A Follow-Up To Study Td506: Safety and Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) Compared to Tetanus and Diphtheria Toxoids Adsorbed (Td) in Adolescents and Adults 11 – 64 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: EUCTR2015-005845-30-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: 189

Inclusion Criteria

At the sites participating in each of the Long term follow-ups, all subjects in the original study who received a vaccination and provided blood samples were asked to provide a follow-up sample. For the 10-year follow-up, only Tdap subjects were to be included.
Are the trial subjects under 18? yes
Number of subjects for this age range: 44
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 145
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Pregnancy or nursing a child.

2. Known or suspected primary or acquired 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 5].

3. Malignancy, allergy shots or is receiving immunosuppressive therapy (e.g., daily systemic prednisone = 1 mg/kg would be excluded, participants who are taking topical and inhaled steroids could be included in the study as would participants on a short course” of oral steroids, =7 days, as long as there are not two courses within the previous two weeks prior to vaccination).

4. Prior receipt of any pertussis, diphtheria or tetanus containing vaccines within the past 5 years.

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

6. Known impairment of neurologic function or currently active seizure disorder or currently required medication for seizures.

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

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

9. Known or suspected allergy to any of the vaccines or vaccine components for tetanus, diphtheria and pertussis intended for use in the study.

10. Daily use of non-steroidal anti-inflammatory drugs (NSAIDs).

11. Receipt of any vaccine within 30 days of receiving study vaccine, or is planning to receive another vaccine before the 2nd visit.

12. Has a known chemical dependency (e.g., alcoholism or intravenous drug use but not including nicotine or caffeine) based on investigator judgment.

13. Has received an investigational product as part of another clinical trial within 30 days prior to study enrollment and can not be enrolled in another clinical trial.

14. Has a known or suspected acute infectious respiratory illness at the time of vaccination with active symptoms and signs including one or more of the following: rhinorrhea, new cough, pharyngitis, respiratory problems (e.g. wheezing, shortness of breath).

15. Has any condition which, in the opinion of the investigator, would pose a health risk to the participant or interfere with the evaluation of the vaccine.

16. Previous reactions to pertussis, diphtheria or tetanus vaccine including immediate anaphylaxis, encephalopathy within 7 days, or seizure within 3 days of receiving the vaccine.

Relative Contraindications for All Immunizations (the dose will be deferred) for febrile illness with
temperature = 38.0oC (100.4oF) oral within previous 72 hours of vaccination defer the
immunization for a minimum of 48 hours from the scheduled immunization.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Long-term follow-up study to describe the profile of antibody levels after booster vaccination with Tdap vaccine or Td vaccine at 1-month, 1-, 3-, and 5-years postvaccination and Tdap only at 10 years post-vaccination.;Secondary Objective: Not applicable.;Primary end point(s): Levels of pertussis anti-PT, anti-FHA, anti-PRN, and anti-FIM antibodies, antidiphtheria antibodies, and anti-tetanus antibodies at 1-year, and/or 3-years, and/or 5-years and/or 10-years post-vaccination.;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.