Diphtheria, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Diphtheria, Tetanus, Poliomyelitis, Pertussis (acellular), Biological/vaccine
Brief summary
Primary 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 objectives: * 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
Interventions
1 dose of REPEVAX (0.5 mL) at Day 0, 1 dose of REVAXIS (0.5 mL) 1 month later and 1 dose of REVAXIS 6 month later
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged ≥40 years * No receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years
Exclusion criteria
* Medically diagnosed pertussis disease within the last 10 years * Receipt of medication / vaccine that may interfere with study assessments * Febrile illness or moderate or severe acute illness/infection * Know pregnancy * History of hypersensitivity or anaphylactic or other allergic reactions 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 * History of Guillain Barré syndrome or brachial neuritis following a previous vaccination * History of encephalopathy of unknown origin within 7 days after immunization with a pertussis-containing vaccine or neurological disorders * Known or suspected immune dysfunction * Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination * Chronic disease or intercurrent illness that might interfere with study assessments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diphtheria seroprotection rate | 28 to 35 days afeter each vaccine administration |
| Tetanus seroprotection rate | 28 to 35 days after each vaccine administration |
| Polio seroprotection rate | 28 to 35 days after each vaccine administration |
| Pertussis response rate | 28 to 35 days after REPEVAX administration |
Secondary
| Measure | Time frame |
|---|---|
| Unsolicited injection-site adverse reactions and systemic adverse events | From day 0 to day 28 following REPEVAX and REVAXIS vaccination |
| Number and proportion of Serious adverse events | From the first vaccination to the last visit of the subject |
| Solicited injection-site reactions, solicited systemic reactions | From day 0 to day 7 following REPEVAX and REVAXIS vaccination |
Countries
France, Germany
Outcome results
None listed