Trial Outcomes & Findings for Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older (NCT NCT02842866)

Last Updated: 2022-04-05

Results Overview

Vaccine seroresponse for serogroups A, C, Y, and W was measured by serum bactericidal assay using human complement (hSBA). It was defined as post-vaccination hSBA titers ≥1:16 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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

907 participants

Primary outcome timeframe

Day 30 (Post-vaccination)

Results posted on

2022-04-05

Participant Flow

Study was conducted from 15-July-2016 to 13-February-2017 at 35 sites in the United States and Puerto Rico.

Total 907 participants were enrolled in the study, out of which 906 were randomized. 1 participant was not randomized to either of the 2 treatment groups; this participant was not vaccinated and did not provide blood samples, therefore not counted in any analysis.

Participant milestones

Participant milestones
Measure	Group 1: MenACYW Conjugate Vaccine Healthy, adult participants aged greater than equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine on Day 0.	Group 2: Menomune® Vaccine Healthy, adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Serogroups A, C, Y, and W-135 Combined (Menomune®) Vaccine on Day 0.
Overall Study STARTED	451	455
Overall Study Vaccinated	448	453
Overall Study COMPLETED	444	452
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: MenACYW Conjugate Vaccine Healthy, adult participants aged greater than equal to (≥) 56 years received a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine on Day 0.	Group 2: Menomune® Vaccine Healthy, adult participants aged ≥56 years received a single dose of Meningococcal Polysaccharide Serogroups A, C, Y, and W-135 Combined (Menomune®) Vaccine on Day 0.
Overall Study Serious Adverse Event	0	1
Overall Study Protocol Violation	4	2
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adults 56 Years and Older

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: MenACYW Conjugate Vaccine n=451 Participants Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate vaccine on Day 0.	Group 2: Menomune® Vaccine n=455 Participants Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.	Total n=906 Participants Total of all reporting groups
Age, Continuous	66.9 years STANDARD_DEVIATION 7.51 • n=5 Participants	67.3 years STANDARD_DEVIATION 7.53 • n=7 Participants	67.1 years STANDARD_DEVIATION 7.52 • n=5 Participants
Sex: Female, Male Female	259 Participants n=5 Participants	261 Participants n=7 Participants	520 Participants n=5 Participants
Sex: Female, Male Male	192 Participants n=5 Participants	194 Participants n=7 Participants	386 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	54 Participants n=5 Participants	47 Participants n=7 Participants	101 Participants n=5 Participants
Race (NIH/OMB) White	389 Participants n=5 Participants	404 Participants n=7 Participants	793 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 30 (Post-vaccination)

Population: Analysis was performed on per protocol analysis set which included all participants who received at least one dose of the study vaccine, had a valid post-vaccination serology result and had no protocol deviations.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=433 Participants Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate Vaccine on Day 0.	Group 2: Menomune® Vaccine n=431 Participants Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.
Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menomune® Vaccine Serogroup A	58.2 percentage of participants Interval 53.4 to 62.9	42.5 percentage of participants Interval 37.7 to 47.3
Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menomune® Vaccine Serogroup C	77.1 percentage of participants Interval 72.9 to 81.0	49.7 percentage of participants Interval 44.8 to 54.5
Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menomune® Vaccine Serogroup Y	74.4 percentage of participants Interval 70.0 to 78.4	43.4 percentage of participants Interval 38.7 to 48.2
Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menomune® Vaccine Serogroup W	62.6 percentage of participants Interval 57.8 to 67.2	44.8 percentage of participants Interval 40.0 to 49.6

SECONDARY outcome

Timeframe: Day 30 (Post-vaccination)

Population: Analysis was performed on per-protocol analysis set.

GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA method.

Outcome measures

Outcome measures
Measure	Group 1: MenACYW Conjugate Vaccine n=433 Participants Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate Vaccine on Day 0.	Group 2: Menomune® Vaccine n=431 Participants Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine Serogroup Y	69.1 titers (1/dilutions) Interval 58.7 to 81.4	21.0 titers (1/dilutions) Interval 17.4 to 25.3
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine Serogroup A	55.1 titers (1/dilutions) Interval 46.8 to 65.0	31.4 titers (1/dilutions) Interval 26.9 to 36.7
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine Serogroup C	101 titers (1/dilutions) Interval 83.8 to 123.0	24.7 titers (1/dilutions) Interval 20.7 to 29.5
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine or Menomune® Vaccine Serogroup W	28.1 titers (1/dilutions) Interval 23.7 to 33.3	15.5 titers (1/dilutions) Interval 13.0 to 18.4

Adverse Events

Group 1: MenACYW Conjugate Vaccine

Serious events: 15 serious events

Other events: 182 other events

Deaths: 0 deaths

Group 2: Menomune® Vaccine

Serious events: 15 serious events

Other events: 121 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: MenACYW Conjugate Vaccine n=448 participants at risk Healthy, adult participants aged ≥56 years received a single dose of MenACYW Conjugate Vaccine on Day 0.	Group 2: Menomune® Vaccine n=453 participants at risk Healthy, adult participants aged ≥56 years received a single dose of Menomune®- A/C/Y/W-135 Vaccine on Day 0.
General disorders Injection Site Erythema	5.1% 23/448 • Number of events 23 • Unsolicited non-serious adverse events (AEs) were collected from Day 0 to Day 30 post-vaccination and solicited reactions (SR) were collected within 7 days post-vaccination. Serious Adverse Events were collected throughout the trial (up to 180 days post-vaccination). An SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set which included participants who had received at least 1 dose of the study vaccine and have any safety data available.	0.00% 0/453 • Unsolicited non-serious adverse events (AEs) were collected from Day 0 to Day 30 post-vaccination and solicited reactions (SR) were collected within 7 days post-vaccination. Serious Adverse Events were collected throughout the trial (up to 180 days post-vaccination). An SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set which included participants who had received at least 1 dose of the study vaccine and have any safety data available.
General disorders Injection Site Pain	25.2% 113/448 • Number of events 113 • Unsolicited non-serious adverse events (AEs) were collected from Day 0 to Day 30 post-vaccination and solicited reactions (SR) were collected within 7 days post-vaccination. Serious Adverse Events were collected throughout the trial (up to 180 days post-vaccination). An SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set which included participants who had received at least 1 dose of the study vaccine and have any safety data available.	9.5% 43/453 • Number of events 43 • Unsolicited non-serious adverse events (AEs) were collected from Day 0 to Day 30 post-vaccination and solicited reactions (SR) were collected within 7 days post-vaccination. Serious Adverse Events were collected throughout the trial (up to 180 days post-vaccination). An SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set which included participants who had received at least 1 dose of the study vaccine and have any safety data available.
General disorders Malaise	14.5% 65/448 • Number of events 66 • Unsolicited non-serious adverse events (AEs) were collected from Day 0 to Day 30 post-vaccination and solicited reactions (SR) were collected within 7 days post-vaccination. Serious Adverse Events were collected throughout the trial (up to 180 days post-vaccination). An SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set which included participants who had received at least 1 dose of the study vaccine and have any safety data available.	11.3% 51/453 • Number of events 51 • Unsolicited non-serious adverse events (AEs) were collected from Day 0 to Day 30 post-vaccination and solicited reactions (SR) were collected within 7 days post-vaccination. Serious Adverse Events were collected throughout the trial (up to 180 days post-vaccination). An SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set which included participants who had received at least 1 dose of the study vaccine and have any safety data available.
Musculoskeletal and connective tissue disorders Myalgia	21.9% 98/448 • Number of events 100 • Unsolicited non-serious adverse events (AEs) were collected from Day 0 to Day 30 post-vaccination and solicited reactions (SR) were collected within 7 days post-vaccination. Serious Adverse Events were collected throughout the trial (up to 180 days post-vaccination). An SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set which included participants who had received at least 1 dose of the study vaccine and have any safety data available.	15.2% 69/453 • Number of events 69 • Unsolicited non-serious adverse events (AEs) were collected from Day 0 to Day 30 post-vaccination and solicited reactions (SR) were collected within 7 days post-vaccination. Serious Adverse Events were collected throughout the trial (up to 180 days post-vaccination). An SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set which included participants who had received at least 1 dose of the study vaccine and have any safety data available.
Nervous system disorders Headache	19.0% 85/448 • Number of events 85 • Unsolicited non-serious adverse events (AEs) were collected from Day 0 to Day 30 post-vaccination and solicited reactions (SR) were collected within 7 days post-vaccination. Serious Adverse Events were collected throughout the trial (up to 180 days post-vaccination). An SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set which included participants who had received at least 1 dose of the study vaccine and have any safety data available.	14.6% 66/453 • Number of events 66 • Unsolicited non-serious adverse events (AEs) were collected from Day 0 to Day 30 post-vaccination and solicited reactions (SR) were collected within 7 days post-vaccination. Serious Adverse Events were collected throughout the trial (up to 180 days post-vaccination). An SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the eCRF (i.e., solicited) in terms of symptom and/or onset post-vaccination. Analysis was performed on safety analysis set which included participants who had received at least 1 dose of the study vaccine and have any safety data available.

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 participant 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.
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