Clinical trial NCT01642589: Safety and Immunogenicity Study for Use of Menactra® Versus Adacel® in Subjects 11 to 55 Years of Age in South Korea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningitis
Meningococcal Disease
Keywords: Meningitis
Meningococcal disease
Menactra®
Adacel®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-07-17
Enrollment: 300
Sex: ALL
Minimum age (years): 11
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Percentage of Participants With Seroconversion Following Vaccination With Either Menactra® or Adacel® Vaccine
timeFrame: 28 Days post-vaccination
Secondary outcomes:
measure: Percentage of Participants With Functional Antibody Titers at ≥1:8 Dilution Before and After Menactra® or Adacel® Vaccination
timeFrame: Day 0 (pre-vaccination) and 28 days post-vaccination
measure: Percentage of Participants With Functional Antibody Titers at ≥1:128 Dilution Before and After Menactra® or Adacel® Vaccination.
timeFrame: Day 0 (pre-vaccination) and 28 days post-vaccination
measure: 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
timeFrame: Day 0 (pre-vaccination) and 28 days post-vaccination
measure: Number of Participants Reporting Solicited Injection Site and Systemic Events Following Vaccination With Either Menactra® or Adacel® Vaccine
timeFrame: Day 0 up to Day 28 post-vaccination
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
state: Chung gu
city: Gyeonggi do
country: Korea, Republic of
state: Dongan gu Anyang
city: Seoul
country: Korea, Republic of
state: Dongdaemun gu
city: Seoul
country: Korea, Republic of
state: Seodaemun gu
city: Seoul
country: Korea, Republic of
state: Seongbuk gu
city: Gyeonggi do
country: Korea, Republic of
state: Suwon
city: Gangwon do
country: Korea, Republic of
state: Wonju
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References: