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| ID | Type | Description | Link |
|---|---|---|---|
| UTN: U1111-1111-5029 | Other Identifier | WHO | |
| 2009-013858-32 | 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 eligible who received two half-doses of either formulation 1 or 2 will also be proposed to receive the 2010-2011 Northern Hemisphere (NH) seasonal Trivalent Influenza Vaccine (TIV) 13 months after the first vaccination as Follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A/H1N1 Vaccine Group 1 | Experimental | All participants will receive A/H1N1 Influenza vaccine formulation 1 at Visits 1 and 2; and a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset) |
|
| A/H1N1 Vaccine Group 2 | Experimental | All participants will receive A/H1N1 Influenza vaccine formulation 2 at Visits 1 and 2; and a subset will receive a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset). |
|
| A/H1N1 Vaccine Group 3 | Experimental | Participants will receive A/H1N1 Influenza 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 a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset). |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity: To provide information concerning the immunogenicity of Swine A/H1N1 influenza vaccines | 21 days post vaccination | |
| Safety: To provide information concerning the safety in terms of solicited injection site and systemic reactions of Swine A/H1N1 influenza vaccines. | 0-7 days post-vaccination and entire study duration |
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Inclusion Criteria :
All subjects
Subjects ≥ 6 to < 24 months of age - Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg
At Month 8 for antibody persistence assessment:
At Visit 06, for subjects eligible for the Antibody persistence evaluation who will receive the Trivalent Influenza Vaccine (TIV):
- Addendum 2 to Informed Consent Form has been signed by the subject's parents/legal representative.
Exclusion Criteria :
All subjects
Subjects ≥ 6 to < 24 months of age - History of seizures
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.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Sanofi Pasteur Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Espoo | FIN-02100 | Finland | ||||
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| Label | URL |
|---|---|
| Related Info | View source |
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| Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant) | Biological | 0.5 mL, Intramuscular on Day 0 and Day 21 (all participants); and 0.5 mL of a trivalent influenza vaccine (TIV) at Month 13 (antibody persistence subset) |
|
| Swine A/H1N1 influenza vaccine (split virion, inactivated + adjuvant) | Biological | 0.5 mL, Intramuscular on Day 0 and Day 21 |
|
| Helsinki |
| FIN-00100 |
| Finland |
| Helsinki | FIN-00930 | Finland |
| Jarvenpaa | FIN-04400 | Finland |
| Kokkola | 67100 | Finland |
| Kotka | FIN-48600 | Finland |
| Kuopio | FIN-70100 | Finland |
| Lahti | FIN-15140 | Finland |
| Oulu | FIN-90220 | Finland |
| Pori | FIN-28100 | Finland |
| Seinäjoki | 60100 | Finland |
| Tampere | FIN-33100 | Finland |
| Turku | FIN-20520 | Finland |
| Vantaa | FIN-01300 | Finland |
| Vantaa | FIN-01600 | Finland |
| 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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| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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