A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration. Primary Objectives: To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination. To describe the safety profile of participants after one dose of Menactra®.

Detailed Description
-----------------
Participants will be enrolled in three age cohorts: Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age to receive a single dose of Menactra®. They will be followed for a duration of 30 days after vaccination.

Official Title
-----------------
Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India

Conditions
-----------------
Meningococcal Infection, Meningitis

Intervention / Treatment
-----------------
* Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Aged 2 to 11 years or Aged 12 to 17 years or Aged 18 to 55 years of age on the day of inclusion For participants aged 2 to 11 years: Provision of informed consent form signed by the parent(s) or legal representative. For participants aged 12 to 17 years: Provision of assent form signed by the participant and informed consent form signed by the parent(s) or legal representative. For participants aged 18 to 55 years: Provision of informed consent form signed by the participant. If the participant or the participant's parents or legally accepted representative (participants aged 2 to 17 years) are illiterate, an independent witness is required to sign the consent form. Participant and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for participants aged 2 to 17 years' females not of child-bearing potential or not sexually active) Exclusion Criteria : For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for participants aged 2 to 17 years' females not of child-bearing potential or not sexually active) Breast-feeding woman Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination Planned participation in another clinical trial during the present trial period Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response Receipt or planned receipt of any vaccine (other than influenza vaccine which can be given 2 weeks or more before vaccination) in the 4 weeks preceding or following the trial vaccination Known Human Immunodeficiency Virus (HIV), Hepatitis B surface (HBs) antigen , or Hepatitis C seropositivity as reported by the participant/parent/guardian and/or based on medical history History of documented invasive meningococcal disease Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent Personal or family history of Guillain-Barré Syndrome Temporary contraindications delaying vaccination until resolved: Febrile illness (temperature ≥38.0°C) or moderate or severe acute illness/infection on the day of vaccination Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Participants in three age cohorts - Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age will be enrolled. | Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)<br>* 0.5 mL, Intramuscular<br>* Other names: Menactra®;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination | Antibodies to Menactra vaccine were measured by the Serum bactericidal assay baby rabbit complement (SBA BR) Test. | Baseline and 21 days post-vaccination | 
| Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination | Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test. | Day 0 and Day 30 post-vaccination | 
| Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination | Antibodies to Menactra antigens determined by the serum bactericidal assay baby rabbit complement (SBA-BR) test. | Day 0 to 30 post-vaccination | 
| Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination | Solicited injection site: Pain, Erythema (Redness), and Swelling. Solicited Systemic reaction: Fever (Temperature), Headache, Malaise, and Myalgia | Day 0 to 7 post-vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meningococcal Infection, Meningitis, Bacterial, Menactra®