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

Phase 3

Completed

Conditions: Meningococcal Infection (Healthy Volunteers)

Interventions: Biological: Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
Other: Blood sample

Registration Number: NCT04142242

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary: Primary Objective:

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.

Detailed Description: Study duration per participant in Group 1 and Group 2 was approximately 30 days including: 1 day of screening and vaccination, 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 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 471

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2: MenACYW Conjugate Vaccine (MET49 - MenACYW Conjugate Vaccine-primed Participants)	Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine	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).
Group 6: MenACYW Conjugate Vaccine-primed Participants (MET44)	Blood sample	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).
Group 1: MenACYW Conjugate Vaccine (MET 49 - Menomune-primed Participants)	Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine	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).
Group 3: MenACYW Conjugate Vaccine (MET49: Menomune-primed Participants)	Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine	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).
Group 5: Menomune-primed Participants (MET44)	Blood sample	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).
Group 4: MenACYW Conjugate Vaccine (MET49: MenACYW-primed Participants)	Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine	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).

Primary Outcome Measures

Name	Time	Method
Stage I: Percentage of Participants With Seroresponse for Meningococcal Serogroups A, C, W & Y Measured by Serum Bactericidal Assay Using Human Complement (hSBA) After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 1 (Menomune-primed)	Day 30 (post-vaccination) in study MEQ00066	Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.

Secondary Outcome Measures

Name	Time	Method
Stage II: Percentage of Participants With Antibody Titers >=1:8 and >=1:128 Against Meningococcal Serogroups A, C, Y, and W Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4	5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49	Antibody titers against meningococcal serogroups A, C, W, and Y were measured by rSBA.
Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4	5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49	GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution.
Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Group 2 (MenACYW Conjugate Vaccine-primed Participants)	Day 30 (post-vaccination) in study MEQ00066	Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
Stage I: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 1 to 6	Day 0 (pre-vaccination) in study MEQ00066	Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA.
Stage I: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA Before and After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066 (Groups 1 to 4)	Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MEQ00066	GMTs of antibodies against meningococcal serogroups A, C, W, and Y 135 were measured by hSBA. Titers are expressed in terms of 1/dilution. At Baseline, Group 1 was equivalent to Group 3 (both groups were Menomune-primed in MET49) and Group 2 was equivalent to Group 4 (both groups were MenACYW Conjugate Vaccine-primed in MET49), therefore it was planned to collect and present pooled data of Groups 1 and 3 and Groups 2 and 4 for Day 0 (pre-vaccination) in this outcome measure. Here, "0" in the number analyzed field for Day 30 signifies that data were not planned to be collected and analyzed for Groups 3 and 4 participants as pre-specified in the protocol.
Stage I: Percentage of Participants With Vaccine Seroresponse for Meningococcal Serogroups A, C, W, and Y Measured by hSBA at Day 6 After Vaccination With MenACYW Conjugate Vaccine in Study MEQ00066: Groups 1 and 2	Day 6 (post-vaccination) in study MEQ00066	Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>= 1:16 for participants with pre-vaccination hSBA titer \< 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8.
Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6	Day 0 (pre-vaccination in MEQ00066)	GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by hSBA. Titers were expressed in terms of 1/dilution.
Stage II: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by rSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4	5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49	GMTs of antibodies against meningococcal serogroups A, C, W, and Y were measured by rSBA. Titers were expressed in terms of 1/dilution.
Stage II: Percentage of Participants With Antibody Titers >=1:4 and >=1:8 Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA After Primary Vaccination With Menomune Vaccine or MenACYW Conjugate Vaccine: Groups 3 and 4	5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49	Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA.

Trial Locations

Locations (34): Investigational Site Number 8400021
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Greensboro, North Carolina, United States
Investigational Site Number 8400024
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Dallas, Texas, United States
Investigational Site Number 8400038
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Clearwater, Florida, United States
Investigational Site Number 8400027
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Newton, Kansas, United States
Investigational Site Number 8400030
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Saint Louis, Missouri, United States
Investigational Site Number 8400012
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Raleigh, North Carolina, United States
Investigational Site Number 8400033
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Winston-Salem, North Carolina, United States
Investigational Site Number 8400017
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Wichita, Kansas, United States
Investigational Site Number 8400003
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San Diego, California, United States
Investigational Site Number 8400035
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Cincinnati, Ohio, United States
Investigational Site Number 8400005
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Cincinnati, Ohio, United States
Investigational Site Number 8400011
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Columbus, Ohio, United States
Investigational Site Number 8400002
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Salt Lake City, Utah, United States
Investigational Site Number 8400026
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Chandler, Arizona, United States
Investigational Site Number 8400028
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Waterbury, Connecticut, United States
Investigational Site Number 8400022
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Ponte Vedra, Florida, United States
Investigational Site Number 8400032
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Port Orange, Florida, United States
Investigational Site Number 8400020
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West Palm Beach, Florida, United States
Investigational Site Number 8400007
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Jacksonville, Florida, United States
Investigational Site Number 8400023
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DeLand, Florida, United States
Investigational Site Number 8400015
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Jacksonville, Florida, United States
Investigational Site Number 8400016
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Metairie, Louisiana, United States
Investigational Site Number 8400010
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Elkridge, Maryland, United States
Investigational Site Number 8400031
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Richfield, Minnesota, United States
Investigational Site Number 8400019
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Endwell, New York, United States
Investigational Site Number 8400013
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Fargo, North Dakota, United States
Investigational Site Number 8400014
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Uniontown, Pennsylvania, United States
Investigational Site Number 8400034
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Mount Pleasant, South Carolina, United States
Investigational Site Number 8400018
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Anderson, South Carolina, United States
Investigational Site Number 8400036
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Mount Pleasant, South Carolina, United States
Investigational Site Number 8400001
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Murray, Utah, United States
Investigational Site Number 8400025
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West Jordan, Utah, United States
Investigational Site Number 8400004
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Charlottesville, Virginia, United States
Investigational Site Number 6300001
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San Juan, Puerto Rico