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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-05-31

Brief Summary

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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

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Detailed Description

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Conditions

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Diphtheria Tetanus Poliomyelitis Pertussis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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REPEVAX followed by REVAXIS administration

Group Type EXPERIMENTAL

Diphtheria, tetanus, polio and pertussis vaccination

Intervention Type BIOLOGICAL

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

Interventions

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Diphtheria, tetanus, polio and pertussis vaccination

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes