Overview

This trial is active, not recruiting.

Conditions meningitis, meningococcal meningitis, meningococcal infections
Treatments meningococcal polysaccharide (serogroups a, c, y, and w) tetanus toxoid conjugate vaccine, meningococcal (groups a, c, y and w 135) polysaccharide diphtheria toxoid conjugate vaccine
Phase phase 3
Sponsor Sanofi Pasteur, a Sanofi Company
Start date July 2016
End date May 2017
Trial size 3344 participants
Trial identifier NCT02842853, MET43, U1111-1161-3060

Summary

The purpose of the study is 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 and to demonstrate the immune 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 vs licensed MCV4 vaccine.

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.

- 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 licensed MCV4 vaccine.

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 licensed MCV4 vaccine 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 licensed MCV4 vaccine in the adolescent population (10 to 17 years old)

Observational Objectives:

- To describe the safety profile of MenACYW conjugate vaccine and that of the licensed MCV4 vaccine.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Participants randomized to receive a dose of MenACYW conjugate vaccine from Lot 1
meningococcal polysaccharide (serogroups a, c, y, and w) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine
0.5 mL, Intramuscular (Lot 1)
(Experimental)
Participants randomized to receive a dose of MenACYW conjugate vaccine from Lot 2
meningococcal polysaccharide (serogroups a, c, y, and w) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine
0.5 mL, Intramuscular (Lot 2)
(Experimental)
Participants randomized to receive a dose of MenACYW conjugate vaccine from Lot 3
meningococcal polysaccharide (serogroups a, c, y, and w) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine
0.5 mL, Intramuscular (Lot 3)
(Active Comparator)
Participants randomized to receive a dose of licensed MCV4 vaccine
meningococcal (groups a, c, y and w 135) polysaccharide diphtheria toxoid conjugate vaccine Licensed MCV4 vaccine
0.5 mL, Intramuscular

Primary Outcomes

Measure
Geometric mean titer ratios (GMTRs) of antibodies against meningococcal serogroups A, C, Y, and W measured by hSBA post-vaccination between lots for immune lot consistency
time frame: Day 30 post-vaccination
Number of participants with seroresponse to meningococcal serogroups A, C, Y, and W following vaccination with a single dose of MenACYW conjugate vaccine or Licensed MCV4 vaccine
time frame: Day 30 post-vaccination

Secondary Outcomes

Measure
Number of adolescent participants with seroresponse to meningococcal serogroups A, C, Y, and W post-vaccination with a single dose of MenACYW conjugate vaccine or Licensed MCV4 vaccine
time frame: Day 30 post-vaccination
Number of adults participants with seroresponse to meningococcal serogroups A, C, Y, and W post-vaccination with a single dose of MenACYW conjugate vaccine or Licensed MCV4 vaccine
time frame: Day 30 post-vaccination
Number of participants reporting solicited reactions, unsolicited adverse events and serious adverse events following vaccination with a lot of MenACYW conjugate vaccine or Licensed MCV4 vaccine
time frame: Day 0 up to Day 180 post-vaccination

Eligibility Criteria

Male or female participants from 10 years up to 55 years old.

Inclusion Criteria: - Aged 10 to 55 years on the day of inclusion - Informed consent form has been signed and dated by the subject (aged 18 to 55 years) or assent form has been signed and dated by the subject and informed consent form has been signed and dated by the parent(s) or guardian (for subjects aged 10 to < 18 years) - Subject (≥ 18 years) or subject (10 to < 18 years) and parent / guardian are able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: - Subject is pregnant, or 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 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, subjects with persistent complement deficiency, with anatomic or functional asplenia, or subjects 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 subject or the subject'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, is 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°F]). A prospective subject 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.

Additional Information

Official title Immune Lot Consistency, Immunogenicity, and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults Aged 10 to 55 Years
Description Healthy meningococcal-vaccine naïve adolescents and adults will be enrolled, randomized and will receive a single dose of either MenACYW conjugate vaccine from 1 of the 3 lots (Lot 1, Lot 2, or Lot 3) or licensed MCV4 vaccine. They will be assessed for immunogenicity at baseline (pre-vaccination) and at 1 month post-vaccination. Safety information will be collected post-vaccination and through the entire study.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Sanofi.