Clinical trial NCT01287949: Safety and Immunogenicity Study 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
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Poliomyelitis
Pertussis
Keywords: Diphtheria
Tetanus
Poliomyelitis
Pertussis (acellular)
Biological/vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-02-02
Enrollment: 342
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Diphtheria seroprotection rate
timeFrame: 28 to 35 days afeter each vaccine administration
measure: Tetanus seroprotection rate
timeFrame: 28 to 35 days after each vaccine administration
measure: Polio seroprotection rate
timeFrame: 28 to 35 days after each vaccine administration
measure: Pertussis response rate
timeFrame: 28 to 35 days after REPEVAX administration
Secondary outcomes:
measure: Solicited injection-site reactions, solicited systemic reactions
timeFrame: From day 0 to day 7 following REPEVAX and REVAXIS vaccination
measure: Unsolicited injection-site adverse reactions and systemic adverse events
timeFrame: From day 0 to day 28 following REPEVAX and REVAXIS vaccination
measure: Number and proportion of Serious adverse events
timeFrame: From the first vaccination to the last visit of the subject
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Sanofi Pasteur MSD investigational site
city: Lille
country: France
facility: Sanofi Pasteur MSD investigational site
city: Montpellier
country: France
facility: Sanofi Pasteur MSD investigational site
city: Paris
country: France
facility: Sanofi Pasteur MSD investigational site
city: Poitiers
country: France
facility: Sanofi Pasteur MSD investigational site
city: Saint-Etienne
country: France
facility: Sanofi Pasteur MSD investigational site
city: Balve
country: Germany
facility: Sanofi Pasteur MSD investigational site
city: Berlin
country: Germany
facility: Sanofi Pasteur MSD investigational site
city: Dülmen
country: Germany
facility: Sanofi Pasteur MSD investigational site
city: Nürnberg
country: Germany
facility: Sanofi Pasteur MSD investigational site
city: Offenbach
country: Germany
facility: Sanofi Pasteur MSD investigational site
city: Rodgau
country: Germany
facility: Sanofi Pasteur MSD investigational site
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References: