Clinical trial NCT02752906: Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
Official title: Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis
Meningococcal Meningitis
Meningococcal Infections
Keywords: Meningitis
Meningococcal Meningitis
Meningococcal Infections
MenACYW Conjugate vaccine
Licensed Meningococcal Conjugate Vaccine (MCV4)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-04-27
Enrollment: 810
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study was to describe the safety and antibody response to booster administration with Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in participants who received their first quadrivalent meningococcal Conjugate vaccine dose in the past 4-10 years.

Primary Objective:

* To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW Conjugate vaccine compared to those observed following the administration of a booster dose of Menactra® in participants who were first vaccinated with 1 dose of a quadrivalent meningococcal vaccine 4 to 10 years before the booster dose.

Secondary Objectives:

* To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after vaccination in a subset of 120 participants.
* To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination.

Observational Objectives:

* To describe the antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination.
* To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days after vaccination with MenACYW Conjugate vaccine or Menactra® measured by rabbit serum bactericidal assay (rSBA) in a subset of participants.
* To describe the safety profile of MenACYW Conjugate vaccine compared to that of a licensed Menactra® after booster vaccination.

Detailed description: Healthy adolescents and adults who had received 1 dose of a quadrivalent meningococcal Conjugate vaccine 4 to 10 years previously were randomized to receive either 1 dose of MenACYW Conjugate vaccine or licensed Menactra®. All participants underwent immunogenicity assessment at baseline (pre-vaccination) and post-vaccination and were also evaluated for safety up to Day 180 post-vaccination. In addition, a subset had an additional blood sample collected at 6 days post-vaccination for immunogenicity assessment.

Eligibility criteria: Inclusion Criteria:

* Aged \>= 15 years on the day of inclusion.
* Participant has documented record of having received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years prior to study vaccination.
* Participant aged 15 to \< 18 years: assent form signed and dated by the participant and informed consent form (ICF) signed and dated by the parent or guardian.
* Participant aged \>=18 years: ICF signed and dated by the participant.
* Participants aged 15 to \< 18 years: both the participant and parent / guardian were able to attend all scheduled visits and to comply with all trial procedures.
* Participants aged \>= 18 years: able to attend all scheduled visits and to comply with all trial procedures.

Exclusion Criteria:

* Participant was pregnant, lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).
* Participation 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 (28 days) preceding the trial vaccination or planned receipt of any vaccine before Day 30 visit except for influenza vaccination, which may be received at least 2 weeks before study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
* Previous vaccination against meningococcal disease with either an investigational or approved meningococcal B 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 (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(s) used in the trial or to a vaccine containing any of the same substances.
* Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
* Personal history of Guillain-Barré syndrome.
* Verbal report of thrombocytopenia, contraindicating intramuscular vaccination in the Investigator's opinion.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion.
* 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, is at a stage where it might interfere with trial conduct or completion.
* Moderate or severe acute illness/infection (according to the Investigator's judgment) on the day of vaccination or febrile illness (temperature \>= 100.4°Fahrenheit \[F\]). A prospective participant should not be included in the study 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.

Primary outcomes:
measure: Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
timeFrame: Day 30 (post-vaccination)
Secondary outcomes:
measure: Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 6 After Vaccination
timeFrame: Day 6 (post-vaccination)
measure: Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
timeFrame: Day 30 (post-vaccination)
measure: Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine
timeFrame: Within 7 days post-vaccination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 016
state: Alabama
city: Dothan
country: United States
facility: Investigational Site Number 032
state: Alabama
city: Mesa
country: United States
facility: Investigational Site Number 026
state: Arizona
city: Jonesboro
country: United States
facility: Investigational Site Number 022
state: Arkansas
city: Downey
country: United States
facility: Investigational Site Number 005
state: California
city: La Puente
country: United States
facility: Investigational Site Number 014
state: California
city: San Diego
country: United States
facility: Investigational Site Number 029
state: California
city: San Diego
country: United States
facility: Investigational Site Number 001
state: California
city: Bardstown
country: United States
facility: Investigational Site Number 013
state: Kentucky
city: Nicholasville
country: United States
facility: Investigational Site Number 027
state: Kentucky
city: Metairie
country: United States
facility: Investigational Site Number 015
state: Louisiana
city: Woburn
country: United States
facility: Investigational Site Number 018
state: Massachusetts
city: Troy
country: United States
facility: Investigational Site Number 010
state: Michigan
city: Kansas City
country: United States
facility: Investigational Site Number 008
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site Number 028
state: Missouri
city: Lincoln
country: United States
facility: Investigational Site Number 023
state: Nebraska
city: Omaha
country: United States
facility: Investigational Site Number 031
state: Nebraska
city: Rochester
country: United States
facility: Investigational Site Number 006
state: New York
city: Fargo
country: United States
facility: Investigational Site Number 012
state: North Dakota
city: Cincinnati
country: United States
facility: Investigational Site Number 019
state: Ohio
city: Fairfield
country: United States
facility: Investigational Site Number 011
state: Ohio
city: Huber Heights
country: United States
facility: Investigational Site Number 025
state: Ohio
city: Kettering
country: United States
facility: Investigational Site Number 021
state: Ohio
city: Erie
country: United States
facility: Investigational Site Number 009
state: Pennsylvania
city: Hermitage
country: United States
facility: Investigational Site Number 007
state: Pennsylvania
city: Tullahoma
country: United States
facility: Investigational Site Number 024
state: Tennessee
city: Salt Lake City
country: United States
facility: Investigational Site Number 020
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site Number 003
state: Utah
city: South Jordan
country: United States
facility: Investigational Site Number 017
state: Utah
city: San Juan
country: Puerto Rico
facility: Investigational Site Number 030
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Anez G, Hedrick J, Simon MW, Christensen S, Jeanfreau R, Yau E, Pan J, Jordanov E, Dhingra MS. Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study. Hum Vaccin Immunother. 2020 Jun 2;16(6):1292-1298. doi: 10.1080/21645515.2020.1733867. Epub 2020 Mar 25.