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 April 2016
End date March 2017
Trial size 810 participants
Trial identifier NCT02752906, MET56, U1111-1161-2710

Summary

The aim of the study is to describe the safety and antibody response to revaccination with MenACYW conjugate vaccine in persons who received their first quadrivalent meningococcal conjugate vaccine dose at ≥ 10 years of age.

Primary Objective:

- To demonstrate the non-inferiority of the vaccine seroresponse of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of MenACYW conjugate vaccine compared to those observed following the administration of a booster dose of a licensed Meningococcal Conjugate Vaccine (MCV4) in subjects who were first vaccinated with 1 dose of MCV4, 4 to 10 years before the booster dose.

Secondary Objectives:

- To evaluate the vaccine seroresponse of meningococcal serogroups A, C, Y, and W measured using human serum bactericidal assay (hSBA) in serum specimens collected 6 days after vaccination in a subset of subjects

- To evaluate the antibody responses (geometric mean titers) to serogroups A, C, Y, and W measured using hSBA on Day 0 (pre-vaccination) and Day 30 after vaccination

Observational Objectives:

- To describe the antibody titers against meningococcal serogroups A, C, Y, and W measured by hSBA assessed at Day 0, Day 6, and Day 30 days after vaccination

- To describe the safety profile of MenACYW conjugate vaccine compared to that of a licensed MCV4 after booster vaccination.

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
meningococcal polysaccharide (serogroups a, c, y, and w) tetanus toxoid conjugate vaccine
0.5 mL, Intramuscular
(Active Comparator)
Participants randomized to receive a dose of a licensed MCV4
meningococcal (groups a, c, y and w 135) polysaccharide diphtheria toxoid conjugate vaccine
0.5 mL, Intramuscular

Primary Outcomes

Measure
Percentage of participants with seroresponse to meningococcal serogroups A, C, Y, and W at baseline and post vaccination with a single dose of MenACYW conjugate vaccine or a licensed MCV4
time frame: Day 0 (pre vaccination) and Day 30 post vaccination

Secondary Outcomes

Measure
Number of participants with seroresponse to meningococcal serogroups A, C, Y, and W at baseline and post vaccination with a single dose of MenACYW conjugate vaccine or a licensed MCV4
time frame: Day 6 post vaccination
Geometric mean titer ratios (GMTRs) of antibodies against meningococcal serogroups A, C, Y, and W measured by hSBA after vaccination with MenACYW conjugate vaccine or a licensed MCV4
time frame: Day 0 (pre vaccination) and 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 a licensed MCV4
time frame: Day 0 up to Day 180 post vaccination

Eligibility Criteria

Male or female participants at least 15 years old.

Inclusion Criteria: - Aged ≥ 15 years on the day of inclusion - Subject has documented record of having received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years prior to enrollment - Subject aged 15 to < 18 years: assent form signed and dated by the subject and informed consent form (ICF) signed and dated by the parent or guardian - Subject aged ≥ 18 years: ICF signed and dated by the subject - Subjects aged 15 to < 18 years: both the subject and parent / guardian are able to attend all scheduled visits and to comply with all trial procedures - Subjects aged ≥ 18 years: able to attend all scheduled visits and to comply with all trial procedures Exclusion Criteria: - Subject is pregnant, 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 before Day 30 visit except for influenza vaccination, which may be received at least 2 weeks before study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines - Previous vaccination against meningococcal disease with either an investigational or approved 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 travelling 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 vaccine(s) used in the trial or to a vaccine containing any of the same substances - Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine - Personal history of Guillain-Barré syndrome - Verbal report of thrombocytopenia, 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 - 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 the Investigator's 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 Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults
Description Healthy adolescents and adults who had received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years previously will be randomized to receive either 1 dose of MenACYW conjugate vaccine or a licensed MCV4 . All participants will undergo immunogenicity assessment at baseline (pre-vaccination) and 1 month post-vaccination and will also be evaluated for safety up to Day 180 post-vaccination. In addition, a subset will have an additional blood sample collected at 6 days post-vaccination for immunogenicity assessment.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Sanofi.