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

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Status and phase

Phase 3


Meningococcal Infection


Biological: Meningococcal Diphtheria Toxoid Vaccine

Study type


Funder types



CTRI/2014/12/005272 (Registry Identifier)
U1111-1122-2171 (Other Identifier)

Details and patient eligibility


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 (percentage of subjects with a serum bactericidal assay using human complement [SBA-HC] titer ≥ 1:8) 28 days after the second of 2 doses of Menactra® administered 3 to 6 months apart. Secondary Objectives: To assess the immune responses to meningococcal antigens (serogroups A, C, Y, and W-135) 28 days following the second vaccination with Menactra® using SBA-HC and SBA-BR titers. To assess the safety profile of Menactra® after each and any vaccination.

Full 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 trial will be from 118 to 215 days.


300 patients




9 to 17 months old


Accepts Healthy Volunteers

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:

  • (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.

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

300 participants in 1 patient group

Meningococcal Diphtheria Toxoid Vaccine
Experimental group
Participants at age 9 to 17 months of enrollment will receive 2 doses on Menactra vaccine at 3 to 6 months apart
Biological: Meningococcal Diphtheria Toxoid Vaccine

Trial contacts and locations



Data sourced from

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