NCT01287949|CompletedPhase 3

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

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

Sanofi Pasteur, a Sanofi Company ClinicalTrials.gov

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1 other identifier

RPV04C

Study Type

interventional

Target

342

Locations

2 countries

Sites

Timeline

RegisteredFeb 2011

StartedJan 2011

CompletionMay 2012

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

342

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jan 2011

Shorter than P25 for phase_3

Geographic Reach

2 countries

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

January 1, 2011

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed

Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

January 31, 2011

Last Update Submit

September 8, 2017

Conditions

Diphtheria Tetanus Poliomyelitis Pertussis

Keywords

DiphtheriaTetanusPoliomyelitisPertussis (acellular)Biological/vaccine

Outcome Measures

Primary Outcomes (4)

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 Outcomes (3)

Solicited injection-site reactions, solicited systemic reactions
From day 0 to day 7 following REPEVAX and REVAXIS vaccination
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

Study Arms (1)

REPEVAX followed by REVAXIS administration

EXPERIMENTAL

Biological: Diphtheria, tetanus, polio and pertussis vaccination

Interventions

Diphtheria, tetanus, polio and pertussis vaccinationBIOLOGICAL

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

REPEVAX followed by REVAXIS administration

Eligibility Criteria

Age40 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Adults aged ≥40 years
No receipt of a booster dose with a tetanus-, diphtheria-containing vaccine within the last 20 years

You may not qualify if:

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

Contact the study team to confirm eligibility.