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

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287949
• Other study ID #: RPV04C
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2011
• Last updated: September 8, 2017
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

Biological:
• 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

Locations

Country	Name	City	State
France	Sanofi Pasteur MSD investigational site	Clermont-Ferrand
France	Sanofi Pasteur MSD investigational site	Lille
France	Sanofi Pasteur MSD investigational site	Montpellier
France	Sanofi Pasteur MSD investigational site	Paris
France	Sanofi Pasteur MSD investigational site	Poitiers
France	Sanofi Pasteur MSD investigational site	Saint-Etienne
Germany	Sanofi Pasteur MSD investigational site	Balve
Germany	Sanofi Pasteur MSD investigational site	Berlin
Germany	Sanofi Pasteur MSD investigational site	Dülmen
Germany	Sanofi Pasteur MSD investigational site	Nürnberg
Germany	Sanofi Pasteur MSD investigational site	Offenbach
Germany	Sanofi Pasteur MSD investigational site	Rodgau

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi Pasteur, a Sanofi Company

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diphtheria seroprotection rate		28 to 35 days afeter each vaccine administration
Primary	Tetanus seroprotection rate		28 to 35 days after each vaccine administration
Primary	Polio seroprotection rate		28 to 35 days after each vaccine administration
Primary	Pertussis response rate		28 to 35 days after REPEVAX administration
Secondary	Solicited injection-site reactions, solicited systemic reactions		From day 0 to day 7 following REPEVAX and REVAXIS vaccination
Secondary	Unsolicited injection-site adverse reactions and systemic adverse events		From day 0 to day 28 following REPEVAX and REVAXIS vaccination
Secondary	Number and proportion of Serious adverse events		From the first vaccination to the last visit of the subject