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

NCT02089347 | Completed Phase 3 Results

• 2 other identifiers: Td536 (EFC12579)U1111-1124-7550
• Study Type: interventional
• Target: 534
• Locations: 1 country
• Sites: 19

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.

Conditions

Tetanus; Diphtheria; Pertussis

Keywords

Tetanus; Diphtheria; Pertussis; TdaP vaccine; DT vaccine

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants With Diphtheria and Tetanus Post-vaccination Booster Response Following Vaccination With Either SP306 or DT

  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

  Day 28 post-vaccination

• Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Post-booster Vaccination With Either SP306 or DT Vaccine

  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

  Day 28 post-vaccination

• Percentage of Participants With Pertussis Booster Response Following Vaccination With Either SP306 or DT Vaccine

  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.

  Day 28 post-vaccination

Secondary Outcomes (6)

• Percentage of Participation With Seroprotection to Diphtheria and Tetanus Antigens Before Vaccination With Either SP306 or DT Vaccine

  Pre-vaccination (Day 0)

• Percentage of Participants With Seroprotection to Diphtheria and Tetanus Antigens Before and Following Vaccination With Either SP306 or DT Vaccine

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Geometric Mean Concentration of Diphtheria and Tetanus Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine

  Day 0 (pre-vaccination) and Day 28 post-vaccination

• Percentage of Participants With Pertussis (Pertactin and Fimbriae Types 2 and 3) Booster Response Following Vaccination With Either SP306 or DT Vaccine

  Day 28 post-vaccination

• Geometric Mean Concentration of Pertussis Antibodies Before and Following Vaccination With Either SP306 or DT Vaccine

  Day 0 (pre-vaccination) and Day 28 post-vaccination

Study Arms (2)

SP306 Group

EXPERIMENTAL

Participants randomized to receive SP306 vaccine intramuscularly

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

DT Group

ACTIVE COMPARATOR

Participants randomized to receive DT vaccine subcutaneously

Biological: Diphtheria and Tetanus toxoids adsorbed

Interventions

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

0.5 mL, intramuscularly.

Also known as: Adacel, SP306 (in Japan)

SP306 Group

Diphtheria and Tetanus toxoids adsorbed BIOLOGICAL

0.1 mL, Subcutaneously

Also known as: DT vaccine

DT Group

Eligibility Criteria

• Age: 11 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (19)

Unknown Facility

Aichi, 451 8511, Japan

Location

Unknown Facility

Chiba, 299 4503, Japan

Location

Unknown Facility

Fukui, 910 0833, Japan

Location

Unknown Facility

Fukui, 918 8205, Japan

Location

Unknown Facility

Gunma, 372 0817, Japan

Location

Unknown Facility

Hyōgo, 655 0017, Japan

Location

Unknown Facility

Ibaraki, 312 0057, Japan

Location

Unknown Facility

Kagoshima, 890 0034, Japan

Location

Unknown Facility

Kanagawa, 223 0051, Japan

Location

Unknown Facility

Nagano, 381 0025, Japan

Location

Unknown Facility

Okayama, 701 0205, Japan

Location

Unknown Facility

Okayama, 712 8064, Japan

Location

Unknown Facility

Osaka, 574 0046, Japan

Location

Unknown Facility

Shizuoka, 420 8623, Japan

Location

Unknown Facility

Shizuoka, 426 0067, Japan

Location

Unknown Facility

Tokyo, 146 0023, Japan

Location

Unknown Facility

Tokyo, 146 0095, Japan

Location

Unknown Facility

Tokyo, 167 0052, Japan

Location

Unknown Facility

Tokyo, 183 0042, Japan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Tetanus; Diphtheria; Whooping Cough

Interventions

adacel; Diphtheria-Tetanus Vaccine

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Corynebacterium Infections; Actinomycetales Infections; Bordetella Infections; Gram-Negative Bacterial Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined

Results Point of Contact

• Title: Medical Director
• Organization: Sanofi Pasteur Inc.

RegistryContactUs@sanofipasteur.com

Study Officials

• Medical Director

  Sanofi Pasteur Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 17, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: March 1, 2015
• Last Updated: May 30, 2017
• Results First Posted: October 8, 2015

Record last verified: 2017-04

Locations

JP (19)