Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Primary objective:
Secondary objectives:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REPEVAX followed by REVAXIS administration | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diphtheria, tetanus, polio and pertussis vaccination | Biological | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Sanofi Pasteur, a Sanofi Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi Pasteur MSD investigational site | Clermont-Ferrand | France | ||||
| Sanofi Pasteur MSD investigational site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Number and proportion of Serious adverse events | From the first vaccination to the last visit of the subject |
| 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 | France |
| 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 | Nuremberg | Germany |
| Sanofi Pasteur MSD investigational site | Offenbach | Germany |
| Sanofi Pasteur MSD investigational site | Rodgau | Germany |
| ID | Term |
|---|---|
| D004165 | Diphtheria |
| D013742 | Tetanus |
| D011051 | Poliomyelitis |
| D014917 | Whooping Cough |
| 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 |
| 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 |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013745 | Tetanus Toxoid |
| ID | Term |
|---|---|
| D014121 | Toxoids |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided