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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1111-4918 | |||
| 2009-013344-37 | EudraCT Number |
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The purpose of this study is to generate data on immunogenicity and safety of the monovalent H1N1 vaccine in support of the development and registration.
Primary objectives:
All participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
A subset of the participants will receive a third vaccine injection (2010-2011 Northern Hemisphere [NH] seasonal trivalent influenza vaccine [TIV]) approximately 13 months after the first vaccination; additionally, a subset of participants' naïve to the swine-origin A/H1N1 strain will also receive one vaccine injection of the 2010-2011 NH seasonal TIV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Experimental | All participants will receive A/H1N1 vaccine formulation 1 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13. |
|
| A/H1N1 Vaccine Group 2 | Experimental | All participants will receive A/H1N1 vaccine formulation 2 at Visits 1 and 2; a subset will receive a trivalent influenza vaccine (TIV) at Month 13. |
|
| A/H1N1 Vaccine Group 3 | Experimental | Participants will receive A/H1N1 vaccine formulation 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Swine A/H1N1 influenza vaccine (split virion, inactivated) | Biological | 0.5 mL, Intramuscular on Day 0 and day 21 (all participants); and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset) |
| Measure | Description | Time Frame |
|---|---|---|
| To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccine | 21 days post-vaccination | |
| To provide information concerning the safety in terms of solicited injection site and systemic reactions following vaccination with Swine A/H1N1 influenza vaccine | 0 to7 days post-vaccination and entire study duration |
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Inclusion Criteria :
At Visit 05, for antibody persistence assessment:
At Month 13, for trivalent influenza vaccine (TIV) administration in subjects who received the A/H1N1 influenza vaccine:
- Addendum 2 to Informed Consent Form has been signed and dated
Exclusion Criteria :
At Month 8, for antibody persistence assessment:
- Subjects who received, in the context of a pandemic immunization program, another A/H1N1 pandemic influenza vaccine than the Investigational Medicinal Products.
Additional criteria for subset to receive only the TIV:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Angers | 49000 | France | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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| Swine A/H1N1 influenza vaccine (split virion, inactivated) | Biological | 0.5 mL, Intramuscular on Day 0 and day 21 (all participants), and 0.5 mL of trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset). |
|
| Swine A/H1N1 influenza vaccine (split virion, inactivated) | Biological | 0.5 mL, Intramuscular on Day 0 and Day 21 |
|
| Château-Gontier |
| 53200 |
| France |
| Cherbourg | 50100 | France |
| Équeurdreville-Hainneville | 50120 | France |
| Laval | 53000 | France |
| Tiercé | 49125 | France |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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