Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 - 12 Years Old

Sanofi

Status and phase

Completed

Phase 3

Conditions

Diphtheria

Pertussis

Tetanus

Treatments

Biological: Diphtheria and Tetanus toxoids adsorbed

Biological: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed

Study type

Interventional

Funder types

Industry

Identifiers

NCT02089347

U1111-1124-7550 (Other Identifier)

Td536 (EFC12579)

Details and patient eligibility

About

The aim of the study is to generate additional safety and immunogenicity data to support the registration of the product in Japan.

Primary objectives:

To demonstrate the non-inferiority of SP306 versus DT (DT 0.1mL) vaccine in terms of diphtheria and tetanus booster response rate (proportion of subjects with booster responses) and seroprotection rate (percentage of subjects with antitoxin concentrations ≥0.1 IU/mL) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age.
To evaluate the immune response of SP306 against the pertussis antigens PT and FHA in terms of booster response rate (proportion of subjects with booster responses) at 28 days (window 28-35 days) after one injection in Japanese adolescents 11-12 years of age.

Secondary objectives:

To further evaluate the immune response of the study vaccines against diphtheria, tetanus and pertussis antigens.
To assess the safety of the study vaccines after one injection in Japanese adolescents 11-12 years of age.

Full description

Study participants will receive either a single dose of SP306 vaccine intramuscularly or a dose of DT vaccine subcutaneously. They will be monitored after vaccination for immediate adverse events (AEs) solicited injection site and systemic reactions and unsolicited AEs including serious adverse events throughout the study period, approximately 28 days (+7 days).

Enrollment

534 patients

Sex

All

Ages

11 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Aged 11 or 12 years and considered healthy on the day of inclusion
Informed consent form and assent form signed and dated by the parent(s) / legal representative(s) and the subject respectively
Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e., received 4 doses of Japanese-produced DTaP vaccine), confirmed by checking immunization records and have not yet undergone additional DT vaccination
Able to attend all scheduled visits and to comply with all trial procedures
For female subjects, either pre-menarchal, or post-menarchal with a negative urine pregnancy test.

Exclusion criteria

Any conditions or diseases which, in the opinion of the Investigator:
would pose a health risk to the subject
or might interfere with the ability to participate fully in the study
or might interfere with evaluation of the vaccine
or would otherwise make participation inappropriate according to the Investigator's clinical judgment
History of diphtheria, tetanus, pertussis, confirmed either clinically, serologically, or microbiologically
Suspected or known hypersensitivity to any of the vaccine components or history of a life threatening reaction to a vaccine containing the same substances of the study vaccine
Vaccination in the last 5 years against tetanus, diphtheria, and/or pertussis
Known or suspected congenital immunodeficiency, or current / previous acquired immunodeficiency, or current / previous receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy, or current / previous (within the last 6 months) systemic corticosteroid therapy
Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the trial inclusion
Planned participation in another clinical trial during the present trial period
Receipt of blood or blood-derived products in the past 3 months, that might interfere with assessment of the immune response
Receipt of any vaccine within the 4 weeks preceding the trial vaccination, except for influenza vaccination, which may be received at least 2 weeks before the study vaccine
Planned receipt of any vaccine during the trial period
Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (HIV) infection
At high risk for diphtheria, tetanus or pertussis infection during the trial
Known pregnancy, or a positive urine pregnancy test
Currently breastfeeding a child
Known thrombocytopenia or history of thrombocytopenia
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion
History of acute disseminated encephalomyelitis, encephalopathy, Guillain-Barré Syndrome (GBS), or autoimmune disease
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Current alcohol abuse or drug addiction that might interfere with the ability to comply with trial procedures
Identified as an employee of an Investigator, a study center, a study-affiliated vendor, or the Sponsor, with direct or indirect involvement in the proposed study or other studies under the direction of that Investigator or study center; or identified as a spouse or child (whether natural or adopted) of such an employee.