Clinical trial NCT02842853: Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
Official title: Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults Aged 10 to 55 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis
Meningococcal Meningitis
Meningococcal Infections
Keywords: Meningitis
Meningococcal Meningitis
Meningococcal Infections
MenACYW Conjugate vaccine
Licensed MCV4 vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2016-07-25
Enrollment: 3344
Sex: ALL
Minimum age (years): 10
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study was to evaluate immune lot consistency of Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine and the immune non-inferiority compared to the licensed vaccine Menactra®, and describe the safety and additional immunogenicity of these study vaccines in adolescents and adults 10 to 55 years of age in the United States (US).

Primary Objectives:

* To demonstrate the immune lot consistency of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine with respect to serum bactericidal assay using human complement (hSBA) geometric mean titers (GMTs).
* To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra®.

Secondary Objective:

* To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra® in the adult population (18 to 55 years old).
* To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of MenACYW Conjugate vaccine (pooled Lots 1 to 3) compared to those observed following the administration of a single dose of Menactra® in the adolescent population (10 to 17 years old).
* To compare the hSBA vaccine seroresponses of meningococcal serogroups A, C, Y, and W for each of 3 lots of MenACYW Conjugate vaccine 30 days (+14 days) after vaccination.
* To compare the hSBA antibody GMTs of meningococcal serogroups A, C, Y, and W following the administration of MenACYW Conjugate vaccine to those observed following the administration of Menactra®.

Observational Objectives:

* To describe the safety profile of MenACYW Conjugate vaccine and that of the licensed Menactra®.

Detailed description: Healthy meningococcal-vaccine naïve adolescents and adults were randomized and received a single dose of either MenACYW Conjugate vaccine from 1 of the 3 lots (Lot 1, Lot 2, or Lot 3) or Menactra®. They were assessed for immunogenicity at baseline (pre-vaccination) and at 30 to 44 days post-vaccination. Safety information were collected post-vaccination and throughout the entire study.

Eligibility criteria: Inclusion Criteria:

* Aged 10 to 55 years on the day of inclusion.
* Informed consent form was signed and dated by the participant (aged 18 to 55 years) or assent form was signed and dated by the participant and informed consent form was signed and dated by the parent(s) or guardian (for participants aged 10 to \< 18 years).
* Participant (\>= 18 years) or participant (10 to \< 18 years) and parent / guardian were able to attend all scheduled visits and comply with all trial procedures.

Exclusion Criteria:

* Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must have been 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 prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
* Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or 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 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, as reported by the participant or the participant's parent / guardian, 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.
* Personal history of Guillain-Barre syndrome.
* Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within 10 years of the proposed study 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 degree Fahrenheit \[°F\]). A prospective participant was not be included in the study until the condition was 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 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: Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, And W Antibodies Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
timeFrame: Day 30 (post-vaccination)
measure: Percentage of Participants Achieving hSBA Vaccine Seroresponse for 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 Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adults
timeFrame: Day 30 (post-vaccination)
measure: Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine in Adolescents
timeFrame: Day 30 (post-vaccination)
measure: Percentage of Participants Achieving hSBA Vaccine Seroresponse for Meningococcal Serogroups A, C, Y And W Following Vaccination With 3 Lots of MenACYW Conjugate Vaccine
timeFrame: Day 30 (post-vaccination)
measure: Geometric Mean Titers (GMTs) of Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With MenACYW Conjugate and Menactra®
timeFrame: Day 30 (post-vaccination)
Other outcomes:
Locations:
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city: Mobile
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city: Sacramento
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city: San Diego
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state: California
city: San Diego
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state: California
city: Santa Rosa
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state: California
city: West Covina
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state: Colorado
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city: Hialeah
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city: Miami
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city: Orlando
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city: Sarasota
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city: South Miami
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city: West Palm Beach
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state: Florida
city: Savannah
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state: Georgia
city: Meridian
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state: Idaho
city: Council Bluffs
country: United States
state: Iowa
city: Lenexa
country: United States
state: Kansas
city: Newton
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city: Park City
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state: Kansas
city: Wichita
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state: Kansas
city: Wichita
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state: Kansas
city: Bardstown
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state: Kentucky
city: Metairie
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state: Louisiana
city: Bridgeton
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state: Missouri
city: Kansas City
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state: Missouri
city: Saint Louis
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state: Missouri
city: Lincoln
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state: Nebraska
city: Lincoln
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state: Nebraska
city: Omaha
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state: Nebraska
city: Omaha
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state: Nebraska
city: Charlotte
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state: North Carolina
city: Raleigh
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state: North Carolina
city: Raleigh
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state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Fargo
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state: North Dakota
city: Cincinnati
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state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
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state: Ohio
city: Dayton
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state: Ohio
city: Dayton
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state: Ohio
city: Corvallis
country: United States
state: Oregon
city: Grants Pass
country: United States
state: Oregon
city: Erie
country: United States
state: Pennsylvania
city: Hermitage
country: United States
state: Pennsylvania
city: McMurray
country: United States
state: Pennsylvania
city: Upper Saint Clair
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state: Pennsylvania
city: Warwick
country: United States
state: Rhode Island
city: Charleston
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state: South Carolina
city: Charleston
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state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Jackson
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state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Tullahoma
country: United States
state: Tennessee
city: Corpus Christi
country: United States
state: Texas
city: Fort Worth
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state: Texas
city: Fort Worth
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state: Texas
city: San Antonio
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city: Waxahachie
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state: Texas
city: Draper
country: United States
state: Utah
city: Layton
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city: Murray
country: United States
state: Utah
city: Orem
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: South Jordan
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: West Jordan
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state: Utah
city: Burke
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
city: Charlottesville
country: United States
state: Virginia
city: Midlothian
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: