Clinical trial NCT03077438: Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years
Official title: Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children 2 to 9 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis
Meningococcal Meningitis
Meningococcal Infections
Keywords: Meningitis
Meningococcal Meningitis
MenACYW Conjugate vaccine
MENVEO®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-03-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study was to evaluate the immunogenicity and describe the safety of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine compared to the licensed Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) vaccine in children 2 to 9 years of age in the United States (US) and Puerto Rico.

Primary objective:

- To demonstrate the non-inferiority of the vaccine seroresponse to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine compared to that observed following the administration of a single dose of MENVEO® in children aged 2 to 9 years.

Secondary objectives:

* To compare the serum bactericidal assay using human complement (hSBA) antibody geometric mean titers (GMTs) of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of MENVEO® in children 2 to 9 years of age.
* To evaluate the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine and those observed following the administration of MENVEO® in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively.
* To evaluate the hSBA vaccine seroresponse to meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) post-vaccination in children 2 to 5 years of age, and in children 6 to 9 years of age, respectively.

Observational objective:

- To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed MENVEO®.

Detailed description: Healthy children were randomized and received a single dose of either MenACYW Conjugate vaccine or MENVEO®. They were assessed for immunogenicity at baseline (pre-vaccination) and at 30-44 days post-vaccination. Safety information were collected post-vaccination and throughout the entire study.

Eligibility criteria: Inclusion Criteria:

* Aged 2 to 9 years on the day of inclusion.
* Assent form had been signed and dated by the participant (as required by local regulations) and informed consent form had been signed and dated by parent(s) or guardian.
* Participant and parent/guardian were able to attend all scheduled visits and complied with all trial procedures.

Exclusion Criteria:

* Participant was 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 until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche.
* 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 prior to Visit 2 except for influenza vaccination, which might be received at least 2 weeks before or after the study investigational vaccines. This exception included monovalent, multivalent, live, and attenuated influenza vaccines.
* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (ie., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, Y, W; or meningococcal B serogroup containing 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 traveling 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 vaccines used in the trial or to a vaccine containing any of the same substances.
* Verbal report of thrombocytopenia, contraindicating intramuscular vaccination by the Investigator's judgment.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion.
* Personal history of Guillain-Barré syndrome.
* Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine.
* 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's judgment) on the day of vaccination or febrile illness (temperature ≥100.4°F). 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 72 hours prior to the first blood draw.
* Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.

Primary outcomes:
measure: Percentage of Participants Achieving Seroresponse Measured by Serum Bactericidal Assay Using Human Complement (hSBA) Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine
timeFrame: Day 30 (post-vaccination)
Secondary outcomes:
measure: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 9 Years of Age
timeFrame: Day 30 (post-vaccination)
measure: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
timeFrame: Day 30 (post-vaccination)
measure: Geometric Mean Titers of Antibodies Against Meningococcal Serogroups A, C, Y, and W Measured by hSBA Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years of Age
timeFrame: Day 30 (post-vaccination)
measure: Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 2 to 5 Years of Age
timeFrame: Day 30 (post-vaccination)
measure: Percentage of Participants Achieving Vaccine Seroresponse Measured by hSBA Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or MENVEO® Vaccine in Children 6 to 9 Years Age
timeFrame: Day 30 (post-vaccination)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site
state: Alabama
city: Dothan
country: United States
facility: Investigational Site
state: Alabama
city: Tucson
country: United States
facility: Investigational Site
state: Arizona
city: Jonesboro
country: United States
facility: Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Investigational Site
state: California
city: Downey
country: United States
facility: Investigational Site
state: California
city: Paramount
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investigational Site
state: California
city: Council Bluffs
country: United States
facility: Investigational Site
state: Iowa
city: Bardstown
country: United States
facility: Investigational Site
state: Kentucky
city: Nicholasville
country: United States
facility: Investigational Site
state: Kentucky
city: Metairie
country: United States
facility: Investigational Site
state: Louisiana
city: Woburn
country: United States
facility: Investigational Site
state: Massachusetts
city: Bridgeton
country: United States
facility: Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Investigational Site
state: Nebraska
city: Cincinnati
country: United States
facility: Investigational Site
state: Ohio
city: Cleveland
country: United States
facility: Investigational Site
state: Ohio
city: Dayton
country: United States
facility: Investigational Site
state: Ohio
city: Fairfield
country: United States
facility: Investigational Site
state: Ohio
city: Grants Pass
country: United States
facility: Investigational Site
state: Oregon
city: Gresham
country: United States
facility: Investigational Site
state: Oregon
city: Erie
country: United States
facility: Investigational Site
state: Pennsylvania
city: Hermitage
country: United States
facility: Investigational Site
state: Pennsylvania
city: Goodlettsville
country: United States
facility: Investigational Site
state: Tennessee
city: Tullahoma
country: United States
facility: Investigational Site
state: Tennessee
city: Layton
country: United States
facility: Investigational Site
state: Utah
city: Orem
country: United States
facility: Investigational Site
state: Utah
city: Roy
country: United States
facility: Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site
state: Utah
city: Salt Lake City
country: United States
facility: Investigational Site
state: Utah
city: South Jordan
country: United States
facility: Investigational Site
state: Utah
city: Syracuse
country: United States
facility: Investigational Site
state: Utah
city: West Jordan
country: United States
facility: Investigational Site
state: Utah
city: Midlothian
country: United States
facility: Investigational Site
state: Virginia
city: San Juan
country: Puerto Rico
facility: Investigational Site
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Officer, MD
role: STUDY_DIRECTOR
References:
citation: Baccarini CI, Simon MW, Brandon D, Christensen S, Jordanov E, Dhingra MS. Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Meningococcal-Naive Children 2-9 Years of Age: A Phase III, Randomized Study. Pediatr Infect Dis J. 2020 Oct;39(10):955-960. doi: 10.1097/INF.0000000000002832.