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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Meningococcal Infection

Meningitis

Treatments

Biological: Meningococcal Diphtheria Toxoid Vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01890759

MTA70

CTRI/2014/12/005272 (Registry Identifier)

U1111-1122-2171 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

9 to 17 months old

Volunteers

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.