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

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249183
• Other study ID #: RPV03C
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2010
• Last updated: September 8, 2017
• Start date: October 2010
• Est. completion date: September 2011

Study information

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

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 954
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diphtheria
• Pertussis
• Poliomyelitis
• Tetanus
• Whooping Cough

Intervention

Biological:
• Concomitant administration
1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm)
• Separate administration
1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later

Locations

Country	Name	City	State
France	Sanofi Pasteur MSD Investigational Site	Angers
France	Sanofi Pasteur MSD Investigational Site	Châtellerault
France	Sanofi Pasteur MSD Investigational Site	Clermont-Ferrand
France	Sanofi Pasteur MSD Investigational Site	Gieres
France	Sanofi Pasteur MSD Investigational Site	Grenoble
France	Sanofi Pasteur MSD Investigational Site	Hérouville Saint-Clair
France	Sanofi Pasteur MSD Investigational Site	La Rochelle
France	Sanofi Pasteur MSD Investigational Site	Lyon
France	Sanofi Pasteur MSD Investigational Site	Poitiers
France	Sanofi Pasteur MSD Investigational Site	Strasbourg
France	Sanofi Pasteur MSD Investigational Site	Tierce
France	Sanofi Pasteur MSD Investigational Site	Tours
Germany	Sanofi Pasteur MSD Investigational Site	Berlin
Germany	Sanofi Pasteur MSD Investigational Site	Dresden
Germany	Sanofi Pasteur MSD Investigational Site	Essen
Germany	Sanofi Pasteur MSD Investigational Site	Hamburg
Germany	Sanofi Pasteur MSD Investigational Site	Heilbronn
Germany	Sanofi Pasteur MSD Investigational Site	Künzing
Germany	Sanofi Pasteur MSD Investigational Site	Potsdam
Germany	Sanofi Pasteur MSD Investigational Site	Reichenbach

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 after vaccine administration
Primary	Tetanus seroprotection rate		28 to 35 days after vaccine administration
Primary	Polio seroprotection rate		28 to 35 days after vaccine administration
Primary	Pertussis antibody titre		28 to 35 days after vaccine administration
Primary	Flu geometric mean of titres ratio		28 to 35 days after vaccine administration
Secondary	Solicited injection-site reactions, solicited systemic adverse reactions		From Day 0 to Day 7 following REPEVAX vaccination
Secondary	Unsolicited injection-site adverse reactions and systemic adverse events		From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination
Secondary	Number and proportion of Serious adverse events		From the first visit to the last visit of the subject