turkey and Lebanon (NCT NCT03869866)

Results Overview

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the rSBA. Seroprotection rate is defined as percentage of participants with rSBA titer \>=1.8 who received MenACYW conjugate vaccine. Percentages are rounded off to the tenth decimal place.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

290 participants

Primary outcome timeframe

Day 30 post-dose

Results posted on

2025-03-17

Participant Flow

The study was conducted at 3 centers in 2 countries between 08 April 2019 to 18 March 2022.

A total of 290 participants who met all the inclusion criteria were enrolled in the study.

Participant milestones

Participant milestones
Measure	MenACYW Conjugate Vaccine Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 milliliter (mL) intramuscular (IM) injection on Day 0.
Overall Study STARTED	290
Overall Study Vaccinated	288
Overall Study COMPLETED	286
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	MenACYW Conjugate Vaccine Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 milliliter (mL) intramuscular (IM) injection on Day 0.
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Study to Assess the Safety and Immunogenicity of a Single Dose of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) in Older Adults in Turkey and Lebanon

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MenACYW Conjugate Vaccine n=290 Participants Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0.
Age, Continuous	64.7 years STANDARD_DEVIATION 6.97 • n=5 Participants
Sex: Female, Male Female	102 Participants n=5 Participants
Sex: Female, Male Male	188 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	290 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30 post-dose

Population: The Full analysis set (FAS) consisted of participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. Only those participants with data collected are reported.

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the rSBA. Seroprotection rate is defined as percentage of participants with rSBA titer \>=1.8 who received MenACYW conjugate vaccine. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=287 Participants Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0.
Percentage of Participants With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, W, and Y Serogroup A	90.1 percentage of participants Interval 85.9 to 93.4
Percentage of Participants With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, W, and Y Serogroup C	94.1 percentage of participants Interval 90.7 to 96.5
Percentage of Participants With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, W, and Y Serogroup W	91.3 percentage of participants Interval 87.4 to 94.3
Percentage of Participants With Serum Bactericidal Assay Using Baby Rabbit Complement (rSBA) Antibody Titers Greater Than or Equal to (>=) 1:8 Against Meningococcal Serogroups A, C, W, and Y Serogroup Y	95.5 percentage of participants Interval 92.4 to 97.6

PRIMARY outcome

Timeframe: Day 30 post-dose

Population: The FAS consisted of participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. Only those participants with data collected are reported.

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the rSBA and the results were expressed as geometric mean titers.

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=287 Participants Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0.
Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA Serogroup Y	2539 Titer Interval 1970.0 to 3272.0
Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA Serogroup A	635 Titer Interval 477.0 to 845.0
Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA Serogroup C	2038 Titer Interval 1529.0 to 2718.0
Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA Serogroup W	2710 Titer Interval 1929.0 to 3807.0

PRIMARY outcome

Timeframe: Day 30 post-dose

Population: The FAS consisted of participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. Only those participants with data collected are reported.

Functional meningococcal antibody activity against serogroups A, C, W, and Y were measured in a serum bactericidal assay utilizing the hSBA and the results were expressed as geometric mean titers.

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=287 Participants Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0.
Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Serogroup A	31.9 Titer Interval 26.3 to 38.8
Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Serogroup C	135 Titer Interval 105.0 to 172.0
Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Serogroup W	56.3 Titer Interval 44.0 to 72.1
Geometric Mean Titers Against Meningococcal Serogroups A, C, W, and Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Serogroup Y	130 Titer Interval 102.0 to 165.0

PRIMARY outcome

Timeframe: Pre-dose Day 0 and Day 30 post-dose

Population: The FAS consisted of participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. Only those participants with data collected are reported.

Tetanus toxoid was contained in the investigational vaccine as a carrier protein. Anti-tetanus antibodies were measured by electrochemiluminescent (ECL) assay. The captured antibodies were then detected using a sulfotag-conjugated anti-human immunoglobulin (Ig)G conjugate.

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=287 Participants Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0.
Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid Day 0 (pre-dose)	0.040 International units/milliliter (IU/mL) Interval 0.033 to 0.049
Geometric Mean Concentrations (GMCs) of Antibodies Against Tetanus Toxoid Day 30 (post-dose)	0.429 International units/milliliter (IU/mL) Interval 0.291 to 0.631

PRIMARY outcome

Timeframe: Pre-dose Day 0 and Day 30 post-dose

Population: The FAS consisted of participants who received at least 1 dose of the study vaccine and had a valid post-vaccination serology result. Only those participants with data collected are reported.

Seroprotective levels defined as antibody titers \>= 0.01 IU/mL and \>= 0.1 IU/mL of antibody concentrations to tetanus toxoid. Tetanus toxoid was contained in the investigational vaccine as a carrier protein. Anti-tetanus antibodies were measured by ECL assay. The captured antibodies were then detected using a sulfotag-conjugated anti-human IgG conjugate. Percentages are rounded off to the tenth decimal place.

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=287 Participants Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0.
Percentage of Participants Who Achieved Seroprotective Levels Day 0 (pre-dose): >=0.01 IU/mL	87.8 percentage of participants Interval 83.4 to 91.3
Percentage of Participants Who Achieved Seroprotective Levels Day 0 (pre-dose): >=0.1 IU/mL	28.3 percentage of participants Interval 23.2 to 33.9
Percentage of Participants Who Achieved Seroprotective Levels Day 30 (post-dose): >=0.01 IU/mL	93.0 percentage of participants Interval 89.4 to 95.7
Percentage of Participants Who Achieved Seroprotective Levels Day 30 (post-dose): >=0.1 IU/mL	56.8 percentage of participants Interval 50.8 to 62.6

PRIMARY outcome

Timeframe: Within 30 minutes post-dose

Population: The Safety analysis set (SafAS) consisted of participants who had received at least 1 dose of the study vaccine and had any safety data available.

An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions \[i.e.pre-listed in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination\].

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=288 Participants Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0.
Number of Participants With Unsolicited Systemic Adverse Events (AEs)	0 Participants

PRIMARY outcome

Timeframe: Up to 7 days post-dose

Population: The SafAS consisted of participants who had received at least 1 dose of the study vaccine and had any safety data available. Only those participants with data collected are reported.

All noxious and unintended responses to a study vaccine related to any dose was considered adverse reactions (AR). A solicited reaction is an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB. An injection site reaction is an AR at and around the injection site. Injection site reactions are commonly inflammatory reactions. They were considered to be related to the study vaccine administered. Systemic reactions were all ARs that were not injection or administration site reactions and included systemic manifestations such as headache, fever, as well as localized or topical manifestations that are not associated with the vaccination or administration site.

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=287 Participants Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0.
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions Solicited injection site reaction	39 Participants
Number of Participants With Solicited Injection Site Reactions and Systemic Reactions Solicited systemic reaction	59 Participants

PRIMARY outcome

Timeframe: Up to Day 30 post-dose

Population: The SafAS consisted of participants who had received at least 1 dose of the study vaccine and had any safety data available.

An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study vaccine, whether or not considered related to the study vaccine. An unsolicited AE is an observed AE that does not fulfill the conditions of solicited reactions (i.e. pre-listed in the CRB in terms of diagnosis and/or onset window post-vaccination).

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=288 Participants Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0.
Number of Participants With Unsolicited Non-Serious Adverse Events	41 Participants

PRIMARY outcome

Timeframe: From Day 0 up to end of study, approximately 44 days

Population: The SafAS consisted of participants who had received at least 1 dose of the study vaccine and had any safety data available.

A SAEs is defined as any untoward medical occurrence, at any dose that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent disability/incapacity, was a congenital anomaly/birth defect, or other important medical event.

Outcome measures

Outcome measures
Measure	MenACYW Conjugate Vaccine n=288 Participants Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0.
Number of Participants With Serious Adverse Events (SAEs)	6 Participants

Adverse Events

MenACYW

Serious events: 6 serious events

Other events: 69 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	MenACYW n=288 participants at risk Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0.
Cardiac disorders Cardiac Arrest	0.35% 1/288 • Number of events 1 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.
Infections and infestations Covid-19	0.35% 1/288 • Number of events 1 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.
Infections and infestations Pneumonia	0.69% 2/288 • Number of events 2 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.
Infections and infestations Urinary Tract Infection	0.35% 1/288 • Number of events 1 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.
Metabolism and nutrition disorders Dehydration	0.35% 1/288 • Number of events 1 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.
Nervous system disorders Hypertensive Encephalopathy	0.35% 1/288 • Number of events 1 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.
Nervous system disorders Paraesthesia	0.35% 1/288 • Number of events 1 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.
Nervous system disorders Syncope	0.35% 1/288 • Number of events 1 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.
Renal and urinary disorders Acute Kidney Injury	0.35% 1/288 • Number of events 1 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.
Vascular disorders Hypotension	0.35% 1/288 • Number of events 1 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.

Other adverse events

Other adverse events
Measure	MenACYW n=288 participants at risk Participants received a single dose of meningococcal polysaccharide \[Serogroups A, C, W and Y (MenACYW conjugate vaccine)\] 0.5 mL IM injection on Day 0.
General disorders Injection Site Pain	13.9% 40/288 • Number of events 41 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.
General disorders Malaise	9.4% 27/288 • Number of events 27 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.
Musculoskeletal and connective tissue disorders Myalgia	13.2% 38/288 • Number of events 38 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.
Nervous system disorders Headache	16.7% 48/288 • Number of events 49 • AEs and SAEs were collected from Day 0 up to end of study, approximately 44 days. All-cause mortality (death) was collected from signing of the informed consent form to the end of safety follow-up, a maximum of 35 months. Analysis was performed on SafAS population.

Additional Information

Trial Transparency Team

Sanofi Pasteur

Phone: 800-633-1610

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Publication restrictions are in place

Restriction type: OTHER