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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1- VAXIGRIP and REPEVAX concomitantly | Experimental |
| |
| 2-REPEVAX 28 days after VAXIGRIP | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Concomitant administration | Biological | 1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diphtheria seroprotection rate | 28 to 35 days after vaccine administration | |
| Tetanus seroprotection rate | 28 to 35 days after vaccine administration | |
| Polio seroprotection rate | 28 to 35 days after vaccine administration | |
| Pertussis antibody titre | 28 to 35 days after vaccine administration | |
| Flu geometric mean of titres ratio | 28 to 35 days after vaccine administration |
| Measure | Description | Time Frame |
|---|---|---|
| Solicited injection-site reactions, solicited systemic adverse reactions | From Day 0 to Day 7 following REPEVAX vaccination | |
| Unsolicited injection-site adverse reactions and systemic adverse events | From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi Pasteur MSD Investigational Site | Angers | France | ||||
| Sanofi Pasteur MSD Investigational Site |
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| Separate administration | Biological | 1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later |
|
| Number and proportion of Serious adverse events | From the first visit to the last visit of the subject |
| Châtellerault |
| France |
| Sanofi Pasteur MSD Investigational Site | Clermont-Ferrand | France |
| Sanofi Pasteur MSD Investigational Site | Gières | 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 | Tiercé | France |
| Sanofi Pasteur MSD Investigational Site | Tours | France |
| 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 | Germany |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D014917 | Whooping Cough |
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003015 | Clostridium Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
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