Immunogenicity and Safety of Menactra® Vaccine in Subjects Aged 9 to 23 Months in India and in the Russian Federatio

Phase 3

Completed

• Registration Number: CTRI/2014/12/005272
• Lead Sponsor: Sanofi Pasteur SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

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 Criteria

- 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

- Influenza vaccination, which may be received at least 2 weeks before study vaccines.

- 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

- 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

- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 38.0°C).

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified