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

Immunogenicity and Safety of the Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (SP306) as a Booster in Japanese Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Pertussis; Tetanus; Diphtheria
• Intervention / Treatment: Biological: (ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Aichi, Japan
  • Ibaraki, Japan
  • Nagano, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Tdap Vaccine; ADACEL®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®	Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL, post-vaccination.	Day 28 post-vaccination
Percentage of Participants With Booster Response to Diphtheria and Tetanus Antigens Following Vaccination With ADACEL®	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.	Day 28 post-vaccination
Percentage of Participants With Booster Response to Pertussis Antigens, Pertussis Toxoid and Filamentous Hemagglutinin Following Vaccination With ADACEL®	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)	Day 28 post-vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination With ADACEL®	Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.1 IU/mL.	Day 0 pre-vaccination
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Pre-vaccination and Post-vaccination With ADACEL®	Seroprotection was defined as the percentage of participants with antibody concentration of ≥0.01 IU/mL.	Day 0 (pre-vaccination) and day 28 post-vaccination
Percentage of Participants With Seroprotection Against Diphtheria and Tetanus Antigens Pre-vaccination and Post-vaccination With ADACEL®	Seroprotection was defined as the percentage of participants with antibody concentration of ≥1.0 IU/mL.	Day 0 (pre-vaccination) and day 28 post-vaccination
Geometric Mean Concentrations With Respect to Diphtheria and Tetanus Antibodies Pre- and Post-vaccination With ADACEL®		Day 0 (pre-vaccination) and Day 28 post-vaccination
Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®		Day 0 (pre-vaccination) and Day 28 post-vaccination
Percentage of Participants With Booster Response to Pertussis Antigens, Pertactin and Fimbriae Following Vaccination With ADACEL®	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)	Day 28 post-vaccination
Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With ADACEL®	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.	Day 0 up to Day 7 post-vaccination

Collaborators and Investigators

• Sponsor: Sanofi Pasteur, a Sanofi Company

Publications and helpful links

Helpful Links

• Related Info
• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: September 17, 2012
• First Submitted That Met QC Criteria: September 17, 2012
• First Posted (Estimate): September 21, 2012

Study Record Updates

• Last Update Posted (Estimate): February 21, 2014
• Last Update Submitted That Met QC Criteria: February 19, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Pertussis; Diphtheria; Tetanus; Acellular pertussis; Tdap vaccine; ADACEL®
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neurologic Manifestations; Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Neuromuscular Manifestations; Actinomycetales Infections; Clostridium Infections; Hypocalcemia; Calcium Metabolism Disorders; Corynebacterium Infections; Whooping Cough; Tetanus; Diphtheria; Tetany; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: Td540; U1111-1124-7671 (Other Identifier: WHO)