An open-label, multicentre study to evaluate the immunogenicity and safety of one dose of a diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (REPEVAX®) followed by 2 doses of a diphtheria, tetanus and poliomyelitis vaccine (REVAXIS®) in subjects of 40 years of age or older without a previous diphtheria and tetanus-containing booster within the last 20 years

• Register: EUCTR
• Last refreshed on: 21 August 2012
• Main ID: EUCTR2010-023086-21-DE
• Date of registration: 19/10/2010
• Prospective Registration: Yes
• Primary sponsor: Sanofi Pasteur MSD S.N.C.
• Public title: An open-label, multicentre study to evaluate the immunogenicity and safety of one dose of a diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (REPEVAX®) followed by 2 doses of a diphtheria, tetanus and poliomyelitis vaccine (REVAXIS®) in subjects of 40 years of age or older without a previous diphtheria and tetanus-containing booster within the last 20 years
• Scientific title: An open-label, multicentre study to evaluate the immunogenicity and safety of one dose of a diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (REPEVAX®) followed by 2 doses of a diphtheria, tetanus and poliomyelitis vaccine (REVAXIS®) in subjects of 40 years of age or older without a previous diphtheria and tetanus-containing booster within the last 20 years
• Date of first enrolment: 13/12/2010
• Target sample size: 335
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-023086-21
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
Subjects have to meet all the following criteria to be eligible for inclusion:
1. Adults aged =40 years at Visit 1
2. No receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years before Visit 1
3. Having signed the informed consent form before any specific study procedure
4. Subject able to attend all scheduled visits and to comply with all study procedures
5. For France only: subject affiliated to a health social security system
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects must not be included in the study if they meet at least one of the following criteria:
1. Medically diagnosed pertussis disease within the last 10 years prior to Visit 1
2. Receipt of any inactivated vaccine within 14 days prior to Visit 1, or planned vaccination, other than study vaccines, 14 days before or after each study vaccination or study blood sample
3. Receipt of any live vaccine within 28 days prior to Visit 1, or planned vaccination, other than study vaccines, 28 days before or after each study vaccination or study blood sample
4. Febrile illness (body temperature =38.0°C) or moderate or severe acute illness/infection on the day of each vaccination, according to investigator judgment (in that case, vaccination could be postponed)
5. Known pregnancy or positive urine pregnancy test for women of child-bearing age. A woman who is of reproductive potential must agree to remain abstinent or use (or have her partner use) acceptable methods of birth control during the study period
6. History of hypersensitivity or anaphylactic or other allergic reactions to formaldehyde, glutaraldehyde, neomycin, polymyxin B and streptomycin, or to any of the vaccine components, or history of a life-threatening reaction to the study vaccines or a vaccine containing any of the same substances
7. History of Guillain Barré syndrome or brachial neuritis following a previous vaccination
8. History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or neurological disorders after an injection with the same antigens
9. Known or suspected immune dysfunction that is caused by a medical condition, or any other cause
- Examples: immune dysfunction including congenital immunodeficiency, human immunodeficiency virus (HIV) infection, organ or bone marrow transplantation, acute or chronic leukaemias, lymphoma, Hodgkin’s disease, multiple myeloma, other conditions affecting the bone marrow or the lymphatic system or generalized malignancy
- Exceptions: subjects with prostate or breast cancer with no chemotherapeutic drugs or receiving only hormone blocking drugs, subjects with skin cancer who are not receiving radiation therapy or chemotherapy, and subjects with a history of other malignancies who have been disease-free for at least 6 months can be included
10. Receipt of immunosuppressive therapy or expected to receive immunosuppressive therapy during the study e.g.:
- Chemotherapy agents to treat cancer received within 6 months prior to Visit 1 or planned treatment with chemotherapy agents during the study
- Daily -or on alternate days- systemic corticosteroids at a dose =20 mg/day of prednisone (or equivalent) for =14 days in the 4 weeks prior or after each vaccination
- Immunomodulator therapy within 6 weeks prior or after each vaccination
11. Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks prior to Visit 1 contraindicating intramuscular vaccination
12. Receipt of immunoglobulins or any blood products, other than autologous blood transfusion, given within the 5 months prior to Visit 1 or planned treatment with immunoglobulins or blood products during the study
13. Chronic disease (e.g., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric) that is unstable or any intercurrent illness that might interfere with the ability to participate fully in the study; or interfere with evaluation of the vaccine
14. Subject deprived of freedom by an administra

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

Health Condition(s) or Problem(s) studied

Evaluation of the immunogenicity and safety of one dose of a diphtheria, tetanus, acellular pertussis and poliomyelitis vaccine (REPEVAX®) followed by 2 doses of a diphtheria, tetanus and poliomyelitis vaccine (REVAXIS®). The MedDRA term corresponding to classification code 10069577 is Pertussis immunisation.
MedDRA version: 13.1 Level: PT Classification code 10054129 Term: Diphtheria immunisation System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 13.1 Level: LLT Classification code 10053386 Term: Poliomyelitis vaccine System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 13.1 Level: PT Classification code 10069577 Term: Pertussis immunisation System Organ Class: 10042613 - Surgical and medical procedures
MedDRA version: 13.1 Level: PT Classification code 10054131 Term: Tetanus immunisation System Organ Class: 10042613 - Surgical and medical procedures

Intervention(s)

Trade Name: Repevax®
Pharmaceutical Form: Suspension for injection
CAS Number: 0
Other descriptive name: DIPHTHERIA TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 2-
CAS Number: 0
Other descriptive name: TETANUS TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 20-
CAS Number: 0
Other descriptive name: PERTUSSIS TOXOID
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 2.5-
CAS Number: 0
Other descriptive name: PERTUSSIS FILAMENTOUS HAEMAGGLUTININ
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
CAS Number: 0
Other descriptive name: PERTUSSIS PERTACTIN
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 3-
CAS Number: 0
Other descriptive name: PERTUSSIS FIMBRIAL AGGLUTINOGENS (FIM) 2 AND 3
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 5-
CAS Number: 0
Other descriptive name: POLIOVIRUS (INACTIVATED) TYPE 1 PRODUCED ON VERO CELLS
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 40-
CAS Number: 0
Other descriptive name: POLIOVIRUS (INACTIVATED) TYPE 2 PRODUCED ON VERO CELLS
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 8-
CAS Number: 0
Other descriptive name: POLIOVIRUS (INACTIVATED) TYPE 3 PRODUCED ON VERO CELLS
Concentration unit: DAgU D antigen unit(s)
Concentration type: equal
Concentration number: 32-

Trade Name: Revaxis®
Pharmaceutical Form: Suspension for injection
CAS Number: 0
Other descriptive name: DIPHTHERIA TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 2-
CAS Number: 0
Other descriptive name: TETANUS TOXOID
Concentration unit: IU international unit(s)
Concentration type: not less then
Concentration number: 20-
CAS Number: 0
Other descriptive name: POLI

Primary Outcome(s)

Primary end point(s): After Dose 3:
· The post-vaccination seroprotection rate for diphtheria is defined as the percentage of subjects with antibody titre =0.1 IU/mL (seroneutralisation).
· The post-vaccination seroprotection rate for tetanus is defined as the percentage of subjects with antibody titre =0.1 IU/mL (ELISA).
· The post-vaccination seroprotection rate for poliomyelitis type 1, 2 and 3 defined as the percentage of subjects with antibody titre =8 (1/dil) (seroneutralisation).

After Dose 1:
· The post-vaccination percentage of subjects with antibody titre =5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM)

Secondary Objective: If the primary objective is achieved, to determine whether 1 or 2 doses of a vaccine containing Td-IPV valences induce an acceptable response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years.

To describe the immune responses to REPEVAX in these subjects.

To describe the immune responses to REVAXIS administered 1 and 6 months after the administration of REPEVAX in these subjects.

Main Objective: To demonstrate that 3 doses of a vaccine containing Td-IPV valences administered in a 0, 1 and 6-month schedule induce an acceptable immune response in terms of seroprotection rates (SPR) against diphtheria, tetanus and poliomyelitis 1, 2 and 3, in subjects of 40 years of age or older with no diphtheria- and tetanus-containing booster within the last 20 years.

To evaluate the percentage of subjects with antibody titre =5 EU/mL (ELISA) for each of the pertussis components (PT, FHA, PRN and FIM) after 1 dose of REPEVAX in these subjects.

Secondary ID(s)

RPV04C