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

Meningitis Clinical Trial

Official title:

Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children 2 to 9 Years of Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077438
• Other study ID #: MET35
• Secondary ID: U1111 1161 2625
• Status: Completed
• Phase: Phase 3
• Start date: February 17, 2017
• Est. completion date: October 10, 2017

Study information

• Verified date: March 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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 information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: October 10, 2017
• Est. primary completion date: October 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 9 Years

Eligibility

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.

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Infections
• Meningococcal Meningitis

Intervention

Biological:
• Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate
0.5 milliliter (mL), Intramuscular
• Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine
0.5 mL, Intramuscular

Locations

Country	Name	City	State
Puerto Rico	Investigational Site	San Juan
United States	Investigational Site	Anaheim	California
United States	Investigational Site	Bardstown	Kentucky
United States	Investigational Site	Birmingham	Alabama
United States	Investigational Site	Bridgeton	Missouri
United States	Investigational Site	Cincinnati	Ohio
United States	Investigational Site	Cleveland	Ohio
United States	Investigational Site	Council Bluffs	Iowa
United States	Investigational Site	Dayton	Ohio
United States	Investigational Site	Dothan	Alabama
United States	Investigational Site	Downey	California
United States	Investigational Site	Erie	Pennsylvania
United States	Investigational Site	Fairfield	Ohio
United States	Investigational Site	Goodlettsville	Tennessee
United States	Investigational Site	Grants Pass	Oregon
United States	Investigational Site	Gresham	Oregon
United States	Investigational Site	Hermitage	Pennsylvania
United States	Investigational Site	Jonesboro	Arkansas
United States	Investigational Site	Kansas City	Missouri
United States	Investigational Site	Layton	Utah
United States	Investigational Site	Metairie	Louisiana
United States	Investigational Site	Midlothian	Virginia
United States	Investigational Site	Nicholasville	Kentucky
United States	Investigational Site	Omaha	Nebraska
United States	Investigational Site	Orem	Utah
United States	Investigational Site	Paramount	California
United States	Investigational Site	Roy	Utah
United States	Investigational Site	Salt Lake City	Utah
United States	Investigational Site	Salt Lake City	Utah
United States	Investigational Site	San Diego	California
United States	Investigational Site	South Jordan	Utah
United States	Investigational Site	Syracuse	Utah
United States	Investigational Site	Tucson	Arizona
United States	Investigational Site	Tullahoma	Tennessee
United States	Investigational Site	West Jordan	Utah
United States	Investigational Site	Woburn	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 30 (post-vaccination)
Secondary	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	Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.	Day 30 (post-vaccination)
Secondary	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	Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA.	Day 30 (post-vaccination)
Secondary	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	Antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA.	Day 30 (post-vaccination)
Secondary	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	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.	Day 30 (post-vaccination)
Secondary	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	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.	Day 30 (post-vaccination)

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