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

NCT01519713 | Completed Phase 3 Results

• 2 other identifiers: MTA76 (SFY12080)U1111-1124-7479
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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.

Conditions

Meningitis; Meningococcal Meningitis; Meningococcal Infections

Keywords

Meningitis; Meningococcal Meningitis; Meningococcal Infections; Meningococcal conjugate Vaccine; Menactra®

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Serum Bovine Albumin Baby Rabbit (SBA-BR) Titers of >=1:128 Following Vaccination With One Dose of Menactra® Vaccine

  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.

  28 Days post-vaccination

Secondary Outcomes (5)

• 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

• 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

• Serum Bovine Albumin Baby Rabbit (SBA-BR) Geometric Mean Titers Following Vaccination With One Dose of Menactra® Vaccine

  Days 0 and 28 post-vaccination

• 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

• 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

Study Arms (3)

Adults Study Group

EXPERIMENTAL

Participants will receive a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate vaccine.

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Adolescents Study Group

EXPERIMENTAL

Participants will receive a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate vaccine.

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Children Study Group

EXPERIMENTAL

Participants will receive a single dose of Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate vaccine.

Biological: Meningococcal polysaccharide diphtheria toxoid conjugate

Interventions

Meningococcal polysaccharide diphtheria toxoid conjugate BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®, SP284

Adolescents Study Group; Adults Study Group; Children Study Group

Eligibility Criteria

• Age: 2 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (3)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Shinjuku, Tokyo, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Meningitis; Meningitis, Meningococcal; Meningococcal Infections

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neuroinflammatory Diseases; Nervous System Diseases; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Aventis K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: January 27, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: May 28, 2013
• Results First Posted: May 28, 2013

Record last verified: 2013-05

Locations

JP (3)