Study of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (ADACEL®) as a Booster in Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01689324
First received: September 17, 2012
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

This study is designed to assess the immunogenicity and safety of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (ADACEL®, Tdap vaccine) as a booster dose in adolescents in Japan.

Primary Objective:

  • To assess the immunogenicity of Tdap (SP306) when administered as a single dose in Japanese adolescents

Secondary Objective:

  • To assess the safety of Tdap vaccine when administered as a single dose in Japanese adolescents.

Condition Intervention Phase
Pertussis
Tetanus
Diphtheria
Biological: (ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) as a Booster in Japanese Adolescents

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.

  • Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL® [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]

    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.

    Tetanus 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 ≤ 2.7 IU/mL; or a ≥ 2-fold rise in a subject with a pre-vaccination antitoxin concentration > 2.7 IU/mL.


  • Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL® [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)


Other Outcome Measures:
  • Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL® [ Time Frame: Day 0 pre-vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.

  • Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL® [ Time Frame: Day 0 (pre-vaccination) and day 28 post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.

  • Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL® [ Time Frame: Day 0 (pre-vaccination) and day 28 post-vaccination ] [ Designated as safety issue: No ]
    Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.

  • Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL® [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ] [ Designated as safety issue: No ]
  • Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL® [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ] [ Designated as safety issue: No ]
  • Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL® [ Time Frame: Day 28 post-vaccination ] [ Designated as safety issue: No ]
    Booster responses were defined as: Pre-vaccination antibody concentrations less than the lower limit of quantitation (LLOQ) and a post-vaccination levels ≥ 4x LLOQ; or Pre-vaccination antibody concentrations ≥ LLOQ but < 4x LLOQ, and a 4-fold rise (i.e., post-/pre-vaccination ≥ 4), or Pre-vaccination antibody concentrations ≥ 4x LLOQ and a 2-fold rise (i.e., post-/pre-vaccination ≥ 2)

  • Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL® [ Time Frame: Day 0 up to Day 7 post-vaccination ] [ Designated as safety issue: No ]

    Solicited injection-site reactions: Pain, Redness, and Swelling. Grade 3: Pain, Significant, prevents daily activity; Redness and Swelling, >100 mm.

    Solicited systemic reactions: Fever (Temperature); Headache, Malaise, and Myalgia. Grade 3: Fever, ≥ 39°C; Headache, Malaise and Myalgia, Significant, prevents daily activity.



Enrollment: 43
Study Start Date: September 2012
Study Completion Date: May 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Group
Participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0.
Biological: (ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis
0.5 mL, Intramuscular
Other Names:
  • ADACEL®
  • Tdap Vaccine

Detailed Description:

All participants will receive a single booster dose of Tdap vaccine (ADACEL®) on Day 0 and undergo immunogenicity assessment from blood samples provided prior to, and 28 days post-vaccination. Tolerability and safety will be monitored up to 28 days post-vaccination.

  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 on the day of inclusion
  • Informed consent form and assent form signed and dated by the parent(s) / legal representative and the subject respectively
  • Completed childhood vaccination against diphtheria, pertussis and tetanus (i.e, received 4 doses of Japanese-produced tetanus toxoid, diphtheria toxoid and acellular pertussis vaccine absorbed [DTaP vaccine]), confirmed by checking immunization records and have not yet undergone additional adsorbed Diphtheria and Tetanus toxoid (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
  • Known systemic 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, contraindicating intramuscular (IM) vaccination, or a history of thrombocytopenia
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
  • 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: NCT01689324

Locations
Japan
Aichi, Japan
Ibaraki, Japan
Nagano, Japan
Sponsors and Collaborators
Sanofi Pasteur, a Sanofi Company
Investigators
Study Director: Medical Director Sanofi Pasteur K.K
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01689324     History of Changes
Other Study ID Numbers: Td540, U1111-1124-7671
Study First Received: September 17, 2012
Results First Received: November 7, 2013
Last Updated: February 19, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Sanofi:
Pertussis
Tetanus
Diphtheria
Acellular pertussis
ADACEL®
Tdap vaccine

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

ClinicalTrials.gov processed this record on September 22, 2014