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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01086969
First Posted: March 15, 2010
Last Update Posted: February 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi
  Purpose

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®.

Condition Intervention Phase
Meningococcal Infection Meningitis Biological: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®) Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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


Enrollment: 300
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01086969


Locations
India
Bangalore, India, 560070
Mumbai, India, 400022
New Delhi, India, 110002
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur SA.
  More Information

Additional Information:
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01086969     History of Changes
Other Study ID Numbers: MTA51
UTN: U1111-1111-5608 ( Other Identifier: WHO )
First Submitted: March 11, 2010
First Posted: March 15, 2010
Results First Submitted: January 3, 2012
Results First Posted: February 3, 2012
Last Update Posted: February 6, 2012
Last Verified: February 2012

Keywords provided by Sanofi:
Meningococcal Infection
Meningitis, Bacterial
Menactra®

Additional relevant MeSH terms:
Meningitis
Meningococcal Infections
Central Nervous System Diseases
Nervous System Diseases
Neisseriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections