Clinical trial NCT01086969: A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Infection
Meningitis
Keywords: Meningococcal Infection
Meningitis, Bacterial
Menactra®
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-03-15
Enrollment: 300
Sex: ALL
Minimum age (years): 2
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of Participants With Vaccine Antibody Titers at ≥ 8 Before and After Menactra Vaccination
timeFrame: Baseline and 21 days post-vaccination
measure: Serum Bactericidal Assay Baby Rabbit Complement (SBA BR) Geometric Mean Titers Before and Post Menactra Vaccination
timeFrame: Day 0 and Day 30 post-vaccination
measure: Percentage of Participants With at Least a 4-fold Increase in Antibodies to Menactra Vaccine Antigens Post Vaccination
timeFrame: Day 0 to 30 post-vaccination
measure: Number of Participants Reporting a Solicited Injection Site or Systemic Reactions Following Menactra Vaccination
timeFrame: Day 0 to 7 post-vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Bangalore
country: India
city: Mumbai
country: India
city: New Delhi
country: India
Study officials:
affiliation: Sanofi Pasteur SA.
name: Medical Director
role: STUDY_DIRECTOR
References: