Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine
- Conditions
- Meningococcal InfectionsMeningococcal MeningitisMeningitis
- Interventions
- Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineBiological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine
- Registration Number
- NCT02752906
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- Brief Summary
The aim of the study was to describe the safety and antibody response to booster administration with Meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine in participants who received their first quadrivalent meningococcal Conjugate vaccine dose in the past 4-10 years.
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 Menactra® in participants who were first vaccinated with 1 dose of a quadrivalent meningococcal vaccine 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 120 participants.
* 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 antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days after vaccination with MenACYW Conjugate vaccine or Menactra® measured by rabbit serum bactericidal assay (rSBA) in a subset of participants.
* To describe the safety profile of MenACYW Conjugate vaccine compared to that of a licensed Menactra® after booster vaccination.
- Detailed Description
Healthy adolescents and adults who had received 1 dose of a quadrivalent meningococcal Conjugate vaccine 4 to 10 years previously were randomized to receive either 1 dose of MenACYW Conjugate vaccine or licensed Menactra®. All participants underwent immunogenicity assessment at baseline (pre-vaccination) and post-vaccination and were also evaluated for safety up to Day 180 post-vaccination. In addition, a subset had an additional blood sample collected at 6 days post-vaccination for immunogenicity assessment.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 810
- Aged >= 15 years on the day of inclusion.
- Participant has documented record of having received 1 dose of a quadrivalent meningococcal conjugate vaccine 4 to 10 years prior to study vaccination.
- Participant aged 15 to < 18 years: assent form signed and dated by the participant and informed consent form (ICF) signed and dated by the parent or guardian.
- Participant aged >=18 years: ICF signed and dated by the participant.
- Participants aged 15 to < 18 years: both the participant and parent / guardian were able to attend all scheduled visits and to comply with all trial procedures.
- Participants aged >= 18 years: able to attend all scheduled visits and to comply with all trial procedures.
- Participant was 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, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants 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°Fahrenheit [F]). A prospective participant 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Menactra® Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Healthy, meningococcal- vaccine-primed adolescents (\>= 15 to \< 18 years) or adults (\>= 18 years) received a single dose of Menactra ® vaccine on Day 0. MenACYW Conjugate Vaccine Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine Healthy, meningococcal vaccine-primed adolescents (greater than or equal to \[\>=\] 15 to less than \[\< \]18 years) or adults (\>= 18 years) received a single dose of a MenACYW Conjugate vaccine on Day 0.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Day 30 (post-vaccination) The serum bactericidal assay using human complement (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.
- Secondary Outcome Measures
Name Time Method Geometric Mean Titers Against Meningococcal Serogroups A, C, Y, and W Antibodies Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Day 30 (post-vaccination) Meningococcal antibody responses against Serogroups A, C, Y, and W were measured by hSBA.
Number of Participants With Solicited Injection Site Reactions or Systemic Reactions Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine Within 7 days post-vaccination A Solicited Reaction (SR) was an Adverse Event (AE) that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). Solicited injection site reactions: Pain (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significantly prevent daily activity), erythema and swelling (Grade 1: \>=25 millimeter \[mm\] to \<= 50 mm, Grade 2: \>=51 to \<=100 mm, Grade 3: \> 100 mm). Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius (°C) to \<=38.4°C, Grade 2: \>=38.5°C to \<=38.9 °C, Grade 3: \>= 39°C), headache, malaise, and myalgia (Grade 1: no interference with activity, Grade 2: some interference with activity, Grade 3: significant; prevents daily activity. Number of participants with any of the Grade (1, 2 or 3) and with each Grade (1, 2 and 3) solicited injection-site and systemic reactions were reported.
Percentage of Participants With Seroresponse to Meningococcal Serogroups A, C, Y, and W Following Vaccination With Either MenACYW Conjugate Vaccine or Menactra® Vaccine at Day 6 After Vaccination Day 6 (post-vaccination) 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.
Trial Locations
- Locations (30)
Investigational Site Number 026
🇺🇸Mesa, Arizona, United States
Investigational Site Number 013
🇺🇸Bardstown, Kentucky, United States
Investigational Site Number 021
🇺🇸Kettering, Ohio, United States
Investigational Site Number 019
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 003
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 018
🇺🇸Woburn, Massachusetts, United States
Investigational Site Number 031
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 014
🇺🇸La Puente, California, United States
Investigational Site Number 005
🇺🇸Downey, California, United States
Investigational Site Number 015
🇺🇸Metairie, Louisiana, United States
Investigational Site Number 007
🇺🇸Hermitage, Pennsylvania, United States
Investigational Site Number 022
🇺🇸Jonesboro, Arkansas, United States
Investigational Site Number 006
🇺🇸Rochester, New York, United States
Investigational Site Number 011
🇺🇸Fairfield, Ohio, United States
Investigational Site Number 029
🇺🇸San Diego, California, United States
Investigational Site Number 001
🇺🇸San Diego, California, United States
Investigational Site Number 020
🇺🇸Salt Lake City, Utah, United States
Investigational Site Number 008
🇺🇸Kansas City, Missouri, United States
Investigational Site Number 030
🇵🇷San Juan, Puerto Rico
Investigational Site Number 017
🇺🇸South Jordan, Utah, United States
Investigational Site Number 016
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 032
🇺🇸Dothan, Alabama, United States
Investigational Site Number 023
🇺🇸Lincoln, Nebraska, United States
Investigational Site Number 010
🇺🇸Troy, Michigan, United States
Investigational Site Number 027
🇺🇸Nicholasville, Kentucky, United States
Investigational Site Number 012
🇺🇸Fargo, North Dakota, United States
Investigational Site Number 028
🇺🇸Saint Louis, Missouri, United States
Investigational Site Number 025
🇺🇸Huber Heights, Ohio, United States
Investigational Site Number 024
🇺🇸Tullahoma, Tennessee, United States
Investigational Site Number 009
🇺🇸Erie, Pennsylvania, United States