One-, Three-, Five-, Eight- and Ten-Year Data on the Long- Term Immunogenicity of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) in Adults and Adolescents
- Conditions
- Active immunization against tetanus, diphtheria and pertussisMedDRA version: 18.1Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: PTClassification code 10069577Term: Pertussis immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: PTClassification code 10054131Term: Tetanus immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-005843-15-Outside-EU/EEA
- Lead Sponsor
- Sanofi Pasteur Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 144
Subjects who were enrolled in Groups 3, 4 and 5 of the original Study TC9704, received Tdap Vaccine and provided blood samples.
Subjects in the other 2 study groups did not receive the investigational vaccine and thus were not followed for long-term immunogenicity (LTI) assessment.
Inclusion criteria are the same as in the original study (Td9704):
1. Age =12 years but <55 years of age.
2. Signed, witnessed and dated informed consent that was obtained prior to the first study intervention.
3. Judged to be in good health on the basis of medical history.
4. Able to cooperate with requirements of the study (i.e. able to speak, read and write English, have home telephone, expect to be available for adverse event monitoring for at least 3 months after the immunization).
5. If the participant was female, she confirmed she was using an effective method of contraception for the length of the trial and had a negative pregnancy test prior to vaccination OR had had a history of tubal ligation OR hysterectomy OR was post menopausal (at least 1 year no menses) from the
initiation of the study OR their only sexual partner had been sterilized (if male). (Effective method of contraception included abstinence, oral contraceptives, IUDs, diaphragm or condom providing they are used with contraceptive foam, sponge or cream.)
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 144
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria are the same as in the original study (Td9704):
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, 8 years and 10 years after vaccination with Tdap Vaccine.;Secondary Objective: Not applicable.;Primary end point(s): None. Only observational evaluations were performed at 10 years post-vaccination for subjects who were adolescents at the time of vaccination (12-17 years of age) and adults at the time of vaccination (18-54 years of age), and adolescents and adults combined at the time of vaccination.;Timepoint(s) of evaluation of this end point: 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.