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

NCT01086969 | Completed Phase 3 Results

• 2 other identifiers: MTA51UTN: U1111-1111-5608
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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®.

Conditions

Meningococcal Infection; Meningitis

Keywords

Meningococcal Infection; Meningitis, Bacterial; Menactra®

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Study Group

EXPERIMENTAL

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®)

Interventions

Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®) BIOLOGICAL

0.5 mL, Intramuscular

Also known as: Menactra®

Study Group

Eligibility Criteria

• Age: 2 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Unknown Facility

Bangalore, 560070, India

Location

Unknown Facility

Mumbai, 400022, India

Location

Unknown Facility

New Delhi, 110002, India

Location

Related Links

• Related Info

MeSH Terms

Conditions

Meningococcal Infections; Meningitis; Meningitis, Bacterial

Interventions

Meningococcal Vaccines

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuroinflammatory Diseases; Nervous System Diseases; Central Nervous System Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur SA.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2010
• First Posted: March 15, 2010
• Study Start: June 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: June 1, 2011
• Last Updated: February 6, 2012
• Results First Posted: February 3, 2012

Record last verified: 2012-02

Locations

IN (3)