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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00956046 |
Purpose
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:
| Condition | Intervention | Phase |
|---|---|---|
|
Influenza Swine-origin A/H1N1 Influenza |
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated) Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant) Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated + adjuvant) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Subjects Aged 6 to 35 Months |
| Estimated Enrollment: | 401 |
| Study Start Date: | September 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A/H1N1 Vaccine Group 1
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)
|
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated)
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).
|
|
Experimental: A/H1N1 Vaccine Group 2
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).
|
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated + Adjuvant)
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)
|
|
Experimental: A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 Influenza vaccine formulation 3
|
Biological: Swine A/H1N1 influenza vaccine (split virion, inactivated + adjuvant)
0.5 mL, Intramuscular on Day 0 and Day 21
|
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:
Eligibility| Ages Eligible for Study: | 6 Months to 35 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Finland | |
| Espoo, Finland, FIN-02100 | |
| Helsinki, Finland, FIN-00100 | |
| Helsinki, Finland, FIN-00930 | |
| Järvenpää, Finland, FIN-04400 | |
| Kokkola, Finland, 67100 | |
| Kotka, Finland, FIN-48600 | |
| Kuopio, Finland, FIN-70100 | |
| Lahti, Finland, FIN-15140 | |
| Oulu, Finland, FIN-90220 | |
| Pori, Finland, FIN-28100 | |
| Seinäjoki, Finland, 60100 | |
| Tampere, Finland, FIN-33100 | |
| Turku, Finland, FIN-20520 | |
| Vantaa, Finland, FIN-01300 | |
| Vantaa, Finland, FIN-01600 | |
| Study Director: | Medical Monitor | Sanofi Pasteur Inc. |
More Information
| Responsible Party: | Medical Monitor, Sanofi Pasteur Inc. |
| ClinicalTrials.gov Identifier: | NCT00956046 History of Changes |
| Other Study ID Numbers: | GPF09, UTN: U1111-1111-5029, 2009-013858-32 |
| Study First Received: | August 3, 2009 |
| Last Updated: | July 21, 2011 |
| Health Authority: | Finland: Finnish Medicines Agency |
|
Influenza Pandemic Flu Swine-origin A/H1N1 Influenza Swine-origin Influenza Virus Infants |
|
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Infections |
Respiratory Tract Diseases Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |