Study of a Single Dose of Meningococcal Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) in Japanese Subjects

Phase 3

Completed

Conditions: Meningitis
Meningococcal Meningitis
Meningococcal Infections

Interventions: Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Registration Number: NCT01519713

Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief Summary: This study is designed to assess the safety and immunogenicity of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (SP284) to support registration of the product in Japan.

Primary Objective:

* To describe the seroprotection rate \[% of subjects with serum bactericidal assay using baby rabbit complement (SBA-BR) ≥1:128\] to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age

Secondary Objectives:

* To describe the safety following receipt of SP284 vaccine in subjects 2 through 55 years of age

* To describe the immune responses to meningococcal antigens (serogroups A, C, Y and W-135) following vaccination with SP284 vaccine in subjects 2 through 55 years of age.

Detailed Description: All participants will receive a single injection of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine on Day 0 and undergo immunogenicity assessment and safety monitoring post-vaccination.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 200

Inclusion Criteria

Aged 2 through 55 years on the day of inclusion
For subjects ≥ 20 years of age: Informed consent form has been signed and dated by the subjects. For subjects 2 to 19 years of age: Informed consent form has been signed and dated by the parent(s) or other legal representative. Also subjects 7 to 11 years of age will provide assent and subjects 12 to 19 years of age will provide written assent form.
Able to attend all scheduled visits and to comply with all trial procedures
For a woman of childbearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination.

Exclusion Criteria

Any acute and/or serious disease/illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically
Known systemic hypersensitivity to any of the vaccine components, or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine
Known or suspected congenital or current/ previous acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion
Planned participation in another clinical trial during the present trial period
Receipt of blood or blood-derived products in the past 3 months, which might interfere with assessment of the immune response
Receipt of any vaccine within the four weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least two weeks before the study vaccine
Planned receipt of any vaccine during the trial period
Clinical or known serological evidence of systemic illness including hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV) infection
Ineligible according to the investigator's clinical judgment
Known pregnancy, or suspected pregnancy or a positive (serum and/or urine) pregnancy test
Currently breast feeding a child
Known thrombocytopenia, contraindicating intramuscular (IM) vaccination
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
Identified as employee of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family member (i.e., immediate, husband, wife and their children, adopted or natural) of the employees or the Investigator
Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine
History of Guillain-Barré Syndrome.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adults Study Group	Meningococcal polysaccharide diphtheria toxoid conjugate	Participants will receive a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate vaccine.
Adolescents Study Group	Meningococcal polysaccharide diphtheria toxoid conjugate	Participants will receive a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate vaccine.
Children Study Group	Meningococcal polysaccharide diphtheria toxoid conjugate	Participants will receive a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate vaccine.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine	28 Days post-vaccination	Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR). Sero protection was defined as SBA-BR titer of ≥ 1:128.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:8 Following Vaccination With One Dose of Menactra® Vaccine	28 Days post-vaccination	Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Number of Participants With a 4-Fold Rise in Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers on Day 28 From Day 0 Following Vaccination With One Dose of Menactra® Vaccine.	28 Days post-vaccination	Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine	Days 0 and 28 post-vaccination	Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean of Individual Titer Ratio Following Vaccination With One Dose of Menactra® Vaccine	28 Days post-vaccination	Functional antibody activity against meningococcal serogroups A, C, Y and W-135 antigens were determined by using a serum bovine assay using a baby rabbit complement (SBA-BR).
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Following Vaccination With One Dose of Menactra® Vaccine	Day 0 up to Day 28 post-vaccination	Solicited injection site reactions: Pain, Erythema and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia. Grade 3 solicited reactions were defined as: Pain incapacitating (children) and prevents daily activities (adolescents and adults). Fever ≥ 39.0°C; Headache, Malaise and Myalgia, significant, prevents daily activities.