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

• Register: EUCTR
• Last refreshed on: 1 February 2016
• Main ID: EUCTR2015-005844-32-Outside-EU/EEA
• Date of registration: 26/01/2016
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur Limited
• Public title: 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
• Scientific title: 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
• Target sample size: 150
• Recruitment status: NA
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-005844-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 0

Countries of recruitment

Canada

Contacts

• Name: Oladayo Oyelola
• Affiliation: SANOFI PASTEUR

• Name: Oladayo Oyelola
• Affiliation: SANOFI PASTEUR

Key inclusion & exclusion criteria

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).



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Active immunization against tetanus, diphtheria and pertussis
MedDRA version: 18.1 Level: PT Classification code 10054129 Term: Diphtheria immunisation System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 18.1 Level: PT Classification code 10069577 Term: Pertussis immunisation System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 18.1 Level: PT Classification code 10054131 Term: Tetanus immunisation System Organ Class: 10042613 - Surgical and medical procedures

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Trade Name: Adacel, Covaxis, Triaxis
Product Name: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)
Pharmaceutical Form: Suspension for injection

Primary Outcome(s)

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.

Primary end point(s): None. Only observational evaluation is performed.

Secondary Objective: Not applicable.

Timepoint(s) of evaluation of this end point: Evaluated 10 years post vaccination

Secondary Outcome(s)

Secondary end point(s): Not applicable.

Timepoint(s) of evaluation of this end point: Not applicable.

Secondary ID(s)

Td9805-LT

Source(s) of Monetary Support

Sanofi Pasteur

Sanofi Pasteur Limited