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

• ClinicalTrials.gov Identifier: NCT01086969
• Recruitment Status: Completed
• First Posted: March 15, 2010
• Results First Posted: February 3, 2012
• Last Update Posted: February 6, 2012
• Sponsor: Sanofi
• Information provided by (Responsible Party): Sanofi

Tracking Information

• First Submitted Date: March 11, 2010
• First Posted Date: March 15, 2010
• Results First Submitted Date: January 3, 2012
• Results First Posted Date: February 3, 2012
• Last Update Posted Date: February 6, 2012
• Study Start Date: June 2010
• Actual Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 2, 2012)

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

Original Primary Outcome Measures (submitted: March 12, 2010)

• To provide information concerning the immunogenicity in terms of the serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination. [ Time Frame: 30 days post-vaccination ]
• To provide information concerning the safety of Menactra® vaccine in terms of solicited injection site and systemic reactions, unsolicited adverse events, and serious adverse events. [ Time Frame: 0-30 days post-vaccination ]

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Meningococcal Infection
• Meningitis

Intervention

Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)

0.5 mL, Intramuscular

Other Name: Menactra®

Study Arms

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.

Intervention: Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 12, 2010): 300
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: June 2011
• Actual Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 2 Years to 55 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT01086969
• Other Study ID Numbers: MTA51; UTN: U1111-1111-5608 ( Other Identifier: WHO )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sanofi
• Original Responsible Party: Medical Director, Sanofi Pasteur SA
• Current Study Sponsor: Sanofi
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Sanofi Pasteur SA.

• PRS Account: Sanofi
• Verification Date: February 2012