Clinical trial NCT04142242: 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
Official title: Safety and Immunogenicity of a Single Dose of MenACYW Conjugate Vaccine at Least 3 Years Following Initial Vaccination With Either Menomune® Vaccine or MenACYW Conjugate Vaccine in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Infection (Healthy Volunteers)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2019-10-29
Enrollment: 471
Sex: ALL
Minimum age (years): 59
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: Day 30 (post-vaccination) in study MEQ00066
Secondary outcomes:
measure: 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)
timeFrame: Day 30 (post-vaccination) in study MEQ00066
measure: 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
timeFrame: Day 6 (post-vaccination) in study MEQ00066
measure: 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)
timeFrame: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MEQ00066
measure: Stage I: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, W, and Y Measured by hSBA: Groups 5 and 6
timeFrame: Day 0 (pre-vaccination in MEQ00066)
measure: 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
timeFrame: Day 0 (pre-vaccination) in study MEQ00066
measure: 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
timeFrame: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49
measure: 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
timeFrame: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49
measure: 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
timeFrame: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49
measure: 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
timeFrame: 5 years post primary vaccination (with Menomune or MenACYW Conjugate vaccine) in study MET49
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Investigational Site Number 8400026
state: Arizona
city: San Diego
country: United States
facility: Investigational Site Number 8400003
state: California
city: Waterbury
country: United States
facility: Investigational Site Number 8400028
state: Connecticut
city: Clearwater
country: United States
facility: Investigational Site Number 8400038
state: Florida
city: DeLand
country: United States
facility: Investigational Site Number 8400023
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 8400007
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 8400015
state: Florida
city: Ponte Vedra
country: United States
facility: Investigational Site Number 8400022
state: Florida
city: Port Orange
country: United States
facility: Investigational Site Number 8400032
state: Florida
city: West Palm Beach
country: United States
facility: Investigational Site Number 8400020
state: Florida
city: Newton
country: United States
facility: Investigational Site Number 8400027
state: Kansas
city: Wichita
country: United States
facility: Investigational Site Number 8400017
state: Kansas
city: Metairie
country: United States
facility: Investigational Site Number 8400016
state: Louisiana
city: Elkridge
country: United States
facility: Investigational Site Number 8400010
state: Maryland
city: Richfield
country: United States
facility: Investigational Site Number 8400031
state: Minnesota
city: Saint Louis
country: United States
facility: Investigational Site Number 8400030
state: Missouri
city: Endwell
country: United States
facility: Investigational Site Number 8400019
state: New York
city: Greensboro
country: United States
facility: Investigational Site Number 8400021
state: North Carolina
city: Raleigh
country: United States
facility: Investigational Site Number 8400012
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigational Site Number 8400033
state: North Carolina
city: Fargo
country: United States
facility: Investigational Site Number 8400013
state: North Dakota
city: Cincinnati
country: United States
facility: Investigational Site Number 8400035
state: Ohio
city: Cincinnati
country: United States
facility: Investigational Site Number 8400005
state: Ohio
city: Columbus
country: United States
facility: Investigational Site Number 8400011
state: Ohio
city: Uniontown
country: United States
facility: Investigational Site Number 8400014
state: Pennsylvania
city: Anderson
country: United States
facility: Investigational Site Number 8400018
state: South Carolina
city: Mount Pleasant
country: United States
facility: Investigational Site Number 8400034
state: South Carolina
city: Mount Pleasant
country: United States
facility: Investigational Site Number 8400036
state: South Carolina
city: Dallas
country: United States
facility: Investigational Site Number 8400024
state: Texas
city: Murray
country: United States
facility: Investigational Site Number 8400001
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site Number 8400002
state: Utah
city: West Jordan
country: United States
facility: Investigational Site Number 8400025
state: Utah
city: Charlottesville
country: United States
facility: Investigational Site Number 8400004
state: Virginia
city: San Juan
country: Puerto Rico
facility: Investigational Site Number 6300001
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: