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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

Primary Purpose

Diphtheria, Tetanus, Poliomyelitis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Diphtheria, tetanus, polio and pertussis vaccination

About this trial

This is an interventional prevention trial for Diphtheria focused on measuring Diphtheria, Tetanus, Poliomyelitis, Pertussis (acellular), Biological/vaccine

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

REPEVAX followed by REVAXIS administration

Arm Description

Outcomes

Primary Outcome Measures

Diphtheria seroprotection rate

Tetanus seroprotection rate

Polio seroprotection rate

Pertussis response rate

Secondary Outcome Measures

Solicited injection-site reactions, solicited systemic reactions

Unsolicited injection-site adverse reactions and systemic adverse events

Number and proportion of Serious adverse events

Full Information

NCT ID

NCT01287949

First Posted

January 31, 2011

Last Updated

September 8, 2017

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT01287949

Brief Title

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

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

January 2011 (Actual)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi Pasteur, a Sanofi Company

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diphtheria, Tetanus, Poliomyelitis, Pertussis

Keywords

Diphtheria, Tetanus, Poliomyelitis, Pertussis (acellular), Biological/vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

342 (Actual)

8. Arms, Groups, and Interventions

Arm Title

REPEVAX followed by REVAXIS administration

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Diphtheria, tetanus, polio and pertussis vaccination

Intervention Description

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

Primary Outcome Measure Information:

Title

Diphtheria seroprotection rate

Time Frame

28 to 35 days afeter each vaccine administration

Title

Tetanus seroprotection rate

Time Frame

28 to 35 days after each vaccine administration

Title

Polio seroprotection rate

Time Frame

28 to 35 days after each vaccine administration

Title

Pertussis response rate

Time Frame

28 to 35 days after REPEVAX administration

Secondary Outcome Measure Information:

Title

Solicited injection-site reactions, solicited systemic reactions

Time Frame

From day 0 to day 7 following REPEVAX and REVAXIS vaccination

Title

Unsolicited injection-site adverse reactions and systemic adverse events

Time Frame

From day 0 to day 28 following REPEVAX and REVAXIS vaccination

Title

Number and proportion of Serious adverse events

Time Frame

From the first vaccination to the last visit of the subject

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Sanofi Pasteur, a Sanofi Company

Official's Role

Study Director

Facility Information:

Facility Name