Clinical trial NCT01732627: Study of a Quadrivalent Meningococcal Conjugate Vaccine in Subjects Aged 56 and Older
Official title: Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered in Subjects 56 Years of Age and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningitis
Meningococcal Meningitis
Meningococcal Infections
Invasive Meningococcal Disease
Keywords: Meningitis
Meningococcal Meningitis
Menactra®
Menomune® A/C/Y/W 135
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-11-26
Enrollment: 301
Sex: ALL
Minimum age (years): 56
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).
* 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.

Primary outcomes:
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
timeFrame: Day 0 (pre-vaccination)
measure: 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
timeFrame: Day 30 (post-vaccination)
measure: 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
timeFrame: Day 30 (post-vaccination)
measure: 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
timeFrame: Day 0 (pre-vaccination)
measure: 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
timeFrame: Day 30 (post-vaccination)
measure: 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®
timeFrame: Day 0 (pre-vaccination)
measure: 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®
timeFrame: Day 30 (post-vaccination)
measure: 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
timeFrame: Day 30 (post-vaccination)
measure: 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
timeFrame: Day 0 (pre-vaccination)
measure: 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
timeFrame: Day 30 (post-vaccination)
measure: Number of Participants With Immediate Unsolicited Adverse Events (AEs) After Vaccination
timeFrame: Within 30 minutes after vaccination
measure: Number of Participants With Solicited Injection Site Reactions and Systemic Reactions After Vaccination
timeFrame: Within 7 days after vaccination
measure: Number of Participants With Unsolicited Adverse Events After Vaccination
timeFrame: Within 30 days after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Denver
country: United States
state: Colorado
city: Milford
country: United States
state: Connecticut
city: Edina
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Columbus
country: United States
state: Ohio
city: Anderson
country: United States
state: South Carolina
city: Murray
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Charlottesville
country: United States
state: Virginia
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.