Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea

NCT ID: NCT01642589

Last Updated: 2013-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-06-30

Brief Summary

The aim of the study is to assess safety and immunogenicity of a single dose of Menactra® in support of registration of the vaccine in South Korea.

Primary Objective:

• To demonstrate that the seroconversion rate is higher than 60% for serogroups A, C, Y and W-135, 28 days after a single dose of Menactra®.

Secondary objectives:

• To demonstrate the superiority of Menactra® versus Adacel® in terms of seroconversion rate for serogroups A, C, Y, and W-135, 28 days after a single dose of vaccine
• To describe the safety profile after 1 dose of Menactra® or Adacel® vaccine.
• To describe the Serum Bactericidal Assay Using Baby Rabbit (SBA-BR) Complement titers before and 28 days after a single dose of Menactra® or Adacel® vaccine.

Detailed Description

All participants will receive a single dose of vaccine, and will be assessed for immunogenicity at baseline (pre-vaccination) and at 28 days post-vaccination.

Safety data, including serious adverse events (SAEs) will be collected for Day 0 through Day 28 post-vaccination.

Conditions

Meningitis; Meningococcal Disease

Keywords

Meningitis; Meningococcal disease; Menactra®; Adacel®

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Menactra® Group

Participants will receive Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)

Group Type: EXPERIMENTAL

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Tdap - Adacel® Group

Participants will receive Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)

Group Type: ACTIVE_COMPARATOR

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

Other Intervention Names

Menactra®; Adacel®

Eligibility Criteria

Inclusion Criteria

• Aged 11 to 55 years on the day of inclusion
• Subject aged 11 to 19 years: assent form signed and dated by the subject and informed consent form signed and dated by at least 1 parent or another legal representative
• Subject aged 20 to 55 years: informed consent form signed and dated by the subject

If the subject or the subject's parent(s) or legal representative is illiterate, an independent witness is required to sign the consent form.

• Subject and parent/legally acceptable representative (if applicable) are able to attend all scheduled visits and comply with all trial procedures
• Covered by health insurance.

Exclusion Criteria

• Subject is pregnant, or lactating, or of child-bearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post menopausal for at least 1 year, surgically sterile (hysterectomy or bilateral tubal ligation), or using an effective method of contraception or abstinence for 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 a medical procedure
• Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the trial vaccination. Monovalent pandemic influenza vaccines and multivalent pandemic influenza vaccines can be administered at any time during the study
• Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine
• Vaccination against diphtheria or tetanus in the past 5 years or any previous vaccination with either Adacel® or any other Tdap 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 invasive meningococcal disease, confirmed either clinically, serologically, or microbiologically
• At high risk for invasive meningococcal disease during the trial
• 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
• Thrombocytopenia, bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular 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 at a stage that could interfere with trial conduct or completion, in the opinion of the investigator
• Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided
• Received oral or injectable antibiotic therapy within the 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, 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
• Personal history of Guillain-Barré Syndrome.

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Sanofi Pasteur SA

Locations

Incheon, Chung gu, South Korea

Gyeonggi-do, Dongan Gu Anyang, South Korea

Seoul, Dongdaemun gu, South Korea

Seoul, Seodaemun gu, South Korea

Seoul, Seongbuk gu, South Korea

Gyeonggi-do, Suwon, South Korea

Gangwon Do, Wonju, South Korea

Countries

South Korea

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

U1111-1122-2028

Identifier Type: OTHER

Identifier Source: secondary_id

MTA52

Identifier Type: -

Identifier Source: org_study_id