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

Tetanus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689324
• Other study ID #: Td540
• Secondary ID: U1111-1124-7671
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 17, 2012
• Last updated: February 19, 2014
• Start date: September 2012
• Est. completion date: May 2013

Study information

• Verified date: February 2014
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 12 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Tetanus
• Whooping Cough

Intervention

Biological:
• (ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis
0.5 mL, Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Other	Geometric Mean Concentrations With Respect to Pertussis Antibodies Pre- and Post-vaccination With ADACEL®		Day 0 (pre-vaccination) and Day 28 post-vaccination	No
Other	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	No
Other	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	No
Primary	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	No
Primary	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	No
Primary	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	No

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