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

NCT01642589 | Completed Phase 3 Results

• 2 other identifiers: MTA52U1111-1122-2028
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

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.

Conditions

Meningitis; Meningococcal Disease

Keywords

Meningitis; Meningococcal disease; Menactra®; Adacel®

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine

  Functional antibody activity for anti-meningococcal antibody to serogroups A, C, Y, and W-135 were measured using the Serum bactericidal assay using baby rabbit complement (SBA-BR). Seroconversion was defined as post-vaccination antibody titers of ≥ 4-fold increase from pre-vaccination level.

  28 Days post-vaccination

Secondary Outcomes (4)

• Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination

  Day 0 (pre-vaccination) and 28 days post-vaccination

• Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.

  Day 0 (pre-vaccination) and 28 days post-vaccination

• Geometric Mean Titers of Serum Bactericidal Assay Using Baby Rabbit Complement (SBA-BR) Antibody Against Serogroups A, C, Y, and W-135 Before and After Menactra® or Adacel® Vaccination

  Day 0 (pre-vaccination) and 28 days post-vaccination

• Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine

  Day 0 up to Day 28 post-vaccination

Study Arms (2)

Menactra® Group

EXPERIMENTAL

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

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

Tdap - Adacel® Group

ACTIVE COMPARATOR

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

Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed

Interventions

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

0.5 mL, Intramuscular

Also known as: Menactra®

Menactra® Group

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Adacel®

Tdap - Adacel® Group

Eligibility Criteria

• Age: 11 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (7)

Unknown Facility

Incheon, Chung gu, South Korea

Location

Unknown Facility

Gyeonggi-do, Dongan Gu Anyang, South Korea

Location

Unknown Facility

Seoul, Dongdaemun gu, South Korea

Location

Unknown Facility

Seoul, Seodaemun gu, South Korea

Location

Unknown Facility

Seoul, Seongbuk gu, South Korea

Location

Unknown Facility

Gyeonggi-do, Suwon, South Korea

Location

Unknown Facility

Gangwon Do, Wonju, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Meningitis; Meningococcal Infections

Interventions

Meningococcal Vaccines; Tetanus Toxoid; adacel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Toxoids

Results Point of Contact

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

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur SA

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2012
• First Posted: July 17, 2012
• Study Start: July 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 3, 2013
• Results First Posted: December 3, 2013

Record last verified: 2013-11

Locations

KR (7)