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

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

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®.

Study Overview

• Status: Completed
• Conditions: Meningitis; Meningococcal Infection
• Intervention / Treatment: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Bangalore, India, 560070
  • Mumbai, India, 400022
  • New Delhi, India, 110002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; 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®); 0.5 mL, Intramuscular; 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

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Medical Director, Sanofi Pasteur SA.

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: March 11, 2010
• First Submitted That Met QC Criteria: March 12, 2010
• First Posted (Estimate): March 15, 2010

Study Record Updates

• Last Update Posted (Estimate): February 6, 2012
• Last Update Submitted That Met QC Criteria: February 2, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Menactra®; Meningococcal Infection; Meningitis, Bacterial
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Meningitis; Meningococcal Infections
• Other Study ID Numbers: MTA51; UTN: U1111-1111-5608 (Other Identifier: WHO)