A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India.
- Registration Number
- CTRI/2010/091/000157
- Lead Sponsor
- Sanofi Pasteur SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
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)
1) 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).
2) Breast-feeding woman.
3) Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
4) 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.
5) 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.
6) Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
7) Current alcohol abuse or drug addiction that may interfere with the subjects ability to comply with trial procedures.
8) Receipt of blood or blood-derived products in the past 3 months, that might interfere with the assessment of immune response.
9) 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.
10) 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.
11) History of documented invasive meningococcal disease.
12) Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine.
13) Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular vaccination.
14) Subjects deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized without his/her consent.
15) 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method