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Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old

Primary Purpose

Diphtheria, Tetanus, Pertussis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Concomitant administration

Separate administration

About this trial

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

Eligibility Criteria

60 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Adults aged ≥60 years
At least one documented booster dose with a tetanus- and diphtheria-containing vaccine between 5 and 15 years
No influenza vaccine administered during the last 6 months

Exclusion Criteria:

Receipt of a booster dose with a tetanus or diphtheria- or poliomyelitis- containing vaccine within the last 5 years
Receipt of pertussis-containing vaccine or 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
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 unstable neurological disorders
Known or suspected immune dysfunction
Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination
Chronic disease 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1- VAXIGRIP and REPEVAX concomitantly

2-REPEVAX 28 days after VAXIGRIP

Arm Description

Outcomes

Primary Outcome Measures

Diphtheria seroprotection rate

Tetanus seroprotection rate

Polio seroprotection rate

Pertussis antibody titre

Flu geometric mean of titres ratio

Secondary Outcome Measures

Solicited injection-site reactions, solicited systemic adverse reactions

Unsolicited injection-site adverse reactions and systemic adverse events

Number and proportion of Serious adverse events

Full Information

NCT ID

NCT01249183

First Posted

November 17, 2010

Last Updated

September 8, 2017

Sponsor

Sanofi Pasteur, a Sanofi Company

1. Study Identification

Unique Protocol Identification Number

NCT01249183

Brief Title

Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old

Official Title

An Open-label, Randomised, Multicentre Study to Evaluate the Immunogenicity and Safety of a Booster Dose of Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Adsorbed Vaccine (REPEVAX) Administered Concomitantly Versus Non-concomitantly With an Influenza Vaccine (VAXIGRIP) to Subjects of 60 Years of Age and Older

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (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 objectives: To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately. Secondary objectives: •Secondary immunogenicity objectives: To describe the immune responses 28 days after concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age and older To describe the immune response of VAXIGRIP according to European Medicines Agency criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28) •Secondary safety objective: To describe the safety profile after vaccination in each group

6. Conditions and Keywords

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

Diphtheria, Tetanus, Pertussis, Poliomyelitis

Keywords

Diphtheria, Tetanus, Pertussis (acellular, component), Diphteria, Biological / vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

954 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1- VAXIGRIP and REPEVAX concomitantly

Arm Type

Experimental

Arm Title

2-REPEVAX 28 days after VAXIGRIP

Arm Type

Active Comparator

Intervention Type

Biological

Intervention Name(s)

Concomitant administration

Intervention Description

1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm)

Intervention Type

Biological

Intervention Name(s)

Separate administration

Intervention Description

1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later

Primary Outcome Measure Information:

Title

Diphtheria seroprotection rate

Time Frame

28 to 35 days after vaccine administration

Title

Tetanus seroprotection rate

Time Frame

28 to 35 days after vaccine administration

Title

Polio seroprotection rate

Time Frame

28 to 35 days after vaccine administration

Title

Pertussis antibody titre

Time Frame

28 to 35 days after vaccine administration

Title

Flu geometric mean of titres ratio

Time Frame

28 to 35 days after vaccine administration

Secondary Outcome Measure Information:

Title

Solicited injection-site reactions, solicited systemic adverse reactions

Time Frame

From Day 0 to Day 7 following REPEVAX vaccination

Title

Unsolicited injection-site adverse reactions and systemic adverse events

Time Frame

From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination

Title

Number and proportion of Serious adverse events

Time Frame

From the first visit to the last visit of the subject

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults aged ≥60 years At least one documented booster dose with a tetanus- and diphtheria-containing vaccine between 5 and 15 years No influenza vaccine administered during the last 6 months Exclusion Criteria: Receipt of a booster dose with a tetanus or diphtheria- or poliomyelitis- containing vaccine within the last 5 years Receipt of pertussis-containing vaccine or 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 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 unstable neurological disorders Known or suspected immune dysfunction Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular vaccination Chronic disease 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

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