Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Children Aged 2 to 9 Years

Phase 3

Completed

Conditions: Meningitis
Meningococcal Meningitis
Meningococcal Infections

Interventions: Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate
Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine

Registration Number: NCT03077438

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1000

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: MenACYW Conjugate Vaccine	Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate	Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MenACYW Conjugate vaccine on Day 0.
Group 2: MENVEO® Vaccine	Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine	Healthy, meningococcal-vaccine naïve participants aged 2 to 9 years received a single dose of MENVEO® Conjugate vaccine on Day 0.

Primary Outcome Measures

Name	Time	Method
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	Day 30 (post-vaccination)	Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse against serogroups A, C, Y, and W was defined as post-vaccination hSBA titers greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titers less than (\<) 1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.

Secondary Outcome Measures

Name	Time	Method
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	Day 30 (post-vaccination)	Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
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	Day 30 (post-vaccination)	Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA.
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	Day 30 (post-vaccination)	Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination hSBA titers \<1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.
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	Day 30 (post-vaccination)	Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA.
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	Day 30 (post-vaccination)	Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse for serogroups A, C, Y, and W was defined as post-vaccination hSBA titers \>=1:16 for participants with pre-vaccination hSBA titers \<1:8 or at least a 4-fold increase in hSBA titers from pre- to post-vaccination for participants with pre-vaccination hSBA titers \>=1:8.