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

Meningitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642589
• Other study ID #: MTA52
• Secondary ID: U1111-1122-2028
• Status: Completed
• Phase: Phase 3
• First received: July 13, 2012
• Last updated: November 8, 2013
• Start date: July 2012
• Est. completion date: June 2013

Study information

• Verified date: November 2013
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Meningococcal Disease
• Meningococcal Infections

Intervention

Biological:
• Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
0.5 mL, Intramuscular
• Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Percentage of Participants With Functional Antibody Titers at =1:8 Dilution Before and After Menactra® or Adacel® Vaccination	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.	Day 0 (pre-vaccination) and 28 days post-vaccination	No
Secondary	Percentage of Participants With Functional Antibody Titers at =1:128 Dilution Before and After Menactra® or Adacel® Vaccination.	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.	Day 0 (pre-vaccination) and 28 days post-vaccination	No
Secondary	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	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).	Day 0 (pre-vaccination) and 28 days post-vaccination	No
Secondary	Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine	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.	Day 0 up to Day 28 post-vaccination	No

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