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

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ClinicalTrials.gov Identifier: NCT02089347
Recruitment Status : Completed
First Posted : March 17, 2014
Results First Posted : October 8, 2015
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE March 13, 2014
First Posted Date  ICMJE March 17, 2014
Results First Submitted Date  ICMJE September 9, 2015
Results First Posted Date  ICMJE October 8, 2015
Last Update Posted Date May 30, 2017
Study Start Date  ICMJE March 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2017)
  • Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT [ Time Frame: Day 28 post-vaccination ]
    Diphtheria booster response was defined as a ≥4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.56 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.56 IU/mL. A tetanus booster response is defined as a ≥ 4-fold rise in pre- to post-vaccination antitoxin concentration in a subject with a pre-vaccination antitoxin concentration ≤ 2.7 IU/mL or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration >2.7 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
  • Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine [ Time Frame: Day 28 post-vaccination ]
    Seroprotection was defined as the proportion of subjects at 28 days post-vaccination with diphtheria and tetanus antitoxin concentration ≥0.1 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
  • Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine [ Time Frame: Day 28 post-vaccination ]
    Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2). Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method.
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • 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 ]
    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 ]
    Pertussis booster response Pertussis toxoid (PT) and Filamentous hemagglutinin (FHA) will be measured by enzyme-linked immunosorbent assay (ELISA)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2017)
  • Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine [ Time Frame: Pre-vaccination (Day 0) ]
    Seroprotection was defined as the proportion of participants with pre-vaccination with diphtheria and tetanus antitoxin concentration ≥ 0.1 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method.
  • Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]
    Seroprotection was defined as the proportion of participants with diphtheria and tetanus antitoxin concentration level ≥ 0.01 IU/mL. Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method.
  • Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]
    Diphtheria antitoxin concentration was assayed by the toxin neutralization test; Tetanus antitoxin concentration was assayed by the enzyme-linked immunosorbent assay (ELISA) method
  • Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine [ Time Frame: Day 28 post-vaccination ]
    Pertussis booster response was defined as a pre-vaccination antibody concentration less than the lower limit of quantitation (LLOQ) and a post-vaccination level ≥ 4XLLOQ; or a pre-vaccination antibody concentration ≥ LLOQ but < 4XLLOQ and a 4-fold rise (i.e. post/pre-vaccination ≥ 4); or a pre-vaccination antibody concentrations ≥ 4XLLOQ and a 2-fold rise (i.e. post/pre-vaccination ≥2). Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method.
  • Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]
    Pertussis antitoxin concentration were assayed by the enzyme-linked immunosorbent assay (ELISA) method
  • Percentage of Participants Reporting Solicited Injection-site and Systemic Reactions Following a Single Booster Dose of SP306 or DT Vaccine [ Time Frame: Day 0 up to Day 7 post-vaccination ]
    Solicited injection-site: Pain, Erythema, Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia. Grade 3 injection-site: Pain Significant, prevents daily activity; Erythema and Swelling >100 mm. Grade 3 systemic reactions: Fever, >39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • 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 ]
  • 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 ]
    Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, and Myalgia
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of SP306 Given Intramuscularly Compared to DT Given Subcutaneously in Japanese Adolescents 11 - 12 Years Old
Official Title  ICMJE 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
Brief Summary

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.
Detailed 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Tetanus
  • Diphtheria
  • Pertussis
Intervention  ICMJE
  • Biological: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
    0.5 mL, intramuscularly.
    Other Names:
    • Adacel
    • SP306 (in Japan)
  • Biological: Diphtheria and Tetanus toxoids adsorbed
    0.1 mL, Subcutaneously
    Other Name: DT vaccine
Study Arms  ICMJE
  • Experimental: SP306 Group
    Participants randomized to receive SP306 vaccine intramuscularly
    Intervention: Biological: Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed
  • Active Comparator: DT Group
    Participants randomized to receive DT vaccine subcutaneously
    Intervention: Biological: Diphtheria and Tetanus toxoids adsorbed
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2014)
534
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02089347
Other Study ID Numbers  ICMJE Td536 (EFC12579)
U1111-1124-7550 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Sanofi Pasteur, a Sanofi Company )
Study Sponsor  ICMJE Sanofi Pasteur, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur Inc.
PRS Account Sanofi
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP