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

Meningitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01086969
• Other study ID #: MTA51
• Secondary ID: UTN: U1111-1111-
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2010
• Last updated: February 2, 2012
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: February 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 55 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningitis
• Meningococcal Infection
• Meningococcal Infections

Intervention

Biological:
• Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No

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