One-, Three-, Five- and Ten-Year Data on the Long-Term Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) in Adolescents 11–14 Years of Age

• Conditions: Active immunization against tetanus, diphtheria and pertussis; MedDRA version: 18.1Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10069577Term: Pertussis immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 18.1Level: PTClassification code 10054131Term: Tetanus immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2015-005844-32-Outside-EU/EEA
• Lead Sponsor: Sanofi Pasteur Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-26
• Last Update Posted: 1 February 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Participation in original Study Td9805 and the receipt of Tdap.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnancy or planning a pregnancy during the study period.

2. Known or suspected primary disease of the immune system (conditions suspected of having an immunologic component such as autoimmune diseases (rheumatoid arthritis or inflammatory bowel disease) will not be excluded unless they meet exclusion criterion 3 or are sufficiently clinically active to meet exclusion criterion 5).

3. Malignancy or receiving immunosuppressive therapy (e.g. daily systemic prednisone 1 mg/kg would be excluded. Participants who were taking topical and inhaled steroids could be included in the study as could participants on a short course” of oral steroids, 5-7 days, as long as there were not two courses within the previous two week period.)

4. Receipt of any pertussis, diphtheria or tetanus containing vaccines within the previous 5 years.

5. Any significant underlying chronic disease, including malignancy, cardiopulmonary disease, renal or hepatic dysfunction.

6. Known impairment of neurologic function or seizure disorder of any etiology.

7. Personal history of physician diagnosed or laboratory confirmed pertussis disease within the previous 2 years.

8. Receipt of blood products or immunoglobulin within the previous 3 months.

9. Known or suspected allergy to any of the vaccines intended for use in the study.

10. Receipt of any vaccine within 2 weeks of receiving a study vaccine.

11. Daily use of non-steroidal anti-inflammatory drugs (NSAIDS).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To describe the antibody levels for tetanus, diphtheria and pertussis at 1 year, 3 years, 5 years and 10 years after vaccination with Tdap Vaccine.;Secondary Objective: Not applicable.;Primary end point(s): None. Only observational evaluation is performed.;Timepoint(s) of evaluation of this end point: Evaluated 10 years post vaccination

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable. ;Timepoint(s) of evaluation of this end point: Not applicable.