Status:
COMPLETED
Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federation
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Meningitis
Meningococcal Infection
Eligibility:
All Genders
9-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to assess the immunogenicity and safety of Menactra® vaccine given as a two-dose series in infants and toddlers. Primary Objectives: * To assess the seroprotection rate ...
Detailed Description
Study participants will receive 2 doses on Menactra® vaccine at 3 to 6 months apart and will be monitored for safety and immunogenicity. The planned duration of each subject's participation in the tr...
Eligibility Criteria
Inclusion
- Male and female subjects aged 9 to 17 months on the day of inclusion
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative(s) (if applicable)
- Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and to comply with all trial procedures.
Exclusion
- Participation in the 4 weeks preceding inclusion or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks preceding each trial vaccination or planned receipt of any vaccine in the 4 weeks following each trial vaccination, except for:
- (i) influenza vaccination, which may be received at least 2 weeks before study vaccines.
- (ii) measles (M) or measles, mumps, rubella (MMR) routine vaccination, which can be administered concomitantly with the first dose of study vaccine as per routine immunization schedule
- (iii) for subjects enrolled at Indian sites: oral poliomyelitis vaccine (OPV) received during National Immunization Days (NIDs) and supplementary immunization activity days (SIADs)
- Previous vaccination against meningococcal disease with either the study vaccine or another meningococcal vaccine
- Receipt of immune globulins, blood or blood-derived products in the past 3 months
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
- History of meningococcal diseases, confirmed either clinically, serologically, or microbiologically
- At high risk, in the opinion of the Investigator, for meningococcal disease during the trial
- Known or suspected systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- Known thrombocytopenia, contraindicating intramuscular vaccination
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
- In an emergency setting, or hospitalized involuntarily
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- For subjects enrolled at Indian sites: Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C).
- For subjects enrolled at Russian sites: Acute disease of any severity on the day of vaccination or febrile illness (axillary temperature ≥ 37.0°C).
- A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
- Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
- Personal history of Guillain-Barré Syndrome.
Key Trial Info
Start Date :
June 25 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2016
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT01890759
Start Date
June 25 2013
End Date
April 12 2016
Last Update
April 19 2022
Active Locations (8)
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1
Vadodara, Gujarat, India, 390022
2
Kolkata, West Bengal, India, 700017
3
Lucknow, India, 226003
4
Vellore, India, 632004