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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01642589
First received: July 13, 2012
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

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.

Condition Intervention Phase
Meningitis
Meningococcal Disease
Biological: Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
Biological: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Versus Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®) in Subjects 11 to 55 Years of Age in South Korea

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine [ Time Frame: 28 Days post-vaccination ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination [ Time Frame: Day 0 (pre-vaccination) and 28 days post-vaccination ] [ Designated as safety issue: No ]
    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) at ≥ 1:8 dilution.

  • Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination. [ Time Frame: Day 0 (pre-vaccination) and 28 days post-vaccination ] [ Designated as safety issue: No ]
    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) at ≥ 1:128 dilution.

  • 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 [ Time Frame: Day 0 (pre-vaccination) and 28 days post-vaccination ] [ Designated as safety issue: No ]
    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).

  • Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine [ Time Frame: Day 0 up to Day 28 post-vaccination ] [ Designated as safety issue: No ]

    Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.

    Grade 3 injection site reactions: Pain - Significant, prevents daily activity; Redness and Swelling - > 100 mm. Grade 3 Systemic reactions: Fever - ≥ 39.0°C; Headache, Malaise, and Myalgia - Significant, prevents daily activity.



Enrollment: 300
Study Start Date: July 2012
Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Menactra® Group
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®)
0.5 mL, Intramuscular
Other Name: Menactra®
Active Comparator: Tdap - Adacel® Group
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
0.5 mL, Intramuscular
Other Name: Adacel®

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.

  Eligibility

Ages Eligible for Study:   11 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642589

Locations
Korea, Republic of
Incheon, Chung gu, Korea, Republic of
Gyeonggi do, Dongan gu Anyang, Korea, Republic of
Seoul, Dongdaemun gu, Korea, Republic of
Seoul, Seodaemun gu, Korea, Republic of
Seoul, Seongbuk gu, Korea, Republic of
Gyeonggi do, Suwon, Korea, Republic of
Gangwon do, Wonju, Korea, Republic of
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01642589     History of Changes
Other Study ID Numbers: MTA52, U1111-1122-2028
Study First Received: July 13, 2012
Results First Received: August 29, 2013
Last Updated: November 8, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Sanofi:
Meningitis
Meningococcal disease
Menactra®
Adacel®

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Nervous System Diseases

ClinicalTrials.gov processed this record on October 29, 2014