Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT02089347
First received: March 13, 2014
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

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 BIK® 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.

Condition Intervention Phase
Tetanus
Diphtheria
Pertussis
Biological: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
Biological: Diphtheria and Tetanus toxoids adsorbed
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) Given Intramuscularly Compared to Diphtheria and Tetanus Toxoids Adsorbed (DT) Given Subcutaneously in Japanese Adolescents 11 - 12 Years of Age

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of subjects with booster responses to vaccine diphtheria and tetanus antigens post-vaccination with either SP306 or DT BIK® [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Diphtheria booster response will be measured by a toxin neutralization test; Tetanus booster response will be measured by an enzyme-linked immunosorbent assay (ELISA).

  • Percentage of subjects with booster responses against pertussis antigens (Pertussis toxoid [PT] and Filamentous hemagglutinin [FHA]) post-vaccination with either SP306 or DT BIK® [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Pertussis booster response Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA) will be measured by enzyme-linked immunosorbent assay (ELISA)


Secondary Outcome Measures:
  • Diphtheria and tetanus antitoxin geometric mean concentrations (GMC) before and post-vaccination with either SP306 or DT BIK® [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ] [ Designated as safety issue: No ]
  • Number and percentage of participants reporting solicited injection-site reactions, solicited systemic reactions, unsolicited systemic reactions, and serious adverse events occurring throughout the trial [ Time Frame: Day 0 up to Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia


Estimated Enrollment: 534
Study Start Date: March 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SP306 Group
Participants randomized to receive SP306 vaccine intramuscularly
Biological: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
0.5 mL, intramuscularly.
Other Names:
  • Adacel
  • SP306 (in Japan)
Active Comparator: DT Biken Group
Participants randomized to receive DT BIK® vaccine subcutaneously
Biological: Diphtheria and Tetanus toxoids adsorbed
0.1 mL, Subcutaneously
Other Name: DT BIK®

Detailed Description:

Study participants will receive either a single dose of SP306 vaccine intramuscularly or a dose of DT BIK® 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).

  Eligibility

Ages Eligible for Study:   11 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 TdaP 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02089347

Locations
Japan
Aichi, Japan, 451 8511
Chiba, Japan, 299 4503
Fukui, Japan, 918 8205
Fukui, Japan, 910 0833
Gunma, Japan, 372 0817
Hyogo, Japan, 655 0017
Ibaraki, Japan, 312 0057
Kagoshima, Japan, 890 0034
Kanagawa, Japan, 223 0051
Nagano, Japan, 381 0025
Okayama, Japan, 701 0205
Okayama, Japan, 712 8064
Osaka, Japan, 574 0046
Shizuoka, Japan, 426 0067
Shizuoka, Japan, 420 8623
Tokyo, Japan, 146 0023
Tokyo, Japan, 167 0052
Tokyo, Japan, 183 0042
Tokyo, Japan, 146 0095
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT02089347     History of Changes
Other Study ID Numbers: Td536 (EFC12579), U1111-1124-7550
Study First Received: March 13, 2014
Last Updated: July 7, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi:
Tetanus
Diphtheria
Pertussis
TdaP vaccine
DT BIK®

Additional relevant MeSH terms:
Diphtheria
Tetanus
Tetany
Whooping Cough
Actinomycetales Infections
Bacterial Infections
Bordetella Infections
Calcium Metabolism Disorders
Clostridium Infections
Corynebacterium Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Hypocalcemia
Infection
Metabolic Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Manifestations
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014